Adoption of Gla-100 in India and its Impact on Insulin Usage Patterns.

Fueled by perceptions regarding Indian dietary patterns and premixed insulin's claim to fame of providing dual fasting and post-prandial control, there was a greater inclination towards using premixed insulins in clinical practice until the last decade. However, the advent of insulin glargine 100 U/mL (Gla-100) opened up a new dimension in insulin therapy landscape in India. The data from the last 5 years reveal that Gla-100 has gained more traction among Indian clinical practitioners. Basis evidences that have emerged from various clinical studies, this present review elaborates on certain key issues which have helped Gla-100 carve its own niche and effected a progressive shift in insulin prescription pattern in India.

Adherence and Swallowing Experience with a Modified, Smaller-sized Tablet Formulation of Metformin and Glimepiride (SR) in Indian Patients with Type 2 Diabetes Mellitus.

BACKGROUND: This study evaluated the adherence and swallowing experience with novel oval-shaped, compact-sized metformin (500 mg/1000 mg)-glimepiride (1mg/2mg) combination, sustained-release tablet (Gluformin G1/Gluformin G2 SR; GM-new-SR) in Indian patients with T2DM, previously treated with conventional metformin-glimepiride combination tablet. METHODS: Patients' adherence, swallowing experience, and satisfaction were assessed at baseline and month-3 by Adherence to Refills and Medication Scale (ARMS12; adherent: ARMS12 score=12; nonadherent: ARMS12 score >12) and questionnaire based 5-point Likert scale, respectively. Safety was also assessed. RESULTS: Of 1550 patients enrolled, 1547 (99.8%) completed the study. After 3 months of switching to GM-new-SR tablets, adherence rate increased from 4.38% to 91.1%, with concurrent reduction in mean ARMS-12 score by 6.3±4.36 (p<0.0001). Compared to baseline, all glycemic indices, HbA1c, PPG, and FPG, significantly improved (p<0.0001) in the overall population. Reduction in HbA1c levels was significant only in patients who were adherent to therapy as opposed to nonadherent patients (7.8±1.74 to 7.1±0.85, p<0.0001 vs. 7.7±1.39 to 6.7±0.77, p=0.4276). Most patients attributed ease of swallowing of GM-new-SR tablets to its modified shape (95.5%) and size (94.9%). Most patients (90.4%) were satisfied with the new tablet formulation. Size of the tablet was the most common reason for patients' nonadherence with conventional tablets, which was reported to be less frequent with GM-new-SR tablets (2.5% vs 53.4%). CONCLUSION: Treatment with GM-new-SR tablets significantly increased adherence and was associated with improvement in glycemic indices, which could be attributed to the compact shape and size of the new tablet formulation.

Review of Clinical Profile of IDegAsp.

In patients with diabetes, treatment intensification requires basal and bolus insulin injections to control the fasting and prandial insulin needs. To overcome the burden of multiple daily injections, co-formulating basal and bolus insulins in single injection could allow a simple regimen with fewer injections. Current premixed insulin analogues are limited by the protaminated insulin component, which cannot provide effective basal coverage. While, long-acting insulin analogues like insulin glargine and insulin detemir cannot be combined with rapid-acting insulin analogues due to physicochemical incompatibility. Insulin degludec/insulin aspart (IDegAsp) is a soluble co-formulation of two distinct insulin analogues in the ratio of 70% ultra-long-acting insulin degludec (IDeg) and 30% rapid-acting insulin aspart (IAsp). The distinct PK/PD properties of IDeg and IAsp components are preserved in the co-formulation, with the rapid absorption characteristics of IAsp and flat and stable profile of IDeg maintained separately. Size exclusion chromatography studies of IDegAsp indicate that IDeg and lAsp exist as stable di-hexamers and hexamers, respectively in the formulation. Moreover, at steady state, the prandial and basal glucose lowering effects of IDeg and IAsp were distinct and clearly separated. A clear dose-response relationship was observed in patients with type 1 and type 2 diabetes treated with IDegAsp. The glucose lowering effects of basal and prandial components of IDegAsp are maintained in elderly (≥ 65 years of age) patients with type 1 diabetes. In addition, the PK and clearance of IDeg and IAsp are not affected by mild, moderate or severe renal or hepatic impairment. Presence of two distinct insulin analogues, as a soluble co-formulation with basal component with an ultra-long duration of action makes IDegAsp an advance to premix insulins.

