The Effects of Calorie Restriction With or Without Metformin on Weight and Insulin Resistance
|ClinicalTrials.gov Identifier: NCT00134290|
Recruitment Status : Completed
First Posted : August 24, 2005
Last Update Posted : December 28, 2007
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.
|Condition or disease||Intervention/treatment||Phase|
|Body Weight Insulin Resistance||Drug: metformin Behavioral: "standard diet advice" Behavioral: "personal diet advice"||Phase 4|
The aim of the present study was to determine what the difference is of a strong hypo-energetic "standard diet advice" and a modest hypo-energetic "personal diet advice" which was determined by the energy needs of a person as calculated with a combination of basal metabolic rate (BMR) and physical activity level (PAL) on weight loss and insulin sensitivity.
Secondly, this study wanted to determine what the influence is of insulin-insensitivity on obesity and weight reduction by treating the patients with metformin or placebo. The subjects were therefore randomised into two double blinded groups receiving either metformin (2 x 850 mg per day) or placebo in combination with a moderate energy restriction and a exercise regimen of 30 minutes per day for 1 year.
Treatment effects of both diets and the effect of metformin on weight reduction and insulin sensitivity were determined after a treatment period of 20 and 52 weeks.
Insulin sensitivity was quantified using the homeostasis model assessment (HOMA) and the OGTT. Body composition was determined with the bioelectrical impedance method.
Blood was also drawn for hormonal and biochemical analyses after 20 and 52 weeks of treatment. Furthermore, the patients had to fill out a 3-day food diary at baseline, after 20 weeks and after 52 weeks.
|Study Type :||Interventional (Clinical Trial)|
|Enrollment :||48 participants|
|Intervention Model:||Parallel Assignment|
|Official Title:||The Effects of Calorie Restriction - Whether or Not Calculated Based on BMR (Basic Metabolic Rate) - With or Without Metformin on Weight and Insulin Resistance of Obese Insulin Resistant Patients|
|Study Start Date :||January 2002|
|Actual Study Completion Date :||May 2004|
- Effect of diet on weight and insulin sensitivity/insulin resistance after 20 and 52 weeks of treatment
- Effect of metformin on weight and insulin resistance after 20 and 52 weeks of treatment
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00134290
|University Hospital Ghent|
|Ghent, Belgium, 9000|
|Principal Investigator:||Mimi Giri, MD, PhD||University Hospital, Ghent|