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   2016| May-June  | Volume 20 | Issue 3  
    Online since April 11, 2016

 
 
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ORIGINAL ARTICLES
Vitamin D supplementation reduces thyroid peroxidase antibody levels in patients with autoimmune thyroid disease: An open-labeled randomized controlled trial
Sandeep Chaudhary, Deep Dutta, Manoj Kumar, Sudipta Saha, Samim Ali Mondal, Ashok Kumar, Satinath Mukhopadhyay
May-June 2016, 20(3):391-398
DOI:10.4103/2230-8210.179997  PMID:27186560
Background and Aims: Although Vitamin D deficiency has been linked to autoimmune thyroid disorders (AITD), the impact of Vitamin D supplementation on thyroid autoimmunity is not known. This study aimed to evaluate the impact of Vitamin D supplementation on thyroid autoimmunity (thyroid peroxidase antibody [TPO-Ab] titers) in patients with newly diagnosed AITD in a randomized controlled trial. Materials and Methods: One hundred two patients with newly diagnosed AITD (TPO-Ab > 34 kIU/L and/or sonographic evidence of thyroiditis) patients were randomized into Group-1 (intervention group) and Group-2 (control group). Group-1 received cholecalciferol 60,000 IU weekly and calcium 500 mg/day for 8 weeks; Group-2 received calcium 500 mg/day for 8 weeks. Responders were defined as ≥25% fall in TPO-Ab titers. Individuals with at least 3-month follow-up were analyzed. Trial is registered at ctri.nic.in (CTRI/2015/04/005713). Results: Data from 100 AITD patients (68 with thyroid stimulating hormone [TSH] ≤10 mIU/L, 32 with TSH > 10 mIU/L), 93% having Vitamin D insufficiency, were analyzed. TPO-Ab titers were highest among patients in the lowest 25-hydroxyvitamin D quartile (P = 0.084). At 3 months follow-up, there was significant fall in TPO-Ab in Group-1 (−46.73%) as compared to Group-2 (−16.6%) (P = 0.028). Sixty-eight percentage patients in Group-1 were responders compared to 44% in Group-2 (P = 0.015). Kaplan–Meier analysis revealed significantly higher response rate in Group-1 (P = 0.012). Significantly greater reduction in TPO-Ab titers was observed in AITD with TSH ≤ 10 mIU/L compared to TSH > 10 mIU/L. Cox regression revealed Group-1 followed by TPO-Ab and free tetraiodothyronine levels to be a good predictor of response to therapy (P = 0.042, 0.069, and 0.074, respectively). Conclusion: Vitamin D supplementation in AITD may have a beneficial effect on autoimmunity as evidence by significant reductions in TPO-Ab titers.
  12 3,240 691
Current practices in the diagnosis and management of gestational diabetes mellitus in India (WINGS-5)
Manni Mohanraj Mahalakshmi, Balaji Bhavadharini, Kumar Maheswari, Ranjit Mohan Anjana, Saravanan Jebarani, Lyudmil Ninov, Arivudainamb Kayal, Belma Malanda, Anne Belton, Ram Uma, Viswanathan Mohan, Ranjit Unnikrishnan
May-June 2016, 20(3):364-368
DOI:10.4103/2230-8210.180001  PMID:27186555
Aim: To obtain information on existing practices in the diagnosis and management of gestational diabetes mellitus (GDM) among physicians/diabetologists/endocrinologists and obstetricians/gynecologists (OB/GYNs) in India. Methods: Details regarding diagnostic criteria used, screening methods, management strategies, and the postpartum follow-up of GDM were obtained from physicians/diabetologists/endocrinologists and OB/GYNs across 24 states of India using online/in-person surveys using a structured questionnaire. Results: A total of 3841 doctors participated in the survey of whom 68.6% worked in private clinics. Majority of OB/GYNs (84.9%) preferred universal screening for GDM, and screening in the first trimester was performed by 67% of them. Among the OB/GYNs, 600 (36.7%) reported using the nonfasting 2 h criteria for diagnosing GDM whereas 560 (29.4%) of the diabetologists/endocrinologists reported using the same. However, further questioning on the type of blood sample collected and the glucose load used revealed that, in reality, only 208 (12.7%) and 72 (3.8%), respectively, used these criteria properly. The survey also revealed that the International Association of Diabetes and Pregnancy Study Groups criteria was followed properly by 299 (18.3%) of OB/GYNs and 376 (19.7%) of physicians/diabetologists/endocrinologists. Postpartum oral glucose tolerance testing was advised by 56% of diabetologists and 71.6% of OB/GYNs. Conclusion: More than half of the physicians/diabetologists/endocrinologists and OB/GYNs in India do not follow any of the recommended guidelines for the diagnosis of GDM. This emphasizes the need for increased awareness about screening and diagnosis of GDM both among physicians/diabetologists/endocrinologists and OB/GYNs in India.