Study of prevalence of nonalcoholic fatty liver disease (NAFLD) in type 2 diabetes patients in India (SPRINT).

Non-alcoholic fatty liver disease (NAFLD) is a distinct hepatic condition and one of the most common causes of chronic liver disease globally. Prevalence of the disease is estimated to be around 9-32% in the general Indian population, with a higher incidence rate amongst obese and diabetic patients. We conducted this study to determine frequency and risk factors of NAFLD in nonalcoholic Indian type 2 diabetic (T2DM) patients, based on elevated aminotransferase levels, defined as per NHANES III criteria. Out of 924 patients (355 female/569 male), in age group of 25-84 years, enrolled at 189 centers across 101 cities in India, a cohort of 522(56.5%) T2DM patients were identified as having NAFLD. Prevalence of the disease was found to be higher in females (60%) than in males (54.3%) T2DM patients; with prevalence of NAFLD varying from 44.1% in western India to 72.4% in northern states. In our study the prevalence of NAFLD increased with increasing age, with 239(45.8%) identified patients in age group of 25-50 years and 283(54.2%) among those aged 51 years (OR:0.71, 95%CI: 0.54-0.92, p=0.005); with highest prevalence recorded in 61-70 year age group, at 61.8%. The results from the study reinforced the well established clinical association of NAFLD with elements of metabolic syndrome (MetS) including dyslipidemia, hypertension and obesity; as T2DM population with these co-morbid conditions had 38%, 17% and 14% higher risk respectively, for NAFLD. The mean AST and ALT levels were 54.8+/-36.1 IU/L and 55.6+/-39.8 IU/L, respectively in NAFLD population and highest in age group of 25-40 years and lowest in 71-84 years age group. Mean ALT levels were found to be higher than mean AST levels across all age groups in identified T2DM NAFLD cohort, with 340(65.3%) patients having elevation of both AST and ALT levels. The results from this study besides demonstrating the prevalence pattern of NAFLD and associated risk factors in Indian T2DM patients, also point out that even mild elevation in aminotransferase levels warrants attention, since it might more often than not point to previously unsuspected liver disease.

Study of Non-Thyroidal Illness Syndrome and Its Recovery in Critically Ill Patients at a Tertiary Care Centre in South India.

Background and Objectives: Transient thyroid hormone alterations are common during critical illness and are termed non-thyroidal illness syndrome (NTIS). We studied the prevalence of NTIS in the ICU setting and its impact on predicting mortality and other outcomes and compared it to the Acute Physiology and Chronic Health Evaluation II (APACHE II) score. Materials and Methods: The study included 119 consecutive patients admitted with a critical illness. APACHE II score was calculated. Total T3, total T4, TSH, free T3, and free T4 were measured at admission and after six weeks of discharge. NTIS and euthyroid groups were studied for ICU, hospital stays, mortality, readmission, and recovery. Predictors of mortality were compared between survivors and non-survivors. Results: The mean age was 60.15 ± 14.50 years with M:F = 84 (71%):35 (29%). NTIS was observed in 84 (71%), low T3 being the most common abnormality in 53 (63%). The occurrence of NTIS was significantly higher among non-survivors (28/30, 93%) versus survivors (56/89, 63%) (P = 0.002). Non-survivors showed significantly lower T3, TSH, and FT3/FT4 ratios and higher readmissions. NTIS group showed significantly greater ICU stay (P = 0.02) and had higher readmission rates (P = 0.032). Baseline T3 had the greatest power to predict mortality. APACHE II score also correlated significantly with mortality (19.60 ± 10.58 vs 11.99 ± 6.80, P < 0.001). The area under the curve (0.677) for the T3 level was lower than the APACHE II score (0.760). After six weeks, 61% had recovered from NTIS. Conclusions: NTIS was common amongst critically ill patients (71.5%), which reversed in 61% at six weeks. Low T3 was the most common abnormality and independently predicted mortality. Free T3/free T4 also significantly predicted mortality. The correlation between thyroid dysfunction and the severity of primary illness makes it an additional attractive low-cost marker of mortality.

One-year safety and effectiveness of insulin degludec in patients with diabetes mellitus in routine clinical practice in India-TRUST (Tresiba real-world use study).

