A ProspectIve, OpeN-Label, Randomized Study Comparing EffIcacy and Safety of Teneligliptin VErsus Sitagliptin in Indian Patients with Inadequately Controlled Type 2 Diabetes Mellitus: INSITES Study.

BACKGROUND: Teneligliptin is widely prescribed dipeptidyl peptidase-4 inhibitor (DPP-4i) in India because of its economical pricing. However, there is no headto-head trial comparing teneligliptin with any other DPP-4i in Indian setting. We evaluated the efficacy and safety of teneligliptin versus sitagliptin as add-on to metformin and/or sulfonylureas in patients with type 2 diabetes mellitus (T2DM). METHODS: This prospective, open-label, randomized, active-controlled study enrolled 76 patients (1:1) at 2 centres. Patients received teneligliptin 20 mg or sitagliptin 100 mg orally once daily for 12 weeks as add-on to ongoing metformin or sulfonylurea therapy. Primary endpoint was mean change in glycosylated hemoglobin (HbA1c) from baseline at week 12. RESULTS: Both arms were comparable (p>0.05) at baseline in terms of age, gender, metformin daily dose, sulfonylurea use, HbA1c, fasting and postprandial blood glucose (FBG and PPBG). At the end of 12 weeks, statistically significant reductions were observed in both teneligliptin and sitagliptin arms in HbA1c (-1.19 ± 1.16% p<0.0001 and -0.92 ± 0.95%, p<0.0001), in FBG (-28.3 ± 63.0 mg/dL, p= 0.01 and -22.9 ± 47.4 mg/dL, p=0.006) and PPBG (-41.3 ± 85.4 mg/dL, p=0.006 and -54.7 ± 85.6 mg/dL, p=0.0005). The reductions in all glycemic parameters were similar between the arms. Both gliptins were well-tolerated with no difference in the number of adverse events. There was no change in QT/QTc intervals or other ECG parameters at week 12 in both arms. In post-hoc comparison, percentage of patients achieving target HbA1c <7% (as per American Diabetes Association guidelines) at week 12 favored teneligliptin arm over sitagliptin arm (33.3% vs. 19.4% patients). CONCLUSION: Teneligliptin provided similar glycemic control as compared to sitagliptin and reduced HbA1c, FBG and PPBG values significantly within 12 weeks of treatment. Both gliptins were found to be safe and well-tolerated in Indian patients with T2DM.

Prevalence of depression among the elderly (60 years and above) population in India, 1997-2016: a systematic review and meta-analysis.

BACKGROUND: There is lack of information on the magnitude of depression among elderly population in India. This systematic review and meta-analysis aimed to estimate the prevalence of depression among elderly population in India. METHODS: PubMed, Scopus, Web of Science, Embase, PsycINFO, IndMed, and Google Scholar were searched to identify articles reported community-based prevalence of depression among elderly population using screening tools. This study included the articles published during the years 1997 to 2016. Studies conducted in the special population groups, hospitals, reported only a subcategory of depression, and not specified the screening tool were excluded. Data were extracted from published reports and any missing information was requested from authors. Estimates were pooled using random-effects meta-analyses. Subgroup and sensitivity analysis were performed. The publication bias was evaluated by using Egger's test and visual inspection of the symmetry in funnel plots. RESULTS: Fifty-one studies from 16 States of India were included as 56 datasets, which estimated the prevalence of depression among Indian elderly population as 34.4% (95% CI: 29.3-39.7). In sub-group analysis, the pooled prevalence was higher among females, rural populations, and in the eastern part of the country. Studies using non-probability sampling, and GDS and CES-D screening tool showed higher prevalence. Exclusion of the studies with sample size less than 100 and low-quality studies (score < 5/8) had no effect on the estimate of the prevalence. The studies that excluded dementia before assessment of depression had lower prevalence. CONCLUSION: About one third elderly population of India suffered from depression with female preponderance. The estimates varied with type of study tool, geographic region, sampling methods, and presence of dementia. The pooled estimate should be interpreted with caution as the studies included in this review had varied methodological approach and screening tools.

Ultrasonic-assisted synthesis of ZnTe nanostructures and their structural, electrochemical and photoelectrical properties.

