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Clinical Trials/CTRI/2009/091/000200
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

Sponsor
MERCK India Ltd

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