Objective: This post-authorization safety study (PASS) was conducted to evaluate the long-term safety and effectiveness of insulin degludec in patients with diabetes mellitus (DM) requiring insulin therapy in routine clinical practice in India. Methods: Data on glycated hemoglobin (HbA1c) and adverse events (AEs) were collected up to 12 months after insulin degludec initiation. Results: A total of 1057 adult patients with DM were enrolled, including 60.07% males with the mean duration of 22.2 ± 21.90 years with type 1 DM and 10.1 ± 7.37 years with type 2 DM and the mean HbA1c of 9.6 ± 1.9%. Insulin degludec was prescribed to improve HbA1c and fasting plasma glucose (FPG). Insulin degludec daily dose was increased from 14.8 ± 8.0 U to 18.0 ± 9.46 U over 12 months resulting in a significant decrease of HbA1c by 1.8 ± 1.68% compared with baseline. There were 84 events of confirmed hypoglycemia in 51 patients during the 12-month follow-up period, and 44 AEs were reported in 2.6% of patients, of which 2 AEs were serious and unrelated to the drug. Conclusion: Insulin degludec is well tolerated in patients with DM. It improves glycemic control with reduced HbA1c, FPG, and postprandial glucose, with a low risk of hypoglycemia.

Real-World Observational Study of Glimepiride and Metformin Fixed-Dose Combination Along With Insulin in the Management of Type 2 Diabetes Mellitus: Indian Experience.

Background Type 2 diabetes mellitus (T2DM) is associated with a significant burden on both patients and the healthcare system. This study aimed to evaluate the demographics of patients with T2DM receiving different strengths of glimepiride and metformin combination along with insulin. This study also examined the concomitant conditions and therapies, duration of therapies, dosage titration, glycated hemoglobin (HbA1c) levels, hypoglycemic events, and weight changes during the course of therapy. Methods This retrospective, multicenter (347), observational study included adult patients with T2DM who received glimepiride and metformin combination along with insulin. Data related to demographic characteristics, duration of disease, co-morbidities, concomitant medications, and dosage pattern was collected from medical records authenticated by physicians during routine care. Results A total of 7058 patients were included in the study. The median age of included patients was 55 years and around 29% were aged >60 years and 60% were men. The majority of patients (83.3%) had insulin treatment initiation after glimepiride and metformin combination while other patients (16.7%) received glimepiride and metformin combination after insulin initiation. The mean HbA1c levels significantly decreased with a mean change of 1.33%. In one-third of the patients, down-titration of the insulin dose was done, indicating the insulin-sparing effect with the addition of the glimepiride and metformin combination. The most common comorbid condition was hypertension (64.7%). Of 3705 patients, 33.2% patients had weight loss and 66.8% had weight gain. A total of 432 patients reported hypoglycemic events. Physician global evaluation of efficacy and tolerability showed a good to excellent on the scale (97.3% and 96.6%). Conclusion This study presented good HbA1c lowering with glimepiride and metformin combination with insulin, ensuring a positive clinical outcome. Good to excellent efficacy and tolerability were observed in patients with T2DM across the age groups, in early as well as long-standing disease.

Persistent Elevation of Parathormone Levels after Surgery for Primary Hyperparathyroidism.

BACKGROUND: Persistent elevation of serum parathyroid hormone (PTH) despite normocalcemia have been documented in 8- 40% of patients after parathyroidectomy. We hereby report our experience from different centers across India to determine clinical significance of postoperatively elevated PTH levels and review relevant literature. METHODS: We conducted a retrospective case series study and reviewed all the patients who underwent surgery for primary hyperparathyroidism (PHPT) from April 2010 to January 2020. RESULTS: Total of 201 patients was diagnosed as PHPT. Out of available follow-up data of 180 patients, a total of 54 patients (30%) had persistently elevated PTH (PePTH) at 1 month. Patients with PePTH were older with higher preoperative serum calcium, iPTH, alkaline phosphatase and lower serum phosphate and 25-hydroxy vitamin D3 levels. Creatinine clearance was found to be significantly lower in patients with PePTH. Multiple linear regression analysis revealed that preoperative 25-OH D3 concentration, creatinine clearance and iPTH are the factors influencing persistent elevation of PTH levels. Significantly lower serum calcium and higher alkaline phosphatase levels were observed in PePTH patients with preoperative 25-OH D3 levels <20 ng/mL. Thirty patients at 6 months, 24 patients at 1 year, 18 patients at 2 years and 9 patients at 3 years had eucalcemic PTH elevation. Nine out of 126 (7%) patients with normal initial postoperative calcium and iPTH levels developed PePTH, with none culminating into recurrent hyperparathyroidism. CONCLUSION: Though the pathogenesis of such a phenomenon still remains to be elucidated, a multifactorial mechanism appears to play a role.

