Rationale, study design and methodology of the LANDMARC trial: a 3-year, pan-India, prospective, longitudinal study to assess management and real-world outcomes of diabetes mellitus.

AIM: India contributes towards a large part of the worldwide epidemic of diabetes and its associated complications. However, there are limited longitudinal studies available in India to understand the occurrence of diabetes complications over time. This pan-India longitudinal study was initiated to assess the real-world outcomes of diabetes across the country. METHODS: The LANDMARC study is the first prospective, multicentre, longitudinal, observational study investigating a large cohort of people with type 2 diabetes mellitus across India over a period of 3 years. The primary objective of this ongoing study is to determine the proportion of people developing macrovascular diabetes complications over the duration of the study (36 months ± 45 days) distributed over seven visits; the secondary objective is to evaluate microvascular diabetes complications, glycaemic control and time-to-treatment adaptation or intensification. Overall, 6300 participants (aged 25-60 years) diagnosed with type 2 diabetes for at least 2 years will be included from 450 centres across India. Data will be recorded for baseline demographics, comorbidities, glycaemic measurements, use of anti-hyperglycaemic medications and any cardiovascular or other diabetes-related events occurring during the observational study period. CONCLUSIONS: The LANDMARC study is expected to reveal the trends in complications associated with diabetes, treatment strategies used by physicians, and correlation among treatment, control and complications of diabetes within the Indian context. The findings of this study will help to identify the disease burden, emergence of early-onset complications and dose titration patterns, and eventually develop person-centred care and facilitate public health agencies to invest appropriate resources in the management of diabetes. (Trial Registration No: CTRI/2017/05/008452).

The LongitudinAl Nationwide stuDy on Management And Real-world outComes of diabetes in India over 3 years (LANDMARC trial).

INTRODUCTION: LANDMARC (CTRI/2017/05/008452), a prospective, observational real-world study, evaluated the occurrence of diabetes complications, glycemic control and treatment patterns in people with type 2 diabetes mellitus (T2DM) from pan-India regions over a period of 3 years. METHODS: Participants with T2DM (≥25 to ≤60 years old at diagnosis, diabetes duration ≥2 years at the time of enrollment, with/without glycemic control and on ≥2 antidiabetic therapies) were included. The proportion of participants with macrovascular and microvascular complications, glycemic control and time to treatment adaptation over 36 months were assessed. RESULTS: Of the 6234 participants enrolled, 5273 completed 3 years follow-up. At the end of 3-years, 205 (3.3%) and 1121 (18.0%) participants reported macrovascular and microvascular complications, respectively. Nonfatal myocardial infarction (40.0%) and neuropathy (82.0%) were the most common complications. At baseline and 3-years, 25.1% (1119/4466) and 36.6% (1356/3700) of participants had HbA1c <7%, respectively. At 3-years, population with macrovascular and microvascular complications had higher proportion of participants with uncontrolled glycemia (78.2% [79/101] and 70.3% [463/659], respectively) than those without complications (61.6% [1839/2985]). Over 3-years, majority (67.7%-73.9%) of the participants were taking only OADs (biguanides [92.2%], sulfonylureas [77.2%] and DPP-IV inhibitors [62.4%]). Addition of insulin was preferred in participants who were only on OADs at baseline, and insulin use gradually increased from 25.5% to 36.7% at the end of 3 years. CONCLUSION: These 3-year trends highlight the burden of uncontrolled glycemia and cumulative diabetes-related complications, emphasizing the importance of optimizing diabetes management in India.

Diagnosis of gestational diabetes mellitus in the community.

