The Effects of Calorie Restriction With or Without Metformin on Weight and Insulin Resistance
Overview[ - collapse ][ - ]
| Purpose | 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. |
|---|---|
| Condition | Body Weight Insulin Resistance |
| Intervention | Drug: metformin Behavioral: "standard diet advice" Behavioral: "personal diet advice" |
| Phase | Phase 4 |
| Sponsor | University Hospital, Ghent |
| Responsible Party | University Hospital, Ghent |
| ClinicalTrials.gov Identifier | NCT00134290 |
| First Received | August 23, 2005 |
| Last Updated | December 19, 2007 |
| Last verified | December 2007 |
Tracking Information[ + expand ][ + ]
| First Received Date | August 23, 2005 |
|---|---|
| Last Updated Date | December 19, 2007 |
| Start Date | January 2002 |
| Estimated Primary Completion Date | May 2004 |
| Current Primary Outcome Measures | Effect of diet on weight and insulin sensitivity/insulin resistance after 20 and 52 weeks of treatment |
| Current Secondary Outcome Measures | Effect of metformin on weight and insulin resistance after 20 and 52 weeks of treatment |
Descriptive Information[ + expand ][ + ]
| Brief Title | The Effects of Calorie Restriction With or Without Metformin on Weight and Insulin Resistance |
|---|---|
| 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 |
| Brief 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. |
| 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 | Interventional |
| Study Phase | Phase 4 |
| Study Design | Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double-Blind, Primary Purpose: Treatment |
| Condition |
|
| Intervention | Drug: metformin Behavioral: "standard diet advice" Behavioral: "personal diet advice" |
| Study Arm (s) | Not Provided |
Recruitment Information[ + expand ][ + ]
| Recruitment Status | Completed |
|---|---|
| Estimated Enrollment | 48 |
| Estimated Completion Date | May 2004 |
| Estimated Primary Completion Date | Not Provided |
| Eligibility Criteria | 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 |
| Gender | Both |
| Ages | 20 Years |
| Accepts Healthy Volunteers | No |
| Contacts | Not Provided |
| Location Countries | Belgium |
Administrative Information[ + expand ][ + ]
| NCT Number | NCT00134290 |
|---|---|
| Other Study ID Numbers | 2002/032 |
| Has Data Monitoring Committee | No |
| Information Provided By | University Hospital, Ghent |
| Study Sponsor | University Hospital, Ghent |
| Collaborators | Not Provided |
| Investigators | Principal Investigator: Mimi Giri, MD, PhD University Hospital, Ghent |
| Verification Date | December 2007 |
Locations[ + expand ][ + ]
| University Hospital Ghent | Ghent, Belgium, 9000 |
|---|