  8 1,584 390
Leptin and body mass index in polycystic ovary syndrome
Nasrin Jalilian, Lida Haghnazari, Samira Rasolinia
May-June 2016, 20(3):324-328
DOI:10.4103/2230-8210.180005  PMID:27186548
Objective: Polycystic ovary syndrome (PCOS) is a common endocrine disorder associated with obesity. Human and animal studies showed a direct relationship between leptin level and obesity, however, results from different studies were mixed. This study investigated the status of leptin level in PCOS and its relationship with body mass index (BMI) in a group of Iranian women with PCOS. Methods: In this cross-sectional study, 40 women with PCOS and 36 healthy women were assigned to experimental and control groups, respectively. Those in the PCOS group were not prescribed any medications for 3 months prior to the study. Fasting blood samples were then collected during the 2nd or 3rd day of menstruation for laboratory measurement of serum total leptin, blood glucose (fasting blood sugar), serum insulin, follicle-stimulating hormone, and luteinizing hormone (LH). Results: Mean BMI of the PCOS and control groups were 26.62 ± 4.03 kg/m2 and 23.52 ± 2.52 kg/m2, respectively (P = 0.006). The mean total leptin in the PCO group was also 10.69 ± 5.37 ng/mL and 5.73 ± 2.36 ng/mL in the control group (P = 0.0001). A significant relationship was found between leptin level and BMI as well as LH level among women with PCOS (P < 0.05). However, there was no significant correlation between leptin and insulin (P > 0.05). Conclusion: The results of this study indicated an increased leptin level among women with PCOS that positively associated with BMI and LH.
  7 1,499 370
Efficacy and safety of Vitamin D supplementation during pregnancy: A randomized trial of two different levels of dosing on maternal and neonatal Vitamin D outcome
Shahnaz Ahmad Mir, Shariq Rashid Masoodi, Shafia Shafi, Iqra Hameed, Maqsood Ahmad Dar, Mir Iftikhar Bashir, Arshad Iqbal Wani, Zaffar Amin Shah, Shameema Parveen, Abdul Hamid Zargar, Parviz Ahmad Shah
May-June 2016, 20(3):337-342
DOI:10.4103/2230-8210.179991  PMID:27186550
Introduction: Pregnant women represent a typical group susceptible to dietary and mineral deficiencies. This study was sought to assess the efficacy and safety of various doses of 25-hydroxyvitamin D (25[OH]D) supplementation during pregnancy and ratify the inadequacy of the recommended daily allowance for Vitamin D in vulnerable groups. Materials and Methods: A total of 100 pregnant women were included in this open-label, parallel group, prospective, randomized, and controlled trial. Study subjects were assigned to four treatment groups: Group 1 (n = 26), 1000 IU of Vitamin D daily; Group 2 (n = 21), 30,000 IU of Vitamin D monthly; Group 3 (n = 27), 2000 IU of Vitamin D daily; and Group 4 (n = 26), 60,000 IU Vitamin D monthly. Group 1 and 2 were further analyzed together as Group 1K (1000 IU daily and 30,000 IU monthly), and Group 3 and 4 as Group 2K (2000 IU daily and 60,000 IU monthly). The analysis was done on an intention to treat basis. Results: A total of 87 patients completed the study; 21 in Group 1, 25 in Group 2, 18 in Group 3, and 23 in Group 4. The levels of 25(OH)D at baseline ranged from 1.3 to 58.0 with a mean of 24.2 ± 15.1 ng/ml. Postsupplementation, 25(OH)D levels ranged from 11.5 to 70.3 with a mean of 40.2 ± 12.2 ng/ml. The postsupplementation levels of 25(OH)D were higher in Group 2K (42.86 ± 12.83) than in Group 1K (36.96 ± 10.56) with P value of 0.023. Conclusion: We concluded that Vitamin D supplementation with 2000 IU/day or 60,000 IU/month is very effective and safe in achieving Vitamin D sufficiency in pregnant women.
  6 2,288 494
BRIEF COMMUNICATION
Flexibility in insulin prescription
Sanjay Kalra, Yashdeep Gupta, Ambika Gopalakrishnan Unnikrishnan
May-June 2016, 20(3):408-411
DOI:10.4103/2230-8210.180003  PMID:27186563
This communication explores the concept of flexibility, a propos insulin preparations and insulin regimes used in the management of type 2 diabetes. The flexibility of an insulin regime or preparation is defined as their ability to be injected at variable times, with variable injection-meal time gaps, in a dose frequency and quantum determined by shared decision making, with a minimal requirement of glucose monitoring and health professional consultation, with no compromise on safety, efficiency and tolerability. The relative flexibility of various basal, prandial and dual action insulins, as well as intensive regimes, is compared. The biopsychosocial model of health is used to assess the utility of different insulins while encouraging a philosophy of flexible insulin usage.
