The Effects of Calorie Restriction With or Without Metformin on Weight and Insulin Resistance - Full Text View

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	Intervention	Phase
Body Weight Insulin Resistance	Drug: metformin Behavioral: "standard diet advice" Behavioral: "personal diet advice"	Phase IV

MedlinePlus related topics:

Obesity

ChemIDplus related topics:

Insulin Metformin Metformin hydrochloride

U.S. FDA Resources

Study Type:	Interventional
Study Design:	Treatment, Randomized, Double-Blind, Placebo Control, Parallel Assignment, Efficacy Study

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

Further study details as provided by University Hospital, Ghent:

Primary Outcome Measures:

Effect of diet on weight and insulin sensitivity/insulin resistance after 20 and 52 weeks of treatment

Secondary Outcome Measures:

Effect of metformin on weight and insulin resistance after 20 and 52 weeks of treatment

Estimated Enrollment:	48
Study Start Date:	January 2002
Study Completion Date:	May 2004

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.

Eligibility

Ages Eligible for Study:	20 Years to 55 Years
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	No

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

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00134290

Locations


Belgium
	University Hospital Ghent
	Ghent, Belgium, 9000

Sponsors and Collaborators

University Hospital, Ghent

Investigators


Principal Investigator:	Mimi Giri, MD, PhD	University Hospital, Ghent

More Information

Website University Hospital Ghent This link exits the ClinicalTrials.gov site

Study ID Numbers:	2002/032
First Received:	August 23, 2005
Last Updated:	December 19, 2007
ClinicalTrials.gov Identifier:	NCT00134290
Health Authority:	Belgium: Ministry of Social Affairs, Public Health and the Environment