Utility of colour Doppler sonography in patients with Graves' disease.

OBJECTIVE: Assessment of thyroid blood flow gives valuable information about underlying functional status. Colour Flow Doppler Sonography (CFDS) is a powerful tool which displays tissue blood flow and vascularity. Colour Flow Doppler Sonography of the thyroid gland in different subsets of patients with Graves' disease was studied to define its role in initial diagnosis and management. METHODS: Eighty consecutive patients with Graves' disease (both treated and untreated) presented to hospital between August 2007 and February 2008. All patients were evaluated with CFDS of the thyroid for size, vascularity and peak systolic velocity (PSV) of the Inferior Thyroid Artery (ITA). Pertechnate scan and thyroidal autoantibody levels were done in selected cases. The patients were divided into Untreated Graves' disease (n = 31), Graves' disease on treatment but hyperthyroid (n = 26) and euthyroid Graves' disease on therapy (n = 23). Mann-Whitney U-test was used for statistical analysis and a p-value of less than 0.05 was considered significant. RESULTS: Thyroid blood flow, as assessed by PSV of ITA, was significantly higher in untreated Graves' disease than in Graves disease on treatment but hyperthyroid and euthyroid Graves respectively (61.5 +/- 19.5 versus 42.9 +/- 24.7 versus 32.2 +/- 12.9 cm/s, p < 0.05). Parenchymal vascularity of the thyroid gland was higher in hyperthyroid patients than in euthyroid patients irrespective of therapy. In both groups on therapy, the dose of carbimazole correlated with the vascularity of the gland (r = 0.492 versus 0.564, p < 0.05). Colour Flow Doppler Sonography parameters correlated significantly with pertechnate scan results giving comparable sensitivity and specificity. CONCLUSION: Assessment of thyroid blood flow by CFDS is an effective marker in the initial diagnosis of Graves' disease. Vascularity of the gland can predict long term disease course while on medical therapy.

Evaluation of thyrotoxicosis during pregnancy with color flow Doppler sonography.

OBJECTIVE: To determine whether color flow Doppler sonography (CFDS) is useful in differentiating Graves vs non-Graves thyrotoxicosis during pregnancy, when nuclear imaging is contraindicated. METHODS: Ten pregnant women with thyrotoxicosis were divided into Graves, and non-Graves, disease groups and were evaluated by CFDS for thyroid volume, vascularity, and inferior thyroid artery (ITA) flow velocity. Each patient was matched with a euthyroid woman of the same pregnancy duration. RESULTS: Of the 10 patients, 3 were diagnosed with Graves disease, 4 with gestational toxicosis, and 3 with destructive thyroiditis. Those in the Graves disease group had a greater thyroid gland volume (18.9+/-1.5 cm3 vs 12.1+/-2.4 cm3; P<0.05), greater thyroid vascularity, and greater ITA flow velocity than those in the non-Graves disease group (92+/-13 cm/s vs 20.4+/-2.4 cm/s; P<0.05). There was no significant difference in the corresponding values between the patients with gestational toxicosis and those with destructive thyroiditis or between them and their healthy controls. CONCLUSION: Thyroid evaluation by CFDS is useful for the differential diagnosis of thyrotoxicosis in pregnant women.

Efficacy of teriparatide in increasing bone mineral density in postmenopausal women with osteoporosis--an Indian experience.

BACKGROUND AND OBJECTIVE: Osteoporosis is emerging as a leading cause of substantial morbidity in India, particularly in postmenopausal women. Teriparatide (recombinant human parathyroid hormone [1-34]) increases bone formation and improves bone microarchitecture, thereby reducing the risk of fractures. This study was conducted to evaluate the efficacy of teriparatide in increasing bone mineral density (BMD) in postmenopausal women with osteoporosis. MATERIAL AND METHODS: A randomised, prospective, multicentre, open-label, controlled study was conducted on 82 postmenopausal women with established osteoporosis. Patients were randomly divided into control and teriparatide groups, each group consisting of 41 patients. All the patients were supplemented with 1000 mg of elemental calcium and 500 IU of vitamin D throughout the study period of 180 days. Besides, teriparatide group patients were administered teriparatide 20 microg daily subcutaneously. Lumbar spine, femoral neck and total hip BMD, bone mineral content (BMC) and bone area were measured by dual energy x-ray absorptiometry (DXA) at baseline and at the end of 6 months of treatment. Bone biomarkers, such as serum bone specific alkaline phosphatase (BSAP) and serum osteocalcin (OC), representing bone formation, and urinary deoxypyridinoline (DPD), representing bone resorption were assessed at baseline, and at 3 and 6 months of treatment. RESULTS: During the study period, 9 patients (11%) were lost to follow-up--6 in control group (7.3%) and 3 in teriparatide group (3.7%). There was an excellent compliance to both oral and injectable medication. The investigational product teriparatide was well tolerated and there were no serious adverse events. In addition, there were no significant differences between the groups in the incidence of adverse events. The percentage of increase in lumbar spine BMD, which is the primary endpoint, was significantly (P < 0.001) higher in teriparatide group compared to that in control group (6.58% vs. 1.06%). Further, teriparatide significantly increased percentage of change in lumbar spine T-score (P < 0.001), BMC (P < 0.001) and bone area (P < 0.028) compared to control group at 6 months. Administration of teriparatide resulted in a significant percentage of increase in all the bone biomarkers in teriparatide group compared to control group patients at 3 and 6 months over baseline, thereby showing that there was a significant increase in bone turnover in teriparatide group of patients. CONCLUSION: These results show that teriparatide is an effective and safe drug in increasing the BMD and therefore, teriparatide provides yet another new therapeutic option for reducing the risk management of osteoporosis in postmenopausal women (clinicaltrials.gov number, NCT00500409).

Symptomatic primary hyperparathyroidism: a retrospective analysis of fifty one cases from a single centre.

OBJECTIVE: Widely prevalent vitamin D deficiency and delayed diagnosis contributes to severe symptomatic primary hyperparathyroidism in India. We analysed fifty one consecutive patients of primary hyperparathyroidism managed at our centre. All of them were symptomatic. DESIGN: Retrospective analysis. MATERIAL AND METHODS: Fifty one consecutive cases of symptomatic primary hyperparathyroidism, presenting to our centre from January 1994 to May 2007 were retrospectively analyzed. Clinical presentation, biochemical, radiological and details of underlying parathyroid lesion were noted. RESULTS: A total of 51 cases of primary hyperparathyroidism were studied. Mean age was 39.5 +/- 11.5 yrs (Range 13 to 70 years, Female: Male 2:1). Mean duration of symptoms was 35.8 + 29.1 months. Bone pains and painful proximal myopathy were the commonest presentation (24/51), followed by pathological fractures in 12 cases. Distal Renal tubular acidosis was diagnosed in 4 cases, 3 of whom normalized after surgery. At initial evaluation, twenty one patients had elevated alkaline phosphatase with normal calcium levels indirectly suggesting associated vitamin D deficiency. Low serum levels of 25-hydroxy vitamin D were documented in five of them. Parathyroid carcinoma was diagnosed in 3 patients. Ectopic parathyroid adenoma was seen in 7 cases (3 mediastinal, 3 intrathyroidal, 1 near left carotid sheath). All the cases responded well to surgical excision. CONCLUSION: Lack of universal screening for hypercalcemia, normocalcemia contributed by associated vitamin D deficiency and lack of awareness about unusual presentations of primary hyperparathyroidism led to delayed diagnosis in our patients. Delayed diagnosis and associated vitamin D deficiency in our patients contributed to greater severity of symptomatic primary hyperparathyroidism.

Ectopic parathyroid adenoma--the hidden culprit.