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ORIGINAL ARTICLES
Efficacy and safety of canagliflozin in patients with type 2 diabetes mellitus from India
KM Prasanna Kumar, Viswanathan Mohan, Bipin Sethi, Pramod Gandhi, Ganapathi Bantwal, John Xie, Gary Meininger, Rong Qiu
May-June 2016, 20(3):372-380
DOI:10.4103/2230-8210.179996  PMID:27186557
Background: This post hoc analysis evaluated the efficacy and safety of canagliflozin, a sodium glucose co-transporter 2 inhibitor, in patients with type 2 diabetes mellitus (T2DM) from India. Methods: Changes from baseline in HbA1c, fasting plasma glucose (FPG), body weight, and blood pressure (BP) with canagliflozin 100 and 300 mg were evaluated in a subgroup of patients from India (n = 124) from 4 randomized, double-blind, placebo- and active-controlled, Phase 3 studies (N = 2313; Population 1). Safety was assessed based on adverse event (AE) reports in these patients and in a broader subgroup of patients from India (n = 1038) from 8 randomized, double-blind, placebo- and active-controlled, Phase 3 studies (N = 9439; Population 2). Results: Reductions in HbA1cwith canagliflozin 100 and 300 mg were −0.74% and −0.88%, respectively, in patients from India, and −0.81% and −1.00%, respectively, in the 4 pooled Phase 3 studies. In the Indian subgroup, both canagliflozin doses provided reductions in FPG, body weight, and BP that were consistent with findings in the overall population. The incidence of overall AEs in patients from India was generally similar with canagliflozin 100 and 300 mg and noncanagliflozin. The AE profile in patients from India was generally similar to the overall population, with higher rates of genital mycotic infections and osmotic diuresis–related and volume depletion–related AEs with canagliflozin versus noncanagliflozin. Conclusion: Canagliflozin provided glycemic control, body weight reduction, and was generally well tolerated in patients with T2DM from India.
  5 1,505 397
EDITORIALS
The law of therapeutic parsimony
Sanjay Kalra, Yashdeep Gupta, Rakesh Sahay
May-June 2016, 20(3):283-284
DOI:10.4103/2230-8210.180008  PMID:27186541
  3 1,161 293
ORIGINAL ARTICLES
Adherence to diabetes care processes at general practices in the National Capital Region-Delhi, India
Roopa Shivashankar, Sandeep Bhalla, Dimple Kondal, Mohammed K Ali, Dorairaj Prabhakaran, KM Venkat Narayan, Nikhil Tandon
May-June 2016, 20(3):329-336
DOI:10.4103/2230-8210.180000  PMID:27186549
Aim: To assess the level of adherence to diabetes care processes, and associated clinic and patient factors at general practices in Delhi, India. Methods: We interviewed physicians (n = 23) and patients with diabetes (n = 406), and reviewed patient charts at general practices (government = 5; private = 18). We examined diabetes care processes, specifically measurement of weight, blood pressure (BP), glycated hemoglobin (HbA1c), lipids, electrocardiogram, dilated eye, and a foot examination in the last one year. We analyzed clinic and patient factors associated with a number of care processes achieved using multilevel Poisson regression model. Results: The average number of clinic visits per patient was 8.8/year (standard deviation = 5.7), and physicians had access to patient's previous records in only 19.7% of patients. Dilated eye exam, foot exam, and electrocardiogram were completed in 7.4%, 15.1%, and 29.1% of patients, respectively. An estimated 51.7%, 88.4%, and 28.1% had ≥1 measurement of HbA1c, BP, and lipids, respectively. Private clinics, physician access to patient's previous records, use of nonphysicians, patient education, and the presence of diabetes complication were positively associated with a number of care processes in the multivariable model. Conclusion: Adherence to diabetes care processes was suboptimal. Encouraging implementation of quality improvement strategies like Chronic Care Model elements at general practices may improve diabetes care.
  3 1,051 251
Th1/Th2 cytokines in Type 1 diabetes: Relation to duration of disease and gender
Hajar Vaseghi, Zohreh Jadali
May-June 2016, 20(3):312-316
DOI:10.4103/2230-8210.180002  PMID:27186546
Background: T-cells are important in the pathogenesis of Type 1 diabetes (T1D). However, the exact role of T-cell subpopulations in this pathway remains unknown. The purpose of this study was to assess the expression pattern of T helper 1 (Th1) interferon-gamma (IFN-γ) and Th2 interleukin-4 (IL-4) cytokines and their relationship with sex and disease duration in T1D patients. Materials and Methods: This study was conducted on 21 T1D patients and 22 healthy subjects. Gene expression analysis of peripheral blood mononuclear cells (PBMCs) was performed using real-time reverse transcriptase polymerase chain reaction. Results: IFN-γ gene expression was significantly lower in T1D patients compared with controls (P < 0.05). Conversely, IL-4 mRNAs were significantly increased in the PBMCs from patients as compared to controls (P < 0.05). There was no significant difference in the expression of IL-4 and IFN-γ between men and women with T1D (P > 0.05) while IL-4 mRNA expression in male patients was about 1.9 folds higher than female patients. Moreover, IFN-γ mRNA expression in female patients was about 1.8 folds lower than male patients. Patients were divided into two groups regarding their disease duration: <10 years and >10 years. A significant increase in the IL-4 expression was observed between two groups of patients compared to controls (P < 0.0001). Conversely, there was a significant difference in the expression of IFN-γ only between patients with more than 10 years of disease duration (P = 0.02). Conclusion: These data propose supplementary implications for the role of Th1/Th2 imbalance in T1D immunopathogenesis. Moreover, factors such as sex and disease duration may have some influence on cytokine mRNA expression.