BACKGROUND AND OBJECTIVE: Diabetes in Pregnancy Study Group India (DIPSI) recommends 2-h Plasma glucose (PG) > or = 140 mg/dL with 75g oral glucose load to diagnose GDM, akin to WHO criteria. Recently, International Association of Diabetes in Pregnancy Study Group (IADPSG) recommends any one value of Fasting plasma glucose (FPG) > or = 92 mg/ dL, 1-h PG > or = 180 mg/dL or 2-h PG > or = 153 mg/dL to diagnose GDM. The objective of this study was to find out whether DIPSI guidelines could still be continued to diagnose GDM in our country, as this requires one blood test compared to three tests of IADPSG, which is expensive. METHOD: Consecutive pregnant women (N = 1463) underwent 75g oral glucose tolerance test (OGTT). The proportion of GDM was computed based on IADPSG and DIPSI criteria and the discordant pair of diagnosing GDM was examined by McNemar test. Analysis was two tailed and P-value <0.05 was considered for statistical significance. RESULT: The prevalence of GDM was 14.6% (N = 214) by IADPSG criteria and 13.4% (n = 196) by DIPSI criteria. The discordant pair between the two criteria examined by McNemar's test indicated that there was no statistical significance (P = 0.21) and thereby implying a close agreement between these two procedures. CONCLUSION: DIPSI procedure is cost-effective, without compromising the clinical equipoise and can be continued to diagnose GDM in our country, as well as other less resource countries.

Maintenance of glycaemic control with the evening administration of a long acting sulphonylurea in male type 2 diabetic patients undertaking the Ramadan fast.

BACKGROUND: In Ramadan, misuse of hypoglycaemic agents, alterations in diet and hypoglycaemia are frequent. This study assessed whether switching to an evening administration of a long acting sulphonylurea during the 29-day, dawn to dusk fast, can maintain glycaemic control in patients with type 2 diabetes. PATIENTS AND METHODS: Male type 2 diabetic patients from Bangladesh, Pakistan and India, under glycaemic control with gliclazide modified release (MR) 60 mg monotherapy, switched to evening administration of the same dose during Ramadan, and reverted to the morning schedule thereafter. The primary outcome was the difference in fasting plasma glucose (FPG) before and after Ramadan. RESULTS: In 136 patients, mean (95% CI) FPG decreased by 0.01 mmol/l (0-0.2, p = 0.3) with evening medication by the end of the fast, and increased by 0.2 mmol/l (0.1-0.3, p = 0.01) after reverting to morning medication 20 days later. There were 5 (3.7%) hypoglycaemic episodes before, 3 (2.2%) during and 2 (1.5%) after Ramadan. CONCLUSION: Male type 2 diabetic patients undertaking the Ramadan fast can safely maintain glycaemic control with evening administration of gliclazide MR 60 mg during the fast, and reverting to a morning schedule thereafter.

Causes of mortality in diabetes mellitus: data from a tertiary teaching hospital in India.

BACKGROUND: Mortality studies can show the relative contribution of diabetes to mortality in the total population, and they can provide important descriptions of the changes in causes and frequency of diabetes mortality over time. OBJECTIVE: To find the mortality pattern in people with diabetes admitted to a tertiary care hospital in a developing country, using underlying/contributory causes of death. METHODS: In this retrospective study, mortality trends among people with diabetes admitted to Sher-i-Kashmir Institute of Medical Sciences, Srinagar, Kashmir, India were reviewed by screening the hospital records of all people with diabetes who died over the last 9 years, carrying forward earlier observations from the same centre. RESULTS: Of 234 776 people admitted to the centre during the review period, 16 690 (7.11%) died; 741 (383 men) of these had diabetes mellitus mentioned on the death certificate. The mean (SD) age at death for people with diabetes was 60.07 (13.62) years in men and 57.36 (13.40) years in women. The leading contributory causes of death were infections (40.9%), chronic renal failure (33.6%), coronary artery disease (16.9%), cerebrovascular disease (13.2%), chronic obstructive pulmonary disease (6.9%), acute renal failure (6.2%), malignancy (4.2%), hypoglycaemia (3.5%) and diabetic ketoacidosis (3.4%). The cause of death could not be ascertained in 2.8% of cases; in 52.9%, 36.3% and 8.0% cases one, two and three or more causes, respectively, were recorded as the cause of death. CONCLUSIONS: The aetiological spectrum of mortality in people with diabetes at this Indian centre continues to be dominated by infections and renal failure, which is different from that in the developed world, where coronary artery disease and cerebrovascular disease are the principal causes of death in people with diabetes.

Vitamin D status in apparently healthy adults in Kashmir Valley of Indian subcontinent.