Primary Hyperparathyroidism is known to present with protean manifestations leading to misdiagnosis in the initial stages of the disease. Inability to locate the adenoma in an ectopic parathyroid gland may further delay the diagnosis of these cases. Aberrant migration during development may lead to intrathyroidal or other ectopic locations of parathyroid glands. This may lead to their misdiagnosis as a thyroid nodule or failure to locate parathyroids during surgery. Similarity in cytological picture between thyroids and parathyroids may further complicate diagnosis by fine needle aspiration cytology. Nuclear imaging scintigraphy accurately localizes the tumor in 90% of cases and simplifies the surgical management. We encountered three such cases with the parathyroid gland adenomas in ectopic locations in which pre-operative nuclear imaging played a major role.

Discordance between lipid markers used for predicting cardiovascular risk in patients with type 2 diabetes.

AIMS: Non-high density lipoprotein cholesterol (non-HDL-C) is gaining importance over low density lipoprotein cholesterol (LDL-C) as cardiovascular risk marker in patients with type 2 diabetes. It represents the overall lipid burden and is a surrogate marker for the apolipoprotein B. We studied the discordance between the old (LDL-C) and the new (non-HDL-C) lipid markers in a large group of diabetes patients. METHODS: The lipid profile data of all diabetes (T2DM, aged 18-75, using oral or injectable anti diabetic agents) patients was analyzed in this study. We excluded patients with type1 diabetes, secondary forms of diabetes and gestational diabetes. Elevated lipid parameters (LDL>100mg/dL and non HDL-C>130mg/dL) were defined as per the guidelines of Adult Treatment Panel III. RESULTS: The study participants (409 M:360 F) had a mean age of 47.3±12.4 years, BMI of 28.4±5.6kg/m(2) and an A1c of 8.8±2.2%. Elevated LDL-C was observed in 383 patients (49.8%) and elevated non HDL-C in 418 (54.4%) patients. Of the 383 patients with elevated LDL-C, 346 (90.3%) had corresponding elevated levels of non-HDL-C and out of 418 patients with elevated non HDL-C, 346 (83%) had elevated LDL-C. Discordance between the elevated LDL-C and non-HDL-C values were greater among patients with low triglyceride levels when compared with those with high triglycerides (Pearson's χ(2) test=67.7; P<0.001). CONCLUSION: Our data suggest a significant discordance between the LDL-C and non-HDL-C in patients with diabetes. This discordance leads to the residual cardiovascular risk in diabetes patients.

Teneligliptin real-world efficacy assessment of type 2 diabetes mellitus patients in India (TREAT-INDIA study).

BACKGROUND AND AIMS: Teneligliptin was introduced in India in May 2015. It has gained popularity and is already widely prescribed in type 2 diabetes mellitus (T2DM). This "real life" data collection was conducted to assess the efficacy of teneligliptin in Indian T2DM patients. METHODS: Predesigned structured proforma was used to collect information from the prescribing physicians regarding the efficacy of teneligliptin when prescribed as monotherapy as well as combination therapy with other antidiabetic drugs in T2DM patients. Information on the glycemic parameters at baseline prior to starting teneligliptin and at the end of 3 months therapy was collected. The efficacy was assessed by analyzing the mean change in 3-month values of glycosylated hemoglobin (HbA1c), fasting plasma glucose (FPG), and postprandial plasma glucose (PPG). RESULTS: Data of 4305 patients was available for analysis. There was statistically significant improvement in mean HbA1c, FPG, and PPG with teneligliptin therapy. Means changes in HbA1c, FPG, and PPG were -1.37%±1.15%, 51.29±35.41 mg/dL, and 80.89±54.27 mg/dL, respectively. Subgroup analysis revealed that HbA1c (%) reduction with teneligliptin when used as monotherapy, add-on to metformin or add-on to metformin plus sulfonylureas combination, add-on to metformin plus alpha glucosidase inhibitor combination or add-on to insulin was 0.98±0.53, 1.07±0.83, 1.46±1.33, 1.43±0.80, and 1.55±1.05, respectively. CONCLUSION: Real-world data suggests that teneligliptin significantly improves glycemic control in Indian patients with T2DM when prescribed either as monotherapy or as an add-on to one or more other commonly prescribed antidiabetic drugs.

Prevalence of vitamin D deficiency across the spectrum of glucose intolerance.