  3 1,111 248
Effect of maternal and neonatal factors on cord blood thyroid stimulating hormone
Sheetal G Lakshminarayana, Nidhish P Sadanandan, AK Mehaboob, Lakshminarayana R Gopaliah
May-June 2016, 20(3):317-323
DOI:10.4103/2230-8210.179998  PMID:27186547
Background: Congenital hypothyroidism (CH) is most common preventable cause of mental retardation in children. Cord blood Thyroid Stimulating Hormone (CBTSH) level is an accepted screening tool for CH. Objectives: To study CBTSH profile in neonates born at tertiary care referral center and to analyze the influence of maternal and neonatal factors on their levels. Design: Cross retrospective sectional study. Methods: Study population included 979 neonates (males = 506 to females = 473). The CBTSH levels were estimated using electrochemiluminescence immunoassay on Cobas analyzer. Kit based cut-offs of TSH level were used for analysis. All neonates with abnormal CBSTH levels, were started on levothyroxine supplementation 10 μg/Kg/day and TSH levels were reassessed as per departmental protocol. Results: The mean CBTSH was 7.82 μIU/mL (Range 0.112 to 81.4, SD = 5.48). The mean CBTSH level was significantly higher in first order neonates, neonates delivered by assisted vaginal delivery and normal delivery, delivered at term or preterm, neonates with APGAR score <5 and those needing advanced resuscitation after birth. The CBTSH level >16.10 and <1.0 μIU/mL was found in 4.39 % and 1.02 % neonates respectively. The prevalence rate of CBTSH level >16.1 μIU/mL was significantly higher in neonates delivered by assisted vaginal delivery and normal delivery, term and preterm neonates, APAGR score of <5, presence of fetal distress, need for resuscitation beyond initial steps and in those with birth weight of <1.5 Kg. Three neonates were confirmed to have CH after retesting of TSH level. Conclusions: The CBTSH estimation is an easy, non-invasive method for screening for CH. The cutoff level of CB TSH (μIU/mL) >16.10 and <1.0 led to a recall of 5.41% of neonates which is practicable given the scenario in our Country. The mode of delivery and perinatal stress factors have a significant impact on CBTSH levels and any rise to be seen in the light of these factors. The prevalence rate of CH after recall was ~3 in 1000 live births.
  3 1,509 355
Association of type 1 diabetes mellitus and autoimmune disorders in Brazilian children and adolescents
Crésio Alves, Larissa Siqueira Santos, Maria Betânia P Toralles
May-June 2016, 20(3):381-386
DOI:10.4103/2230-8210.179994  PMID:27186558
Context: Type 1 diabetes mellitus (T1DM) is caused by an immune-mediated destruction of pancreatic beta cells. Other autoimmune diseases can be observed in association with T1DM. The screening for celiac disease (CD) and Hashimoto's thyroiditis is necessary due to the increased prevalence of these pathologies in T1DM patients. Aims: This study aimed to investigate the prevalence of autoimmune markers for pancreatitis, thyroiditis, and CD in racially admixtured children and adolescents with T1DM. Settings and Design: Cross-sectional clinic-based study. Methods: Seventy-one patients with T1DM (average: 11.6 ± 5.1 years). In all patients, the following antibodies were surveyed: Anti-glutamic acid decarboxylase (anti-GAD), immunoglobulin A (IgA) anti-transglutaminase (anti-tTG), Antithyroglobulin (AAT), anti-thyroid peroxidase (anti-TPO), and IgA. Statistical Analysis Used: The quantitative variables were expressed as a mean and standard deviation and the qualitative variables in contingency tables. Student's t-test and χ2 tests were used to assess the differences between the groups. The level of significance was established as P < 0.05. Results: The prevalence of anti-GAD antibodies was 5.9%; anti-tTG IgA, 7.4%; anti-TPO, 11.8%; and AAT, 11.8%. Conclusions: Children and adolescents with T1DM have increased the prevalence of antithyroid and CD-related antibodies. The positivity for anti-GAD and antithyroid antibodies was less frequent than in other studies. The prevalence of anti-tTG antibodies was similar to the literature.
