Overview

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