BACKGROUND: The worldwide prevalence of vitamin D deficiency is reported to be high. OBJECTIVES: To assess the vitamin D status in apparently healthy adults in Kashmir valley by measuring serum 25-hydroxyvitamin D (25 (OH) D). METHODS: 92 healthy natives (64 men and 28 non-pregnant/non-lactating women, aged 18-40 years), residing in Kashmir for at least last 5 years and not having any suggestion of systemic disease, were selected for this study. The samples were collected throughout the year in both summer and winter months. Vitamin D deficiency was defined as a serum 25 (OH) D concentration of <50 nmol/l and graded as mild (25-50 nmol/l), moderate (12.5-25 nmol/l) and severe (<12.5 nmol/l). RESULTS: Body mass index, total energy intake, and other nutritional parameters were comparable among subjects in different groups. Overall 76 (83%) of the subjects studied had vitamin D deficiency--25%, 33%, and 25% had mild, moderate, and severe deficiency, respectively. 49 of the 64 males and all but 1 of the 28 females were vitamin D deficient. The prevalence of vitamin D deficiency ranged from 69.6% in the employed group to 100% in the household group. Vitamin D deficiency was equally prevalent in subjects from rural and urban areas. Serum calcium and phosphorus values were comparable in subjects with and without vitamin D deficiency, while daily intake and urinary excretion of calcium were significantly lower in the former. Vitamin D deficient subjects had a significantly lower mean weekly exposure to sunlight. CONCLUSIONS: In spite of abundant sunlight, healthy individuals in Kashmir valley are vitamin D deficient, particularly women. Serum 25 (OH) D concentrations are significantly related to sun exposure.

Clinical practice points for diabetes management during RAMADAN fast.

Diabetes management during Ramadan is very crucial from the patient perspective as it can present significant risk of hypoglycemia and death when proper care is not taken. Moreover, managing diabetes in fasting Ramadan patients require different mechanisms than the routine diabetes management and pose significant challenge to the health care practitioners. Here we set forth to review the available literature of various clinical trials and studies on different antidiabetic agents in the context of Ramadan. On the basis of available evidence, we suggest that gliclazide is effective and it could be safely recommended in type 2 diabetic patients fasting during Ramadan.

Clinical and etiological profile of hyperprolactinemia--data from a tertiary care centre.

OBJECTIVE: To study the clinical presentation and etiology of hyperprolactinemia, a common disorder encountered in endocrine practice. METHODS: We analyzed the clinical data, hormone profile and imaging reports of 187 females with documented hyperprolactinemia, over a period of 6 years (5 years retrospective analysis and one year prospective study). RESULTS: Majority of the 187 subjects studied presented in 3rd or 4th decade. Galactorrhoea was the commonest presenting symptom occurring in 159 subjects (85%), followed by amenorrhea in 68.9%; both amenorrhea and galactorrhea were seen in 45.4%. A microprolactinoma was demonstrated in 67 patients (35.8%), a nonfunctioning pituitary macroadenoma with stalk hyperprolactinemia occurred in 30 patients (16%) and polycystic ovarian disease was documented in 24 (12.8%). In 52 patients (27.8%) no apparent cause could be ascertained. CONCLUSIONS: Syndrome of amenorrhea and/or galactorrhea is the commonest presentation in hyperprolactinemia. Microprolactinoma was the most frequent identifiable etiology followed by idiopathic and stalk hyperprolactinemia in our series.

Epidemiologic and etiologic aspects of primary infertility in the Kashmir region of India.

OBJECTIVE: To assess the magnitude of primary infertility and to study its etiologic aspects in India. DESIGN: After proper randomization, 10,063 married couples were interviewed to ascertain the prevalence of primary infertility. A definitive protocol was followed to determine the etiology of primary infertility in 250 consecutive couples. SETTING: Tertiary care medical center in the Kashmir valley of India. PATIENT(S): Couples married for > or = 1 year; 250 consecutive couples attending an endocrine clinic for primary infertility. INTERVENTION(S): A logical investigative protocol was followed to identify the etiology of infertility. MAIN OUTCOME MEASURE(S): Magnitude of primary infertility in the community as well as the male, female, or combined etiology of infertility. RESULT(S): Fifteen percent of the couples interviewed had primary infertility, among whom 4.66% had unresolved infertility at the time of the survey. The etiology of infertility in 250 consecutive couples revealed a female factor in 57.6%, a male factor in 22.4%, combined factors in 5.2%, and an undetermined cause in 14.8%. CONCLUSION(S): Primary infertility is as common and distressing a problem in India as in other parts of the world. Semen abnormalities (22.4%), anovulation (17.2%), ovarian failure (8.8%), hyperprolactinemia (8.4%) and tubal disease (7.2%) are common causes of infertility. The pattern of infertility in India is the same as in other parts of the world, except that infertile couples report late for evaluation.

