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

This study has been completed.
Sponsor:
Information provided by:
University Hospital, Ghent
ClinicalTrials.gov Identifier:
NCT00134290
First received: August 23, 2005
Last updated: December 19, 2007
Last verified: December 2007

August 23, 2005
December 19, 2007
January 2002
Not Provided
Effect of diet on weight and insulin sensitivity/insulin resistance after 20 and 52 weeks of treatment
Effect of diet on weight and insulin sensitivity / insuline resistance after 20 and 52 weeks of treatment
Complete list of historical versions of study NCT00134290 on ClinicalTrials.gov Archive Site
Effect of metformin on weight and insulin resistance after 20 and 52 weeks of treatment
Same as current
Not Provided
Not Provided
 
The Effects of Calorie Restriction With or Without Metformin on Weight and Insulin Resistance
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

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.

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.

Interventional
Phase 4
Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double-Blind
Primary Purpose: Treatment
  • Body Weight
  • Insulin Resistance
  • Drug: metformin
  • Behavioral: "standard diet advice"
  • Behavioral: "personal diet advice"
Not Provided
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
48
May 2004
Not Provided

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
Both
20 Years to 55 Years
No
Contact information is only displayed when the study is recruiting subjects
Belgium
 
NCT00134290
2002/032
No
Not Provided
University Hospital, Ghent
Not Provided
Principal Investigator: Mimi Giri, MD, PhD University Hospital, Ghent
University Hospital, Ghent
December 2007

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP