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

Insulin Resistance Clinical Trial

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00134290
• Other study ID #: 2002/032
• Status: Completed
• Phase: Phase 4
• First received: August 23, 2005
• Last updated: December 19, 2007
• Start date: January 2002
• Est. completion date: May 2004

Study information

• Verified date: December 2007
• Source: University Hospital, Ghent
• Contact: n/a
• Is FDA regulated: No
• Health authority: Belgium: Ministry of Social Affairs, Public Health and the Environment
• Study type: Interventional

Clinical Trial 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.

Description:

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 48
• Est. completion date: May 2004
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 20 Years to 55 Years

Eligibility

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

Study Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double-Blind, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Body Weight
• Insulin Resistance

Intervention

Drug:
• metformin

Behavioral:
• "standard diet advice"

• "personal diet advice"

Locations

Country	Name	City	State
Belgium	University Hospital Ghent	Ghent

Sponsors (1)

Lead Sponsor	Collaborator
University Hospital, Ghent

Country where clinical trial is conducted

Belgium, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Effect of diet on weight and insulin sensitivity/insulin resistance after 20 and 52 weeks of treatment
Secondary	Effect of metformin on weight and insulin resistance after 20 and 52 weeks of treatment

External Links

•   Website University Hospital Ghent