Puerperal alactogenesis with normal prolactin dynamics: is prolactin resistance the cause?

OBJECTIVE: To determine the cause of puerperal alactogenesis in a young woman. DESIGN: After proper clinical assessment, a definitive investigative protocol was followed to determine the cause of alactogenesis. SETTING: Tertiary care medical center in Kashmir, India. PATIENT(S): A young married woman with three full-term deliveries, all characterized by puerperal alactogenesis. INTERVENTION(S): An investigative protocol to document prolactin reserve and mammography to demonstrate presence of normal breast tissue. MAIN OUTCOME MEASURE(S): Prolactin secretory reserve. RESULT(S): The patient had normal breast development and an adequate pituitary prolactin reserve. CONCLUSION(S): Prolactin resistance may have caused alactogenesis.

Mortality in diabetes mellitus--data from a developing region of the world.

This retrospective study presents the mortality trends in diabetic patients in a developing region of the world. The data were collected by screening the hospital records of all diabetic patients who died over a period of a decade at Institute of Medical Sciences, a tertiary care medical centre in Kashmir Valley of India. Of 133,374 patients admitted to the centre from January 1987 to December 1996, 9627 died, of whom 269 (151 males and 118 females) were recorded to have diabetes mellitus. The mean+/-S.D. age at the time of death was 51.61+/-13.77 years for males and 51.50+/-15.50 years for females. The common causes contributing to death were infections (33.83%), chronic renal failure (30.85%), coronary artery disease (16.36%), cerebrovascular disease (13.75%), hypoglycaemia (7.81%), diabetic ketoacidosis (6.69%) and hyperosmolar coma (2.23%). In 7.43% patients the cause of death could not be ascertained. Death was attributed to single cause in 60.22%, to two causes in 26.39% and to three or more causes in 5.95%. Most (59.11%) of these diabetic patients died within a week of hospitalisation. We conclude that mortality trends in diabetes mellitus differ in developing regions as compared to developed regions reflecting poor healthcare in general and diabetic care in particular. Unlike in west, where the major killers in diabetic patients are coronary artery disease and cerebrovascular disease, infections and chronic renal failure continue to be leading causes of death in patients with diabetes mellitus in developing regions like ours.

Impaired fasting glucose and impaired glucose tolerance - lack of agreement between the two categories in a North Indian population.

This study was carried out to determine the relationship between impaired fasting glucose (IFG) and impaired glucose tolerance (IGT) in a North Indian population. The data in 5083 subjects studied earlier was reanalyzed by applying new WHO diagnostic criteria. Reanalysis revealed that 305 (6.0%) subjects had diabetes mellitus (198 on the basis of fasting plasma glucose of > or =7.0 mmol/l (> or =126 mg/dl) and an additional 107 based on a 2-h glucose tolerance test), 381 (7.5%) had IFG and 361 (7.1%) had IGT. Of these 361 subjects with IGT, only 99 (27.4%) had impaired fasting glucose whereas 262 (72.6%) had normal fasting glucose of <6.1 mmol/l (<110 mg/dl). Of 381 subjects with IFG, 99 (26%) had IGT where as 282 (74%) had normal 2-hr glucose. We conclude that there is a poor correlation between IGT and IFG.

Prevalence of type 2 diabetes mellitus and impaired glucose tolerance in the Kashmir Valley of the Indian subcontinent.

