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A comparison of various antioxidant preparations on insulin sensitivity in Type 2 diabetes patients

Phase 4
Completed
Registration Number
CTRI/2009/091/000200
Lead Sponsor
MERCK India Ltd
Brief Summary

Not available

Detailed Description

Not available

Recruitment & Eligibility

Status
Completed
Sex
Not specified
Target Recruitment
0
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

Study & Design

Study Type
Interventional
Study Design
Not specified
Primary Outcome Measures
NameTimeMethod
Secondary Outcome Measures
NameTimeMethod
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