  3 1,263 319
Prevalence of hypothyroidism in pregnancy: An epidemiological study from 11 cities in 9 states of India
Dinesh Kumar Dhanwal, Sarita Bajaj, Rajesh Rajput, K. A. V. Subramaniam, Subhankar Chowdhury, Rajendra Bhandari, Mala Dharmalingam, Rakesh Sahay, Ashraf Ganie, Narendra Kotwal, Usha Shriram
May-June 2016, 20(3):387-390
DOI:10.4103/2230-8210.179992  PMID:27186559
Background: A previous hospital based study from Delhi revealed a high prevalence of hypothyroidism in pregnant women. Several other studies with small sample size also indicate a rising trend of prevalence of hypothyroidism during pregnancy in India. Objective: To assess prevalence of hypothyroidism in pregnant women from various states/cities across India. Materials and Methods: This was a cross-sectional multicenter study conducted at Allahabad (Uttar Pradesh), Bengaluru (Karnataka), Chennai (Tamil Nadu), Kolkata (West Bengal), Hyderabad (Telangana), Nasik (Maharashtra), Rohtak (Haryana), Pune (Maharashtra), New Delhi (Delhi), Srinagar (Kashmir), and Vizag (Andhra Pradesh) enrolling 2599 pregnant women. Estimation of thyroid stimulating hormone (TSH), free T4, and antithyroid peroxidase (TPO) antibodies was carried out using Roche modular kit using ECLIA technology in a central laboratory. Results: We found in our study population that 13.13% of pregnant women have hypothyroidism (n = 388), using a cutoff TSH level of 4.5 μIU/ml. This prevalence was much higher using the American Thyroid Association criteria. Anti-TPO antibodies were positive in 20.74% of all pregnant women (n = 613), whereas 40% (n = 155) of hypothyroid pregnant women were positive for anti-TPO antibodies. Conclusion: This study concludes that there is a high prevalence of hypothyroidism (13.13%), majority being subclinical in pregnant women during the first trimester from India and universal screening of hypothyroidism may be desirable in our country.
  3 3,985 749
ENDOCRINOLOGY AND ART
The Mahabharata and reproductive endocrinology
Bharti Kalra, Manash P Baruah, Sanjay Kalra
May-June 2016, 20(3):404-407
DOI:10.4103/2230-8210.180004  PMID:27186562
This communication approaches the Mahabharata through the prism of reproductive endocrinology. Descriptions of episodes related to reproduction are listed here, to provide fodder for the endocrinologically minded brain. The cases described here are perhaps, the first documented observations of fetal orgasm, pseudocyesis and assisted reproductive technology, including assisted insemination by donor, induction of ovulation, and in vitro fertilization as well as precocious growth and intersex. We do not presume to offer a definite explanation for these interesting episodes from the Mahabharata. We do, however, hope to stimulate interest in ancient Indian literature, and encourage a literary “forensic endocrine” analysis of events relevant to our specialty.
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ORIGINAL ARTICLES
Awareness among tertiary care doctors about Pharmacovigilance Programme of India: Do endocrinologists differ from others?
Pramod Kumar Sharma, Surjit Singh, Puneet Dhamija
May-June 2016, 20(3):343-347
DOI:10.4103/2230-8210.180007  PMID:27186551
Background and Objectives: Reporting adverse drug reactions (ADRs) associated with drug use is an important factor in patient safety. Majority of ADRs are preventable through improved prescribing and monitoring. Endocrinologists prescribe drugs with actions on almost all organs and for relatively longer durations. ADR are expected following the use of these drugs. Pharmacovigilance is the study of drug-related adverse effects aimed at protecting patients and public from drug-related harms. The concept of pharmacovigilance is relatively new in India, and this survey is an attempt to explore awareness among doctors of an establishing institution of national importance. Materials and Methods: The survey was conducted on faculty and resident doctors by administering a written structured questionnaire in a voluntary manner. The questionnaire contained questions meant to evaluate their awareness, understanding, and misconception about ADR reporting. Identity of the responder was kept confidential. Results: A total of 106 (faculty = 56; residents = 50) participated in survey. The most common cause cited for not reporting an ADR was “do not know how to report” by 64.15%. Majority of them (64%) had no information about the Pharmacovigilance Programme of India (PvPI), and only few (8.5%) had actually reported or published an ADR. Interpretation and Conclusions: ADRs are major public health problem that needs to be addressed at all levels of health care. High index of clinical suspicion are crucial for their timely detection and management. Various educational interventions have shown to improve medical professionals' awareness, understanding about ADRs and in their reporting behavior. PvPI is an important initiative toward ensuring patient safety.
  1 1,106 208
Evaluation of oxidative stress and thyroid hormone status in hemodialysis patients in Gorgan
Javad Velayeti, Azad Reza Mansourian, Mohammad Mojerloo, Abdoljalal Marjani
May-June 2016, 20(3):348-353
DOI:10.4103/2230-8210.179986  PMID:27186552
Aims: The aim of this study focused on serum malondialdehyde (MDA) levels and erythrocyte superoxide dismutase (SOD) and catalase (CAT) activities in hemodialysis patients and compared with control groups. Materials and Methods: Forty-five hemodialyzed patients and 45 control groups recruited in this study. Serum creatinine and urea, thyroid hormones (THs) levels and erythrocyte antioxidant enzyme activities were determined. Results: Hemodialysis (HD) patients showed higher levels of MDA than control groups (P < 0.01), but the levels of thyroxin (T3), free triiodothyronine (fT3), and free thyroxin (fT4), SOD and CAT were low in HD patients (P < 0.01). Serum T3, fT3, and fT4 levels were significantly negative correlated with MDA (P < 0.01). Conclusion: It is concluded that serum lipid peroxidation is markedly increased in HD patients. This means that elevated reactive oxygen species may interact with the lipid molecules in HD patients. HD may cause significant changes in TH levels. Thyroid-stimulating hormone level in HD patients is slightly similar to that of control groups. This suggests that thyroid is able to resynthesize for hormonal urinary losses.
