Research Projects Internationally Funded "Effects of a Selective estrogen modulator on Vertebral Fracture Incidence and on Invasive Breast Cancer Incidence in Postmenopausal Women with Osteoporosis or with Low Bone Density" 2004-2007( Phase III) - Principal Investigator - Dr M S Seshadri. The study drug is a selective estrogen receptor modulator athat demonstrates estrogen agonist effect onbone and lipid metabolism and estrogen antagonist effect on breast and uterine tissue. The study is conducted on 71 patients at our site.The primary objective is to establish that treatment with the study drug decreases the risk of vertebral fractures compared with placebo, and decreases the incidence of invasive breast cancer compared with placebo. Postmenopausal evaluation and risk reduction with Lasofoxifene 2001-2007 . Principal Investigator - Dr MS Seshadri. Glucose Reduction and its Impact on Atherosclerosis on the Carotid Endothelium.: 2003-2008. [PHASE III] - Dr Nihal Thomas. ORIGIN (Outcome Reduction with Initial Glargine Reduction): This is an ongoing multicentric randomised, 2x2 factorial study.The two factors are insulin glargine (Variable dose vs. Standard care), and omega-3 fatty acid (865mg vs. placebo). Principal Investigator- Dr Nihal Thomas The study is evaluating the risk of reducing cardiovascular morbidity and mortality in high risk people with Impaired Fasting Glucose (IFG), Impaired Glucose Tolerance (IGT) and Early Type -2 Diabetes Mellitus. Our centre is the highest recruiters in Asia. The study was published in American Heart Journal January 2008; this is a 5 year study, started in Sep 2004. Bone Densitometry in patients with insulin analogues- a prospective study. (International Co-Author and Co-PI). Papaioannou A, Thomas N, Kanakamani. A Multinational trial jointly conducted by Mcmaster University, Hamilton and Christian Medical College, Vellore. 2005-2007.Principal Investigator - Dr Nihal Thomas. Inhaled Insulin study in patients with obstructive lung disease. Multinational trial. 2006-2007. [PHASE III].- Principal Investigator- Dr Nihal Thomas. Oral Insulin Study. Multinational trial 2006-2007. [PHASEII]. 2006-2007. Study completed - PrincipalInvestigator- Dr Nihal Thomas. Saxagliptin Study Multinational trial 2006-2007(Site PI) [PHASE III] - Principal Investigator- Dr Nihal Thomas ACCORD Study. Avosentan Study (Endothelin n Antagonist) in treatment of diabetic nephropathy.(Site PI) [PHASE III]. 2006-2007.(Study Terminated )Principal Investigator- Dr Nihal Thomas Study on DPPV-4 antagonists in patients on Oral Hypoglycaemic agents. [PHASE III]. 2006-2008 - Principal Investigator- Dr Nihal Thomas Inhaled Insulin Study in patients with Type 2 Diabetes Mellitus. [PHASE III]. 2006-2007 - Principal Investigator- Dr Nihal Thomas PPAR gamma agonist as an add on therapy for patients with Type 2 diabetes Mellitus. [PHASE II/III]. 2006-2008 -Principal Investigator- Dr Nihal Thomas. The study drug is a new class of highly potent PPAR gamma agonist, which does not cause edema or weight gain also not affect fluid retention. Metabolex study is a Phase 2/3, Randomized, Double-blind, Placebo-and Active Comparator-controlled, Parallel group, Multicenter, 24 weeks Study to determine the Safety and Efficacy of Metaglidasen in the Treatment of Type 2 Diabetes In Patients Sub-optimally Controlled on Insulin. Totally 20 patients enrolled in the study. Currently 10 patients successfully completed the study. Study : A Phase 2B long term Randomised Open label safety and tolerability trial comparing a Selective Serotonin Reuptake inhibitor with routine care in patients with chronic painful diabetic peripheral Neuropathy (2007-2010 )- Principal Investigator- Dr Nihal Thomas Chronic Painful diabetic neuropathy affects up to one quarter of patients with diabetes mellitus and results in a significant impairment of thier quality of life . The study is phase 2 for a period of 2 years in subjects with painful diabetic peripheral neuropathy . The study drug is a selective serotonin reuptake inihibitor, which enhances the noradrenergic neurotransmission in the spinal cord and produces analgesic effect. The objective of this study is to assess the long term safety ,tolerability and efficacy of the study drug, including the effect on health related quality of life in subjects with diabetic peripheral neuropathy. The subjects are assessed for thier neuropathic pain and general healthcare as part of thier routine diabetic care. Our centre is the highest recruiter globally. Study for inhaled insulin in Type 2 diabetes with normal pulmonary function. 