BACKGROUND: Vitamin D deficiency (VDD) is inversely associated with insulin resistance. We studied the prevalence of VDD across the spectrum of glucose intolerance, including normal glucose tolerance (NGT), prediabetes (PD) and type 2 diabetes (T2D). METHODS: We conducted this cross-sectional, observational study by serially including the PD and T2D patients seen between June and December 2014. We excluded patients with major illness, secondary diabetes and use of vitamin D or glucocorticoids. VDD was defined as serum 25-hydroxy vitamin D (25OHD) less than 30 ng/mL. The study population was divided into 3 groups: T2D (Group 1; n = 274), PD (Group 2; n = 62) and NGT controls (Group 3; n = 270) for the analysis and appropriate statistical methods were used. RESULTS: The study participants (n = 606, 28 % males) had a mean age of 43.2 ± 13.6 years, BMI of 27.7 ± 5.9 kg/m(2), HbA1c of 6.6 ± 2 % and mean 25OHD of 18.8 ± 15.7 ng/mL. VDD was seen in 85 % of the entire study population including 84 % in T2D, 77 % in prediabetes and in 87 % of the controls. The mean 25OHD levels were lower in the control group (16.8 ng/mL) when compared with T2D and prediabetes (19.9 and 22.4 ng/mL) respectively (P = 0.0124). Univariate analysis showed higher odds of VDD in females (P < 0.0001) but no association with diabetes, age, BMI and HbA1c. CONCLUSION: Our data showed that VDD is prevalent in the majority of the population, irrespective of the underlying glucose intolerance. Further studies are required to determine the association between the vitamin D and diabetes.

Pulse oximetry for the assessment of autonomic neuropathy in diabetic patients.

Altered vascular responses to various thermal stimuli correlate well with the changes of autonomic neuropathy. These responses were assessed by the use of pulse oximetry. Standard cardiac autonomic function tests were performed in normal subjects (n = 12), diabetic patients without autonomic neuropathy (n = 8), and diabetic patients with autonomic neuropathy (n = 7). Autonomic functions in the same patients then were assessed by estimating the severity of vasospasm in response to cold stimulus with the help of pulse oximetry. Percentage fall in oxygen saturation at 15, 30, 60, 90, and 120 sec of exposure to cold stimulus was recorded on pulse oximeter. Time required for recovery and presence or absence of rebound rise following removal of cold stimulus were noted. In diabetics with autonomic neuropathy, the rate of fall in percentage oxygen saturation was significantly slower (p < 0.0001), less intense (p < 0.0001) and with delayed subsequent recovery (p = 0.013), compared to normal subjects. Rebound rise in oxygen saturation was absent in all the diabetics with autonomic neuropathy, compared to 2 of 12 normal subjects (p < 0.0001). We conclude that pulse oximetry may be a potentially useful, simple, and noninvasive bedside method for assessment of diabetic autonomic neuropathy.

Growth hormone-producing pituitary tumours: clinical profile and results of surgery.

BACKGROUND: Growth hormone-producing pituitary tumours present with a wide variety of manifestations. The optimum diagnostic work up, management and follow up of such patients is complex and involves a multidisciplinary approach. There is paucity of data from India with regard to the clinical presentation and results of surgery for growth hormone-producing tumours. METHODS: We studied the first 50 patients presenting during 1989-94 with growth hormone-producing pituitary tumours to our centre. The work up included detailed endocrine and radiological assessment. The surgical outcome was analysed for 35 patients who were operated (trans-sphenoidal 29, transcranial 6) at our centre. RESULTS: All the patients had macroadenomas [mean (SD) diameter 3.12 (0.87) cm]. Seventy-five per cent of the patients had supra- and/or parasellar extension and 57% had visual field defects. Tumour size correlated with the preoperative basal (r = 0.57) and glucose-suppressed (r = 0.54) growth hormone levels. Thirty-three of the 35 patients operated at our centre (trans-sphenoidal 28, transcranial 5) were available for follow up (median duration 34 months). After trans-sphenoidal surgery alone, 12 of the 28 (43%) patients had normalization of growth hormone levels (post-glucose growth hormone < 5 ng/ml), and 9 of 11 (82%) showed improvement in visual fields. CONCLUSION: In India, growth hormone-producing pituitary tumours are usually large in size. The growth hormone levels correlate with the size of the tumour. These tumours can be effectively treated by trans-sphenoidal or transcranial surgery.