This cross-sectional population survey was undertaken to determine the prevalence of type 2 diabetes and impaired glucose tolerance in subjects aged 40 years or more in Kashmir Valley, India. The study was carried out in two phases. In phase one, 6091 randomly selected subjects, 40 years or older, from all six districts of the valley were surveyed for prevalence of known diabetes mellitus. In phase two, 5083 subjects, 40 years or older, were screened with oral glucose tolerance test for prevalence of undiagnosed (asymptomatic) diabetes mellitus and impaired glucose tolerance. Abnormalities of carbohydrate intolerance were determined as recommended by WHO. Of 6091 subjects interviewed, 115 were known cases of diabetes mellitus with an overall prevalence of 1.89% (1.98% in males and 1.77% in females). Results of glucose tolerance test revealed that mean fasting as well as mean 2 h blood glucose was significantly more in females as compared to males (4.68+/-0.91 and 6.40+/-2.12 vs. 4.49+/-0.96 and 5.94+/-2.03 mmol/l, respectively, P < 0.0001). Of 5083 subjects who were subjected to glucose tolerance test (GTT), 627 (12.34%) had an abnormal test; with 411 (8.09%) having impaired glucose tolerance (IGT) and 216 (4.25%) having diabetes mellitus. The prevalence of IGT as well as of diabetes was significantly more in females as compared to males (P < 0.001). Subjects who had family history of diabetes had a significantly higher prevalence of abnormal GTT. Prevalence of known diabetes as well as that of abnormal GTT steadily increased with age, with a highest prevalence in the age group of > or = 70 years (P < 0.001). Obese subjects had a significantly higher basal as well as 2 h blood glucose in males as well as in females. Subjects with diabetes on GTT had a higher waist/hip ratio. Overall the prevalence of diabetes as well as IGT was significantly higher in the urban population. We conclude that 1.89% of the general population have known diabetes, 4.25% have undiagnosed diabetes and 8.09% have impaired glucose tolerance test; making the total load of abnormal glucose tolerance 14.23% in Kashmir Valley. In subjects greater than 40 years of age having a family history of diabetes, obesity, higher age (50 years or above), female sex, and urban origin have more chance (odds ratio: 4.65, 2.30, 1.87, 1.49 and 1.16, respectively) of developing abnormal glucose tolerance.

The burden of diabetes and impaired fasting glucose in India using the ADA 1997 criteria: prevalence of diabetes in India study (PODIS).

This random multistage cross sectional population survey was undertaken to determine the prevalence of diabetes mellitus (DM) and impaired fasting glycemia/glucose (IFG) in subjects aged 25 years and above in India. The study was carried out in 108 centers (49 urban and 59 rural) to reflect the size and heterogeneity of the Indian population. 41,270 (20,534 males and 20,736 females) subjects were studied. 21,516 (10,865 males and 10,651 females) were from urban areas and 19,754 (9669 males and 10,085 females) from rural areas. Blood samples were taken after a fast of 10-12h and the subjects were categorized as having IFG or DM using the 1997 American Diabetes Association criteria. The age and gender standardized prevalence rate for DM and IFG in the total Indian population was 3.3 and 3.6% respectively (P < 0.001). The standardized prevalence of DM and IFG in urban areas was significantly higher than that for the rural population (urban DM prevalence 4.6% versus rural DM prevalence 1.9%, P < 0.001; urban IFG prevalence 4.8% versus rural IFG prevalence 2.5%, P < 0.001). There was no statistically significant difference in the prevalence between DM (4.6%) and IFG (4.8%) in the urban population. The rural prevalence of IFG (2.5%) was significantly (P <0.001) more than the rural prevalence of DM (1.9%). Type 2 diabetes is a major health problem is India.

Comparing the ADA 1997 and the WHO 1999 criteria: Prevalence of Diabetes in India Study.

This random multistage cross-sectional population survey was undertaken to determine the prevalence of type 2 diabetes mellitus (DM) in subjects aged 25 years and above in India. The study was carried out in 77 centres (42 urban and 35 rural) to reflect the size and heterogeneity of the Indian population. 18,363 (9008 male and 9355 female) subjects were studied. 10,617 (5379 males and 5238 females) were from urban areas and 7746 (3629 males and 4117 females) from rural areas. Blood samples were taken after a fast of 10-12 and 2 h after 75 g of oral glucose. Subjects were categorized as having impaired fasting glycemia (IFG) or DM using the 1997 ADA or having impaired glucose tolerance (IGT) or DM using the 1999 WHO criteria. The age- and gender-standardized prevalence rate for DM using the ADA criteria was 3.6% whilst that using the WHO criteria was 4.3% (P < 0.001). The respective standardized prevalence of DM, using the two criteria was, 4.7 and 5.6%, respectively (P < 0.001) in the urban Indian population and 2.0 and 2.7% (P < 0.02) in the rural Indian population. Using the WHO criteria, 581 subjects were newly diagnosed whilst the ADA criteria newly diagnosed 437 subjects. The respective numbers for the urban population were 425 and 323, and for the rural population were 146 and 114, respectively. The ADA criteria could diagnose 75.2, 76.0 and 73.0% of the subjects who had DM as per the WHO criteria. Of 739 Indian subjects who had IFG, 106 (14.3%) were diagnosed as having DM by the WHO criteria whilst 505 (68.3%) had values compatible with a diagnosis of IGT. Of the 536 urban subjects with IFG, 74 (13.8%) had DM and 350 (65.3%) had IGT using the WHO criteria. Of the 302 rural subjects with IFG, 32 (15.8%) had DM and 155 (76.3%) had IGT using the WHO criteria. 505 (49.9%) of 1012 Indian subjects with IGT as per the WHO criteria had IFG. 350 (47.7%) of 733 urban subjects and 155 (55.5%) of 279 rural subjects with IGT had values compatible with IFG as per the ADA criteria. Type 2 diabetes is a major health problem is India. The use of the ADA criteria would underestimate the prevalence of DM by not diagnosing subjects showing a poor response to a glucose challenge. This along with the discrepancies between subjects showing IGF or IGT could be a challenge to any prevention program.

The burden of diabetes and impaired glucose tolerance in India using the WHO 1999 criteria: prevalence of diabetes in India study (PODIS).

This random multistage cross-sectional population survey was undertaken to determine the prevalence of diabetes mellitus (DM) and impaired glucose tolerance (IGT) in subjects aged 25 years and above in India. The study was carried out in 77 centers (40 urban and 37 rural). 18363 (9008 males and 9355 females) subjects were studied. 10617 (5379 males and 5238 females) were from urban areas and 7746 (3629 males and 4117 females) from rural areas. Blood samples were taken after a fast of 10-12 h and 2 h after 75 g of oral glucose. Subjects were categorized as having IGT or DM using the World Health Organisation (WHO) (1999) criteria. The standardized prevalence rate for DM in the total Indian, urban and rural populations was 4.3, 5.9 and 2.7%, respectively. The corresponding IGT rates in the three populations was 5.2, 6.3 and 3.7%, respectively. The urban prevalence of DM and IGT was significantly greater than in the rural population (P < 0.001 in both instances). The prevalence of DM was significantly, more than that of IGT (P < 0.001) within both the rural and urban populations. Type 2 diabetes is a major health problem is India.

Copper, zinc and magnesium levels in fibrocalculous pancreatic diabetes.

Alterations in trace elements and mineral homeostasis have been documented both in insulin-dependent diabetes mellitus and non-insulin dependent diabetes mellitus. No data are available about trace elements in fibrocalculous pancreatic diabetes, a unique form of secondary diabetes mellitus. This study evaluated the plasma concentrations of copper, zinc and magnesium in this form of diabetes. Twenty-five patients (9 men and 16 women) with fibrocalculous pancreatic diabetes and 25 healthy non-diabetic subjects (16 men and 9 women) were studied. Patients with overt nephropathy were excluded. Plasma copper, zinc, and magnesium levels were analyzed using a GBC 902 double beam absorption spectrophotometer. The effect of glycemic control, microalbuminuria, sex and modality of treatment received on the plasma levels of copper, zinc and magnesium was assessed. Results of the study revealed that plasma copper, zinc, and magnesium levels were comparable between patients with fibrocalculous pancreatic diabetes and control subjects. Plasma copper levels were significantly higher in patients with controlled diabetes (16.15 +/- 0.67 micromol L(-1)) as compared to those with uncontrolled diabetes (13.75 +/- 0.61 micromol L(-1)) and healthy controls (13.91 +/- 0.55 micromol L(-1)). This merits further investigation. Microalbuminuria, modality of treatment received and sex did not influence the levels of these elements in fibrocalculous pancreatic diabetes.