2007-2009 -Principal Investigator- Dr Nihal Thomas. Indian Polypill study 2007-2008. Principal Investigator- Dr Nihal Thomas A randomised double-blind controlled trial of the efficacy and safety of POLYCAP versus its components in subjects with at least one additional cardio-vascular risk factor. Cardiovascular disease is the leading cause of death in the world. The polycap is a fixed 5 drug combination of an antiplatelet drug , an antihypertensive drug , Angiotensin converting enzyme inhibitor , thiazide diuretic and a lipid lowering agent. Studies have shown that a combination of the above drugs can result in a cumulative risk reduction of cardiovascular disease events. Our centre has 39 ongoing subjects between the age group of 45 to 80 years with atleast one additional cardiovascular risk factor. The polycap is evaluated for reduction in heart rate , blood pressure , platelet aggregation , lipid modification and platelet aggregation .The study also evaluates the rates of adverse events. The total duration of the study is for four months .The study is developed by St Johns Medical college , Bangalore and Mc Master University , Canada. Christian Medical College is also part of the Steering committee of the Indian Polycap Study. Multicentre study to compare the effect of study drug (DPP-1V) inhibitor with Gliclazide as add on therapy with Metformin. Principal Investigator- Dr Nihal Thomas DPP IV inhibitor is a novel class of antihyperglycemic drug . DPP-IV inhibitors can increase circulating levels of endogenous GLP-1(Glucagon Like Polypeptide-1) and GIP (Gastric Inhibitory Polypeptide) thereby improves glucose homeostasis in Type 2 Diabetes Mellitus subjects.I.The study is testing the hypothesis that the HbA1c reduction with study drug is not inferior to gliclazide. This study is done in an elderly population of age above 65 yrs. This is a 52 weeks study started in May 2007. Soluble Insulin Basal Analogue in the management of Type 2 diabetes three types of doses versus glargine. [PHASE II]. 2008-2009.Principal Investigator- Dr Nihal Thomas The study drug is a long acting insulin analogue which can be used as a once daily injection at night . The safety and efficacy of the drug is studied. The pharmacokinetic and pharmacodynamic and insulin antibody evaluation is also conducted. It is a 16 week study and our site has recruited 52 patients .Primary objective is to assess glucose control with respect to Hba1c after 16 weeks of treatment with study drug given once daily and study drug given on Monday , wednesday and friday and insulin glargine given once daily , all in combination with Metformin in subjects with Type 2 Diabetes .The study also compares the efficacy and safety in terms of body weight , 9 Point plasma glucose profile , lipid profile, frequency of hypoglycemic events . The site is the largest recruiter globally. ALTITUDE( Trial in Type 2 diabetes Using CardioRenal Disease Endpoints)- Principal Investigator- Dr Nihal Thomas: The study drug is a new class of antihypertensivedrug - a renin inhibitor. It was approved by the U.S. Food and Drug Administration in 2007 for the treatment of hypertension. .This Multicenter event driven study is an ongoing study in our department. The aimof the study is to determine whether the study drug can reduces cardiovascular and renal morbidity and mortality in subjects Type 2 Diabetes, who are at high risk for cardiovascular and renal events. At present 14 had volunteered for our study, of which 2 were randomized. It’s an event driven study initiated in March 2008. Projects Nationally Funded Prospective Study in the Usage of Metformin versus Glibenclemide in Patients with gestational diabetes mellitus - Dr Jiji Mathew, Dr MS Seshdri, Dr Nihal Thomas. Prospective study of the metabolic parameters- glycaemic and bone densitometry of patients with chronic pancreatitis and diabetes mellitus- (2005-2008) - Dr Sudeep, Dr Nihal Thomas, Dr Kishore. Prospective study of Erectile dysfunction in patients with diabetes mellitus- ongoing 2006 - Dr Senthil Vasan, Dr Sivan Arul Selvan, Dr Nihal Thomas. Prospective study of Cystopathy in patients with Type 2 Diabetes mellitus- ongoing 2006. - Dr Shamugasundaram, Dr Nitin Kekre, Dr Nihal Thomas. Department Initiated Research Copenhagen University Collaboration on: Low Birth Weight and the risk of glycaemic disorders as assessed by glucose-insulin clamp studies, indirect calorimetry and Hydrogen Nuclear magnetic spectroscopy. 2006-2009. (PI)- Dr Nihal Thomas. Study of Immunogenetic Pattern in Type 1 diabetes in South India - Dr Nihal Thomas , Dr Senthil Vasan. Bone mineral density and vitamin D status in subjects who are on long term anticonvulsant medication. Thomas V Paul P, TGK Bone mineral density and vitamin D status in postmenopausal subjects who are admitted with Hip fracture. Dr Thomas V Paul. Bone mineral density and vitamin D status in patients infected with HIV infection who were on HAART therapy. Dr M S Sheshadri , Dr Thomas Paul , Asha H S, study of Immunogenetics of gestational Diabetes and New borns and Offsprings born to Diabetic Mothers - Dr Nihal Thomas , Dr Senthil.Vasan Study on Prevelance of Metabolic syndrome in young asian Indian . Dr Nihal Thomas , Dr Senthil Vasan Vitamin D Status and Calcium Metabolism in Ambulatory patients on Antiepileptic Drugs. Dr George koshy The burden of Osteoporosis in healthy males more than 40 years of age and the Influence of life style factors, Calcium intake and Vitamin D status on Bone Mineral Density from a suburban region in South India. Dr Suresh Prabhu Assessing Energy Expenditure in patients with Fibro Calcific Pancreatic Diabetes to help in determining dietary Calorie requirement. Dr Dr Kishore Kumar Behera. Prevalence of vitamin D deficiency and other risk factors in patients with acute Hip fracture.Dr Sivan Arul Selvan. Establishing the significance and correlation of Homa, Quicki, Fgir, Matsuda and McAuley's Indices with hyperinsulinemic euglycemic clamp in young South Indian males.Dr Rachaprolu Spurgeon Body Composition and Metabolic Abnormalities in HIV infected Men. Dr Asha HS