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

Study Overview
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Brief Summary
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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.

Detailed Description
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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.

Official Title
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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

Conditions
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Body Weight, Insulin Resistance

Intervention / Treatment
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* Drug: metformin
* Behavioral: standard diet advice
* Behavioral: personal diet advice


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 20 Years
Maximum Age: 55 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double


Arms and Interventions

| Intervention/Treatment |
| --- |
|Drug: metformin|nan|
|Behavioral: standard diet advice|nan|
|Behavioral: personal diet advice|nan|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Effect of diet on weight and insulin sensitivity/insulin resistance after 20 and 52 weeks of treatment |  |  | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Effect of metformin on weight and insulin resistance after 20 and 52 weeks of treatment |  |  |