The Effects of Calorie Restriction With or Without Metformin on Weight and Insulin Resistance
NCT ID: NCT00134290
Last Updated: 2007-12-28
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
PHASE4
48 participants
INTERVENTIONAL
2002-01-31
2004-05-31
Brief Summary
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* 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.
Detailed Description
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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.
Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
DOUBLE
Interventions
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metformin
"standard diet advice"
"personal diet advice"
Eligibility Criteria
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Inclusion Criteria
* 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
* Hypogonadism with other etiology than overweight
* Pregnancy
* BMI equal to or greater than 40 kg/m²
20 Years
55 Years
ALL
No
Sponsors
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University Hospital, Ghent
OTHER
Principal Investigators
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Mimi Giri, MD, PhD
Role: PRINCIPAL_INVESTIGATOR
University Hospital, Ghent
Locations
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University Hospital Ghent
Ghent, , Belgium
Countries
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Related Links
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Website University Hospital Ghent
Other Identifiers
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2002/032
Identifier Type: -
Identifier Source: org_study_id