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.
Study Overview
Status
Conditions
Intervention / Treatment
Detailed 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.
Study Type
Enrollment
Phase
- Phase 4
Contacts and Locations
Study Locations
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Ghent, Belgium, 9000
- University Hospital Ghent
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Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Description
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 Plan
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: Double
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
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Effect of diet on weight and insulin sensitivity/insulin resistance after 20 and 52 weeks of treatment
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Secondary Outcome Measures
Outcome Measure |
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Effect of metformin on weight and insulin resistance after 20 and 52 weeks of treatment
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Collaborators and Investigators
Sponsor
Investigators
- Principal Investigator: Mimi Giri, MD, PhD, University Hospital, Ghent
Publications and helpful links
Helpful Links
Study record dates
Study Major Dates
Study Start
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Estimate)
Study Record Updates
Last Update Posted (Estimate)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- 2002/032
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