  1 1,051 237
Insulin degludec aspart: One-year real world experience
Sanjay Kalra, Manash P Baruah
May-June 2016, 20(3):369-371
DOI:10.4103/2230-8210.177416  PMID:27186556
Background: This retrospective analysis describes the use of insulin degludec aspart (IDegAsp) in India. Material and Methods: All subjects who had received IDegAsp for 52 weeks at two endocrine centers were included in this study. Results: Forty-eight subjects (40 men), with mean age of 54.33 ± 9.63 years and mean duration of diabetes of 6.33 ± 2.96 years, started IDegAsp as insulin of initiation (16), as an intensification regime (4), as de-escalation from basal-bolus therapy (16), or as switch from premixed insulin (12). The dose of IDegAsp fell from 43.17 ± 21.18 U/day or 0.56 ± 0.23 U/kg to 37.75 ± 17.13U/day (0.51 ± 0.12 U/kg) at 24 weeks and 41.41 ± 15.33 U/day (0.56 ± 0.17 U/kg) at 52 weeks. Hemoglobin A1c (HbA1c), which was 9.52 ± 1.27% at the start of therapy, fell to 7.51 ± 0.46% at 26 weeks and to 7.48 ± 0.40% at 52 weeks. Fasting plasma glucose fell from 154.08 ± 33.30 mg% to 108.58 ± 22.26 mg% at 26 weeks and 102.17 ± 12.79 mg% at 52 weeks. Of the 48 subjects, 39 (81.25%) achieved a target of HbA1c <7.0% at both 26 and 52 weeks. No episode of hypoglycemia was reported in the 4 weeks preceding the analysis. Conclusion: This communication highlights the efficacy, safety, and tolerability, while providing insight into the usage patterns of IDegAsp.
  1 1,238 454
Outcome and preferences in female-to-male subjects with gender dysphoria: Experience from Eastern India
Anirban Majumder, Debmalya Sanyal
May-June 2016, 20(3):308-311
DOI:10.4103/2230-8210.179988  PMID:27186545
Context: Awareness of gender dysphoria (GD) and its treatment is increasing. There is paucity of scientific data from India regarding the therapeutic options being used for alleviating GD, which includes psychotherapy, hormone, and surgical treatments. Aim: To study the therapeutic options including psychotherapy, hormone, and surgical treatments used for alleviating GD. Settings and Design: This is a retrospective study of treatment preferences and outcome in 18 female-to-male (FTM) transgender subjects who presented to the endocrine clinic. Results: The mean follow-up was 1.6 years and only one subject was lost to follow-up after a single visit. All subjects desiring treatment had regular counseling and medical monitoring. All FTM subjects were cross-dressing. Seventeen (94.4%) FTM subjects were receiving cross-sex hormone therapy, in the form of testosterone only (61.1%) or gonadotropin-releasing hormone (GnRH) agonist in combination with testosterone (11.1%) or medroxyprogesterone acetate (MPA) depot in combination with testosterone (22.2%). FTM subjects preferred testosterone or testosterone plus MPA; very few could afford GnRH therapy. Testosterone esters injection was preferred by most (72.2%) subjects as it was most affordable while 22.2% chose 3 monthly injections of testosterone undecanoate for convenience and better symptomatic improvement, but it was more expensive. None preferred testosterone gels because of cost and availability concerns. About 33.3% of our subjects underwent mastectomy, 38.9% had hysterectomy with bilateral salpingo-oophorectomy, and only one subject underwent phalloplasty. About 16.7% of FTM subjects presented with prior mastectomy depicting a high prevalence of unsupervised or poorly supervised surgeries not following protocol wise approach. Conclusion: Notwithstanding of advances in Standards of Care in the Western world, there is lack of awareness and acceptance in the FTM subjects, about proper and timely protocol-wise management options leading to suboptimal physical, social, and sexual results.
