CTRI/2009/091/000200
Completed
Phase 4
A study of comparative effects of Antioxidants on Insulin Sensitivity in type 2 diabetes mellitus: A Randomized Double Blinded Placebo-Controlled Trial
MERCK India Ltd0 sites0 target enrollmentStarted: TBDLast updated:
Overview
- Phase
- Phase 4
- Status
- Completed
- Sponsor
- MERCK India Ltd
Overview
Brief Summary
No summary available.
Study Design
- Study Type
- Interventional
Eligibility Criteria
Inclusion Criteria
- •This study will enrol patients both men and women with age between 21\-60 years of known cases of type 2 diabetes mellitus, attending medicine or diabetic O.P.D of SGH Pune and having the following parameters \-indicative of decreased insulin sensitivity:\-
- •Any of the below two criteria:
- •1\)B.M.I \> 27 kg/m2 \- \< 40 kg/m2 17
- •2\)Waist circumference of \> 102 cm in men or \> 88 cm in women
- •3\)High\-density lipoprotein cholesterol (HDL\-C) level of \< 40 mg/dL in men or \< 50 mg/dL in women/ Fasting triglyceride level of 150 mg/dL or higher
Exclusion Criteria
- •1\)Patient with type 2 diabetes mellitus with blood glucose \> 250 mg/dL or patients who are currently on insulin therapy17
- •2\)Patients with uncontrolled hypertension ( Blood pressure \> 140/90mmHg in spite of anti HT drugs)
- •3\) Patients with complications of diabetes including nephropathy \& retinopathy17
- •4\)Patients with serum levels of triglycerides \>400 mg/dL17/ Patients with total cholesterol \> 400 mg/dL17
- •5\)Any history of MI/cardiac intervention or clinically active cardiovascular disease17
- •6\)Patients with known renal or hepatic diseases ( AST \> 82 U/L; ALT \> 76 U/L; Creatinine \> 1\.5mg/dL) 17 including any history of renal stones
- •7\)Pregnant females will be excluded
- •8\)Patients taking any long term medication except anti\-diabetic, antilipedimic and antihypertensive medicines.
- •9\)Unwillingness to give blood samples or mental incapacity to take the drugs
Investigators
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