Status:

COMPLETED

Metformin in Overweight Type 2 Diabetes Mellitus

Lead Sponsor:

Era's Lucknow Medical College

Conditions:

Obesity

Type 2 Diabetes Mellitus

Eligibility:

All Genders

30-70 years

Phase:

NA

Brief Summary

The study included 102 overweight type 2 diabetes mellitus patients with a body mass index (BMI) of more than 25 in an open label study. They were advised intensive life style modification which was r...

Detailed Description

From 1st February 2006 till 31st December 2008, 800 cases of diabetes mellitus who attended the diabetes clinic constituted the subjects for the present study. Majority of the subjects were from the s...

Eligibility Criteria

Inclusion

  • Type 2 Diabetes Mellitus
  • BMI more than 25

Exclusion

  • Type 1 diabetes
  • pancreatic diabetes
  • presence of concomitant endocrinal disorder
  • non-overweight type 2 diabetes
  • type 2 diabetes with secondary failure to sulfonylurea and taking insulin
  • presence of proliferative retinopathy or chronic renal failure
  • known cirrhosis of liver
  • heavy alcoholic
  • presence of active tuberculosis
  • known HIV disease or any active infection
  • major mental illness
  • failure to comply with the exercise advice due to physical incapacity (e.g., severe osteoarthritis, hemiparesis or any other disabling neurological disease)
  • present pregnancy (or planning pregnancy)
  • lactating mothers
  • using any kind of hormones including oral contraceptives, systemic corticosteroids, nicotinic acid
  • use of anti-obesity drug within the past 3 months
  • chronic gastroparesis or chronic severe gastrointestinal symptoms
  • a history of gastric or duodenal ulcers
  • abdominal surgery within 1 year will not be included in the study
  • patients with congestive heart failure or overt nephropathy will also not be included, due to unreliability of anthropometric measurements in such subjects and the relative risk of lactic acidosis

Key Trial Info

Start Date :

February 1 2006

Trial Type :

INTERVENTIONAL

Allocation :

ACTUAL

End Date :

December 1 2008

Estimated Enrollment :

102 Patients enrolled

Trial Details

Trial ID

NCT00922194

Start Date

February 1 2006

End Date

December 1 2008

Last Update

March 23 2010

Active Locations (1)

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1

Sircar Diabetes Clinic

Lucknow, Uttar Pradesh, India, 226006