Ignite Creation Date:
2024-05-05 @ 11:48 AM
Last Modification Date:
2024-10-26 @ 9:13 AM
Study NCT ID:
NCT00134290
Status:
COMPLETED
Last Update Posted:
2007-12-28
First Post:
2005-08-23
Brief Title:
The Effects of Calorie Restriction With or Without Metformin on Weight and Insulin Resistance
Sponsor:
University Hospital Ghent
Organization:
University Hospital Ghent
Study Overview
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
Status:
COMPLETED
Status Verified Date:
2007-12
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
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
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
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 Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None