Metformin in Overweight Type 2 Diabetes Mellitus

• Status: Completed
• Trial end date: 2008-12-01
• Target enrollment: 0
• Participant gender: All

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 reinforced at each follow-up visit. In addition they were prescribed extended release metformin (XR) in a gradually increasing tolerable dose, starting with 0.5g twice a day after meals. In addition, hypertension and dyslipidemia, when present, were treated with appropriate recommended drugs. Those who completed a satisfactory regular follow-up for at least 12 months or more were then analyzed for changes in their anthropometric measurements and glycemic control.

• Phase: N/A
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Era's Lucknow Medical College
• Treatments: Metformin

Criteria

Inclusion Criteria:

• Type 2 Diabetes Mellitus

• BMI more than 25

Exclusion Criteria:

• 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