Colloidal zinc telluride (ZnTe) nanostructures were successfully processed through a simple and facile ultrasonic (sonochemical) treatment for photoelectronic applications. The particle-like morphological features, phase and nature of valence state of various metal ions existing in ZnTe were examined using electron and X-ray photoelectron spectroscopic tools. Raman spectroscopic measurements revealed the dominance of exciton-phonon coupling and occurrence of TeO2 traces in ZnTe through the corresponding vibrations. Optical bandgap of the ZnTe suspension was estimated to be around 2.15eV, authenticating the direct allowed transitions. The p-type electrical conductivity and charge carrier density of ZnTe were additionally estimated from the Bode, Nyquist and Mott-Schottky type impedance plots. The photoelectrical properties of ZnTe were investigated by fabricating p-ZnTe/n-Si heterostructures and studying their corresponding current-voltage characteristics under dark and white light illumination. The diodes revealed excellent rectifying behaviour with significant increase in reverse current under illumination. The stability of the devices were also affirmed through the time-dependent photoresponse characteristics, which actually suggested the improved and effective separation of photo generated electron hole pairs across the integrated heterojunctions. The obtained results also augment the potential of sonochemically processed ZnTe for application in photo detection and sensor related functions.

The INtegrating DEPrEssioN and Diabetes treatmENT (INDEPENDENT) study: Design and methods to address mental healthcare gaps in India.

INTRODUCTION: Depression and diabetes are highly prevalent worldwide and often co-exist, worsening outcomes for each condition. Barriers to diagnosis and treatment are exacerbated in low and middle-income countries with limited health infrastructure and access to mental health treatment. The INtegrating DEPrEssioN and Diabetes treatmENT (INDEPENDENT) study tests the sustained effectiveness and cost-effectiveness of a multi-component care model for individuals with poorly-controlled diabetes and depression in diabetes clinics in India. MATERIALS AND METHODS: Adults with diabetes, depressive symptoms (Patient Health Questionnaire-9 score≥10), and ≥1 poorly-controlled cardiometabolic indicator (either HbA1c≥8.0%, SBP≥140mmHg, and/or LDL≥130mg/dl) were enrolled and randomized to the intervention or usual care. The intervention combined collaborative care, decision-support, and population health management. The primary outcome is the between-arm difference in the proportion of participants achieving combined depression response (≥50% reduction in Symptom Checklist score from baseline) AND one or more of: ≥0.5% reduction in HbA1c, ≥5mmHg reduction in SBP, or ≥10mg/dl reduction in LDL-c at 24months (12-month intervention; 12-month observational follow-up). Other outcomes include control of individual parameters, patient-centered measures (i.e. treatment satisfaction), and cost-effectiveness. RESULTS: The study trained seven care coordinators. Participant recruitment is complete - 940 adults were screened, with 483 eligible, and 404 randomized (196 to intervention; 208 to usual care). Randomization was balanced across clinic sites. CONCLUSIONS: The INDEPENDENT model aims to increase access to mental health care and improve depression and cardiometabolic disease outcomes among complex patients with diabetes by leveraging the care provided in diabetes clinics in India (clinicaltrials.gov number: NCT02022111).

Determination of environmental radioactivity (238U, 232Th and 40K) and indoor natural background radiation level in Chennai city (Tamilnadu State), India.

An extensive study on the determination of the natural radioactivity ((238)U, (232)Th and (40)K) levels in soil samples of Chennai city, India has been undertaken and the results of the same are compared with the levels reported in other Indian cities as well as other parts of the world. The radioactivity content in the soil samples, the absorbed dose rate, annual effective dose equivalent, radium equivalent activity, internal and external hazard indices were calculated and compared with UNSCEAR 2000 recommended values. In addition to the above, mapping of indoor natural background gamma radiation levels has been made using thermo luminescent dosemeters throughout Chennai city and the same are reported.

Accumulation of few heavy metals in sewage sludges, soils and plants of Coimbatore, Tamil Nadu (India).