  1 2,482 343
Estimation of thyroglobulin in lymph node aspirates: Pilot experience from a tertiary referral cancer center
Subramanian Kannan, Subhra Chauhan, Naveen , BS Latha, Nalini Raju, Naveen Hedne Chandrasekhar, Vikram Kekatpure, Moni Abraham Kuriakose, P Manjunath
May-June 2016, 20(3):359-363
DOI:10.4103/2230-8210.179987  PMID:27186554
Background: Assessment of cervical lymph node involvement in patients with thyroid cancer either during preoperative surgical mapping or detection of recurrences during follow-up is a crucial step in the management of differentiated thyroid cancers (DTCs). In most patients, fine needle aspiration cytology (FNAC) confirms the presence of metastasis in lymph node. However, in cases of paucicellular lymph node aspirate or discordant sonogram and cytology results, thyroglobulin (Tg) measurement in the lymph node aspirate (FNA-Tg) is useful and a value >1 ng/ml is considered consistent with metastatic disease. Context: The addition of FNAC to the US improves the specificity, but 5–10% are nondiagnostic and 6–8% rate of false-negative results. Several studies have reported that the detection of Tg in FNA-needle washes improves the evaluation of suspicious lymph nodes in patients with DTC.Data from Indian centers on FNA-Tg are limited. Aims: We piloted the utility of FNA-Tg in patients with sonographically suspicious cervical lymph node enlargement in the setting of suspicious thyroid nodule or in the follow-up of thyroid cancer. Settings and Design: Prospective data collection. Results: We measured Tg in 13 lymph node aspirates (12 patients, 10 females) among whom 4 patients had a total thyroidectomy and 1 had a hemithyroidectomy. Eight of the 13 lymph node aspirates had FNA-Tg values >150 ng/ml, all of them had unequivocal malignant cytology and four among them had proven metastatic DTC on surgical pathology. The median FNA-Tg of the patients with malignant cytology was 7550 ng/ml with a range of 162–30,000 ng/ml. Among the remaining 5 lymph node aspirate, 2 lymph nodes showed cytological features suggestive of reactive lymphadenitis (FNA-Tg <0.2 ng/ml) and were not operated, 1 had a high-grade malignancy consistent with anaplastic thyroid cancer (FNA-Tg <0.2 ng/ml), and 2 had nondiagnostic cytology (one had non-caseating granuloma on surgical pathology [FNA-Tg 1.3 ng/ml] and in the other patient [FNA-Tg <0.2 ng/ml] surgical intervention was deferred). Conclusions: FNA-Tg was concordant with positive cytology in all patients with DTC and may serve as a useful tool in patients with negative and nondiagnostic cytology to guide surgical management.
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REVIEW ARTICLE
Efficacy and safety of biphasic insulin aspart and biphasic insulin lispro mix in patients with type 2 diabetes: A review of the literature
Ajay Kumar
May-June 2016, 20(3):288-299
DOI:10.4103/2230-8210.179993  PMID:27186543
Type 2 diabetes (T2D) represents an escalating burden worldwide, particularly in China and India. Compared with Caucasians, Asian people with diabetes have lower body mass index, increased visceral adiposity, and postprandial glucose (PPG)/insulin resistance. Since postprandial hyperglycemia contributes significantly to total glycemic burden and is associated with heightened cardiovascular risk, targeting PPG early in T2D is paramount. Premixed insulin regimens are widely used in Asia due to their convenience and effectiveness. Data from randomized controlled trials and observational studies comparing efficacy and safety of biphasic insulin aspart 30 (BIAsp 30) with biphasic insulin lispro mix (LM 25/50) and versus other insulin therapies or oral antidiabetic drugs (OADs) in T2D demonstrated that BIAsp 30 and LM 25/50 were associated with similar or greater improvements in glycemic control versus comparator regimens, such as basal–bolus insulin, in insulin-naÏve, and prior insulin users. Studies directly comparing BIAsp 30 and LM 25 provided conflicting glycemic control results. Safety data generally showed increased hypoglycemia and weight gain with premixed insulins versus basal–bolus insulin or OADs. However, large observational trials documented improvements in glycated hemoglobin, PPG, and hypoglycemia with BIAsp 30 in multi-ethnic patient populations. In summary, this literature review demonstrates that premixed insulin regimens are an appropriate and effective treatment choice in T2D.
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EDITORIALS
The Draupadi of dyslipidemia: Familial hypercholesterolemia
Sanjay Kalra, JPS Sawhney, Rakesh Sahay
May-June 2016, 20(3):285-287
DOI:10.4103/2230-8210.179985  PMID:27186542
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LETTERS TO THE EDITOR
National List of Essential Medicines, 2015: Endocrinology perspective
Sanjay Kalra
May-June 2016, 20(3):412-413
DOI:10.4103/2230-8210.180006  PMID:27186564
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HbA1c for diabetes screening in acute coronary syndrome: National Institute for Health and Care Excellence criteria and universal screening
Beuy Joob, Viroj Wiwanitkit
May-June 2016, 20(3):413-414
DOI:10.4103/2230-8210.179989  PMID:27186565
  - 639 176
ORIGINAL ARTICLES
Bilateral inferior petrosal sinus sampling using vasopressin
Narendra Kotwal, Yogesh Kumar, Vimal Upreti, Amandeep Singh, MK Garg
May-June 2016, 20(3):399-403
DOI:10.4103/2230-8210.179995  PMID:27186561
Context: Anatomical localization of pituitary adenoma can be challenging in adrenocorticotropic hormone (ACTH)-dependent Cushing's syndrome, and bilateral inferior petrosal sinus sampling (BIPSS) is considered gold standard in this regard. Stimulation using corticotrophin-releasing hormone (CRH) improves the sensitivity of BIPSS, however, same is not easily available in India. Therefore, we undertook this study of BIPPS using vasopressin as agent for stimulation owing to its ability to stimulate V3 receptors present on corticotrophs. Aims: To study the tumor localization and lateralization in difficult to localize cases of ACTH-dependent Cushing's syndrome by bilateral inferior petrosal sinus sampling using vasopressin for corticotroph stimulation. Settings and Design: Prospective observational study. Subjects and Methods: Six patients (5 females) meeting inclusion criteria underwent BIPSS using vasopressin for stimulation. Results: All six patients had nonsuppressible overnight and low dose dexamethasone suppression test with elevated plasma ACTH levels suggestive of ACTH-dependent Cushing's syndrome. High dose dexamethasone suppression test showed suppressible cortisol in two cases, and microadenoma was seen in two patients on magnetic resonance imaging pituitary. Contrast enhanced computed tomography of the abdomen showed left adrenal hyperplasia in one case and anterior mediastinal mass with bilateral adrenal hyperplasia another. Using BIPSS four patients were classified as having Cushing's disease that was confirmed histopathologically following surgery. Of the remaining two, one had primary pigmented nodular adrenocortical disease, and another had thymic carcinoid with ectopic ACTH production as the cause of Cushing's syndrome. No serious adverse events were noted. Conclusions: Vasopressin may be used instead of CRH and desmopressin for stimulation in BIPSS.