Postpartum thyroiditis in India: prevalence of postpartum thyroiditis in Kashmir Valley of Indian sub-continent.

Various studies have reported a spectrum of thyroid dysfunction in the postpartum period. Postpartum thyroiditis is a syndrome of thyroid dysfunction that occurs in the first year after parturition. Prevalence of postpartum thyroiditis has been reported to vary from 3 to 6 percent in different regions of the world. Kashmir Valley is inhabited by a relatively homogeneous racial group and the Valley has been documented to have significant iodine deficiency. We studied the prevalence and pattern of postpartum thyroiditis in an urban region of this Valley. 120 women were registered within first month of postpartum period for the study along with one hundred controls. Of these 120 women, 104 reported for follow-up at 3 months postpartum and 106 reported for follow-up at 6 months postpartum. Initial and subsequent clinical details at follow-up were recorded on a pre-determined questionnaire. Overall, postpartum thyroiditis (PPT) was seen in 8 (7%) study subjects. Of these 8 patients with PPT, 4 had biochemical evidence of thyrotoxicosis at first month, 3 developed biochemical thyrotoxicosis at 3-month follow-up while as one study subject developed thyrotoxicosis at 6 months. Most of these subjects were antithyroid antibodies (anti-microsomal and anti-thyroglobulin) positive. We conclude that iodine deficient status of the community doesn't seem to influence the incidence of PPT.

Response of regimens of insulin therapy in type 2 diabetes mellitus subjects with secondary failure.

OBJECTIVE: To find the response of various regimen of combination therapy (Insulin and Glibenclamide) in type 2 diabetes mellitus subjects who failed to respond to maximum doses of glibenclamide (GBC) plus phenformin. METHODS: A total of 188 subjects with secondary sulfonylurea failure who failed to respond to maximum doses of GBC and phenformin were randomised to receive one of the four regimens. Group A (50 patients) received two doses of insulin; Group B (49 patients) received two doses of insulin and GBC 20 mg/day; Group C (43 patients) received morning dose of insulin with GBC 20 mg/day; and Group D (46 patients) received evening dose of insulin with GBC 20 mg/day. Insulin dose was adjusted to achieve an acceptable blood glucose control. Control of diabetes was revaluated at three months post-treatment period. RESULTS: Age, duration of diabetes, weight, body mass index (BMI) and biochemical parameters were comparable in all four groups at admission. Dose of insulin was 0.83 +/- 0.07, 0.86 +/- 0.06, 0.46 +/- 0.04 and 0.39 +/- 0.03 units/Kg/day in groups A, B, C and D, respectively. Comparing groups A and B, we found that the dose of insulin (IU/kg/day) required to achieve acceptable fasting blood glucose (FBG) did not differ significantly. Similarly, comparison between Groups C and D did not reveal any significant difference in insulin dose. Mean hospital stay required to achieve an acceptable FBG was 8.42 +/- 0.34, 11.95 +/- 1.11, 8.59 +/- 0.61 and 7.10 +/- 0.48 days in groups A, B, C and D, respectively (p = 0.013). On comparing the four treatment regimens, at three months follow-up, there was a significant increase in bodyweight in Group C; also there was an increase in fasting blood glucose in all the groups except in Group D. CONCLUSIONS: Continuation of GBC in type 2 diabetes mellitus subjects who fail to respond to maximum doses of GBC plus phenformin and who need two doses of insulin for control has no added advantage over giving insulin alone. In subjects controlled on a single dose of insulin with glibenclamide it is preferable to give an evening dose rather than a morning dose.

Regular ovulatory menstrual cycles in a case of Sheehan's syndrome.

In this report we describe an unusual case of postpartum pituitary necrosis who had clinical and biochemical suggestion of decreased thyrotroph, somatotroph, lactotroph, and corticotroph reserve but continued to have regular ovulatory menstrual cycles.