NCT00134290

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
48

participants targeted

Target at P25-P50 for phase_4

Timeline
Completed

Started Jan 2002

Typical duration for phase_4

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

January 1, 2002

Completed
2.3 years until next milestone

Study Completion

Last participant's last visit for all outcomes

May 1, 2004

Completed
1.3 years until next milestone

First Submitted

Initial submission to the registry

August 23, 2005

Completed
1 day until next milestone

First Posted

Study publicly available on registry

August 24, 2005

Completed
Last Updated

December 28, 2007

Status Verified

December 1, 2007

First QC Date

August 23, 2005

Last Update Submit

December 19, 2007

Conditions

Body WeightInsulin Resistance

Outcome Measures

Primary Outcomes (1)

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

Secondary Outcomes (1)

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

Interventions

metforminDRUG
"standard diet advice"BEHAVIORAL
"personal diet advice"BEHAVIORAL

Eligibility Criteria

Age20 Years - 55 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64)

You may qualify if:

  • 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

You may not qualify if:

  • Diabetes mellitus, kidney insufficiency, or hepatic insufficiency
  • Hypogonadism with other etiology than overweight
  • Pregnancy
  • BMI equal to or greater than 40 kg/m²

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

University Hospital Ghent

Ghent, 9000, Belgium

Location

Related Links

MeSH Terms

Conditions

Body WeightInsulin Resistance

Interventions

Metformin

Condition Hierarchy (Ancestors)

Signs and SymptomsPathological Conditions, Signs and SymptomsHyperinsulinismGlucose Metabolism DisordersMetabolic DiseasesNutritional and Metabolic Diseases

Intervention Hierarchy (Ancestors)

BiguanidesGuanidinesAmidinesOrganic Chemicals

Study Officials

  • Mimi Giri, MD, PhD

    University Hospital, Ghent

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
phase 4
Allocation
RANDOMIZED
Masking
DOUBLE
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER

Study Record Dates

First Submitted

August 23, 2005

First Posted

August 24, 2005

Study Start

January 1, 2002

Study Completion

May 1, 2004

Last Updated

December 28, 2007

Record last verified: 2007-12

Locations

BE(1)