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Clinical, hormonal and radiological profile of 46XY disorders of sexual development
Chauhan Vasundhera, Viveka P Jyotsna, Devasenathipathy Kandasamy, Nandita Gupta
May-June 2016, 20(3):300-307
DOI:10.4103/2230-8210.179999  PMID:27186544
Background and Objectives: 46 XY disorders of sexual development (DSD) cover a wide spectrum of phenotypes ranging from unambiguous female genitalia to ambiguous male genitalia with hypospadias or dysgenetic gonads. Management of these patients depends on the cause of DSD, degree of feminization, age at presentation, and gender orientation. The aim of this study was to evaluate the presentation and management of patients with 46XY DSD at our center. Patients and Methods: All new and old patients of 46XY DSD attending the endocrine OPD in a period of 16 months were included in this study. Clinical, cytogenetic, hormonal, and radiological evaluation were done to identify the cause of DSD. Results: Among 19 patients, eight were diagnosed with disorders of gonadal development (one with complete gonadal dysgenesis, four with partial gonadal dysgenesis, two with congenital bilateral anorchia, and one with ovotesticular DSD) and eight with disorders of androgen synthesis and action (one with complete androgen insensitivity syndrome [AIS], three with partial AIS and four with 5α reductase deficiency). In three patients, a definitive diagnosis could not be made. Conclusions: Management of patients with DSD depends on etiology, gender assignment, gender orientation, hormonal treatment, genital surgery, and consequent psychosocial implications. Due to the overlapping clinical and biochemical parameters in different subsets of DSD, only a preliminary etiological diagnosis can be made in some cases. Genetic studies with long-term follow-up are required for an accurate diagnosis.
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Study of differences in presentation, risk factors and management in diabetic and nondiabetic patients with acute coronary syndrome
Krishna Kumar Sharma, Mukul Mathur, Sailesh Lodha, Surendra Kumar Sharma, Niharika Sharma, Rajeev Gupta
May-June 2016, 20(3):354-358
DOI:10.4103/2230-8210.179990  PMID:27186553
Objectives: To compare clinical characteristics, treatment, and utilization of evidence-based medicines at discharge from hospital in acute coronary syndrome (ACS) patients with or without diabetes at a tertiary care cardiac center in India. Methods: We performed an observational study in consecutive patients discharged following management of ACS. We obtained demographic details, comorbid conditions, and cardiovascular risk factors, physical and biochemical parameters, and management. Descriptive statistics are reported. Results: We enrolled 100 patients (diabetics = 28) with mean age of 59.0 ± 10.8 years (diabetics 59.3 ± 11.6, nondiabetics 58.9 ± 8.5). Forty-nine patients had ST-elevation myocardial infarction (STEMI) (diabetics = 14, 28.7%) while 51 had nonSTEMI/unstable angina (diabetics = 14, 27.4%) (P = nonsignificant). Among diabetics versus nondiabetics there was greater prevalence (%) of hypertension (78.6% vs. 44.4%), obesity (25.0% vs. 8.3%), abdominal obesity (85.7% vs. 69.4%) and sedentary activity (89.2% vs. 77.8%), and lower prevalence of smoking/tobacco use (10.7% vs. 25.0%) (P < 0.05). In STEMI patients 28 (57.1%) were thrombolysed (diabetes 17.8% vs. 31.9%), percutaneous coronary interventions (PCI) was in 67.8% diabetics versus 84.7% nondiabetics and coronary bypass surgery in 21.4% versus 8.3%. At discharge, in diabetics versus nondiabetics, there was similar use of angiotensin converting enzyme inhibitors (67.9% vs. 69.4%) and statins (100.0% vs. 98.6%) while use of dual antiplatelet therapy (85.7% vs. 95.8%) and beta-blockers (64.3% vs. 73.6%) was lower (P < 0.05). Conclusions: Diabetic patients with ACS have greater prevalence of cardiometabolic risk factors (obesity, abdominal obesity, and hypertension) as compared to nondiabetic patients. Less diabetic patients undergo PCIs and receive lesser dual anti-platelet therapy and beta-blockers.
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