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

This study has been completed.
Sponsor:
Information provided by:
University Hospital, Ghent
ClinicalTrials.gov Identifier:
NCT00134290
First received: August 23, 2005
Last updated: December 19, 2007
Last verified: December 2007
  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 4

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double-Blind
Primary Purpose: Treatment
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

Resource links provided by NLM:


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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

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

Additional Information:
No publications provided

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

Additional relevant MeSH terms:
Body Weight
Insulin Resistance
Signs and Symptoms
Hyperinsulinism
Glucose Metabolism Disorders
Metabolic Diseases
Metformin
Hypoglycemic Agents
Physiological Effects of Drugs
Pharmacologic Actions

ClinicalTrials.gov processed this record on July 22, 2014