A study was carried out in Coimbatore district of Tamil Nadu (India) to assess the distribution pattern of heavy metals in the soils and plants irrigated with sewage effluent/sludge. About 69 soil samples (surface and subsurface), 65 plant samples as well as 34-sewage sludge samples were collected from various tehsils of Coimbatore. Six tehsils in Coimbatore have been identified and categorized into two groups--Class I City (densely populated tehsils) and Class II city (thinly populated tehsils). The available micronutrients like Fe, Mn, Zn and Cu; heavy metals: Cr, Cd, Ni, and Pb were within the safe limits. However, the total Cr and Cd concentrations were relatively higher in the sludge samples collected from Coimbatore and Tiruppur tehsils compared to other tehsils, while for Ni, the sequence was in the order Coimbatore > Tiruppur > Palladam > Pollachi > Avinashi > Mettupalayam and for Pb, Coimbatore > Mettupalayam > Palladam > Tiruppur > Avinashi > Pollachi. Soil analysis results indicated that heavy metal concentration recorded higher level in soils of Class I city (densely populated tehsils) compared to Class II city (thinly populated tehsils). The plant samples analyzed had also registered higher concentration of total Cd, Ni and Pb, which were classified under toxic, excessive and below excessive level, respectively. Correlation analysis revealed that iron (Fe), zinc (Zn), copper (Cu), cadmium (Cd) and lead (Pb) were significantly negatively correlated with pH of soil. EC had a significant positive correlation with available iron (Fe), zinc (Zn), cadmium (Cd) and lead (Pb). A significant positive correlation of Fe, Mn, Zn, Cu, Cd and Pb was also registered with OC. Among the plant samples collected, it was evident that heavy metal concentrations were recorded higher in grass spp followed by Amaranthus spp. It was inferred from the study that soils samples had higher levels of heavy metals even though the values recorded were below the critical value/toxic limit. However, long-term and indiscriminate application of untreated (raw) sewage sludge and/or letting of sewage effluent directly to agricultural field without prior treatment may result in accumulation of toxic metals in surface and subsurface soils and subsequent biotransfer (bioaccumlation) into the food chain, it may further lead to toxicity not only to plants and animals but also to consumers of the harvested crops.

Heavy metal contamination in bore water due to industrial pollution and polluted and non polluted sea water intrusion in Thoothukudi and Tirunelveli of South Tamil Nadu, India.

This study investigates the pollution vulnerability of bore water in the coastal region of Tirunelveli and Thoothukudi in the state of Tamilnadu, India. There are no industries in the Tirunelveli Coastal area whereas there are many industries in SIPCOT (State Industries Promotion Corporation of Tamilnadu) Thoothukudi, and coastal area of Thoothukudi. Bore water from the SIPCOT, coastal area of Thoothukudi and Tirunelveli were collected periodically from July 2006 to May 2008 for this study. These samples were tested and analyzed to find the concentrations of sodium, magnesium, aluminium, potassium, calcium, copper, cadmium, mercury and lead. The toxic cadmium concentration was found in the range of 0.00-0.22 mg Kg⁻¹ at SIPCOT 2 in November 2007, mercury 0.00-0.024 mg Kg⁻¹ and lead 0.00-0.02 mg Kg⁻¹ in SIPCOT 2 in January 2008. The level of contamination is higher than the WHO limits of drinking water standards; but copper and aluminium content are within the limit. On the other hand, the samples taken from bores in Tirunelveli coastal area are non-polluted, and the analysis shows that all the metals are within the limits of WHO standard.

Reliability and validity of a modified PHQ-9 item inventory (PHQ-12) as a screening instrument for assessing depression in Asian Indians (CURES-65).

OBJECTIVES: To evaluate the validity and reliability of the modified Patient Health Questionnaire(PHQ) 12 item instrument as a screening tool for assessing depression compared to the PHQ-9 in a representative south Indian urban population. METHODS: The Chennai Urban Rural Epidemiology Study [CURES] is a large cross-sectional study conducted in Chennai, South India. In Phase 1 of CURES(urban component), 26,001 individuals aged > or =20 years individuals were selected by a systematic sampling technique of whom one hundred subjects were randomly selected, using computer-generated numbers, for this validation study. Two self-reported questionnaires (modified PHQ-12 item and PHQ-9 item) were administered to the subjects to compare their effectiveness in detecting depression. Reliability and validity were assessed and Receiver Operating Characteristic (ROC) curves were plotted. Pearson's correlation was used to compare the two questionnaires. RESULTS: The mean age of the study was 38.6 +/- 11.6 years and 48% were males. Pearson's correlation coefficient between the modified PHQ-12 and the PHQ-9 item was 0.913 [p < 0.0001]. Factor Analysis revealed that the modified PHQ-12 item scale can be used as a unidimensional scale and had excellent internal consistency (Cronbach's alpha: 0.88). A cut point of >4 calculated using the ROC curves for the modified PHQ-12 item had the highest sensitivity (92.0%) and specificity (90.7%) using PHQ-9 as the gold standard. The positive predictive value was 76.7%, and the negative predictive value, 97.1% and the area under the ROC curve, 0.979 (95% Confidence Interval: 0.929 - 0.997, p < 0.0001). CONCLUSION: The modified PHQ-12 item is a valid and reliable instrument for large scale population based screening of depression in Asian Indians and a cut point score of greater than 4 gave the highest sensitivity and specificity.

