The Effects of Calorie Restriction With or Without Metformin on Weight and Insulin Resistance

• Status: Completed
• Trial end date: 2004-05-01
• Target enrollment: 0
• Participant gender: All

Summary

This is a study to:

• Determine the difference between strong hypo-energetic "standard diet advice" and modest hypo-energetic "personal diet advice"; and

• Determine the influence of insulin-insensitivity on obesity and weight reduction by treating patients with metformin or placebo.

• Phase: Phase 4
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: University Hospital, Ghent
• Treatments: Insulin; Metformin

Criteria

Inclusion Criteria:

• 20-55 years of age

• Body mass index (BMI) equal to or greater than 30 kg/m²

• Insulin resistance as determined by oral glucose tolerance test (OGTT) and HOMA

Exclusion Criteria:

• Diabetes mellitus, kidney insufficiency, or hepatic insufficiency

• Hypogonadism with other etiology than overweight

• Pregnancy

• BMI equal to or greater than 40 kg/m²