Anti microbial activity of the various leaf extracts of Vitex negundo Linn.

The antibacterial activity of the leaves of Vitex negundo was tested against three types of bacteria Viz., Staphylococcus aureus, Escherichia coli and Klebsiella Pneumoniae. The fresh, aqueous, heated aqueous extract, chloroform and methanolic extract of leaves were used for screening their antibacterial potential. The fresh and aqueous extracts of leaves in various dilutions were found to have antibacterial activity against the three bacteria.

Evaluation of One Touch HORIZON--a highly affordable glucose monitor.

BACKGROUND AND OBJECTIVE: Despite the growing evidence on the benefits of self-monitoring in diabetes, the use of these meters has been low in developing countries, particularly India. Cost seems to be the major constraint. The aim of the present study is to evaluate the accuracy of One Touch HORIZON an affordable glucose meter with laboratory assessment of blood glucose. METHODS: 100 subjects with diabetes over the age of 18 years were recruited from the MV Diabetes Specialities Centre, Chennai. All the study subjects had their fasting blood tested for glucose in One Touch HORIZON by finger prick. Fasting blood glucose was also assessed in YSI 2300 STATPLUS (Yellow Springs Instruments, Ohio, USA) glucose analyzer. The Parke's Error Grid model was used to assess the accuracy of the meter against YSI plasma glucose values. RESULTS: Of the total 100 study subjects, 97 were Type 2 diabetic subjects and three were Type 1 diabetic subjects. 62% of the study subjects were males. 89% did not perform SMBG and only 2% of the diabetic subjects performed SMBG daily. The Parke's Error Grid analysis revealed 97% of results to be in Zone A when patient performed the test, 99 - 100% in Zone A when clinical staff performed the test indicating excellent accuracy and precision. CONCLUSION: One Touch HORIZON meter is an affordable meter with good accuracy and precision, specifically designed to cater to the needs of diabetic patients in developing countries.

Oral pancreatic enzyme therapy in the control of diabetes mellitus in tropical calculous pancreatitis.

CONCLUSION: Pancreatic enzyme supplementation therapy conducted during a 6 mo period produces better control of diabetes, improvement in nutrition, and overall improvement in quality of life in patients with tropical calculous pancreatitis. BACKGROUND: Tropical calculous pancreatitis is characterized by abdominal pain, pancreatic calculi, and diabetes. The diabetes in insulin resistant. The brittle diabetes may be owing to defective glucagon secretion and erratic absorption of nutrients. METHODS: Patients with tropical calculous pancreatitis with diabetes and chronic pancreatitis were studied for fasting and postprandial plasma glucose, glycosylated hemoglobin, serum cholesterol, triglycerides, and calcium, liver function, and plasma C-peptide. All patients were given Creon and evaluated for quality of life. RESULTS: Clinical parameters of the patients showed considerable improvement at the end of the trial. Abdominal pain, steatorrhea, and sense of well being improved. There was a significant reduction in postprandial plasma glucose and glycosylated hemoglobin.

Clinical profile of lean NIDDM in South India.

The majority (> 80%) of patients with non insulin dependent diabetes mellitus (NIDDM) present in Europe and America are obese. In developing countries like India, most NIDDM (> 60%) are non-obese and many are actually lean with a body mass index (BMI) of < 18.5 and are referred to as 'lean NIDDM'. This paper compares the clinical profile of a cohort of 347 lean NIDDM, with a group of 6274 NIDDM of ideal body weight (IBW) and 3252 obese NIDDM attending a diabetes centre at Madras in South India. The lean NIDDM who constituted 3.5% of all NIDDM patients seen at our centre, had more severe diabetes and an increased prevalence of retinopathy (both background and proliferative), nephropathy and neuropathy. Although a larger percentage of the lean NIDDM patients were treated with insulin, 47% of the males and 53% of the females were still on oral hypoglycaemic agents even after a mean duration of diabetes of 9.2 +/- 8.1 years. Studies of GAD antibodies, islet cell antibodies (ICA) and fasting and stimulated C-peptide estimations done in a small subgroup of the lean NIDDM showed that they were distinct from IDDM patients. More studies are needed on metabolic, hormonal and immunological profile of lean NIDDM seen in developing countries like India.