Body Composition, Glucose Metabolism, Insulin Resistance and Gene Expression in Muscle Cells in Healthy Overweight Women

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT00145392
Recruitment Status : Completed
First Posted : September 5, 2005
Last Update Posted : June 24, 2008
Information provided by:
Odense University Hospital

Brief Summary:

In this study, we will clarify the degree of insulin resistance and characterise muscle glucose metabolism and gene expression in a group of overweight healthy women. The study will clarify how overweight influences body glucose metabolism and thereby in the long-run increases the risk for developing type 2 diabetes. Moreover, the study may clarify why some overweight women develop hormone disorders and diabetes while others remain healthy.

The study is essential as many patients suffer from diseases aggravated by overweight. In addition, a genetic disposition for diabetes or polycystic ovary syndrome may give rise to the disease if the patient gains weight. It is therefore important that weight-matched control subjects are included in projects with overweight patients.

This clinical trial includes 10 overweight women with regular hormones and normal level of male sex hormone. The patients included must be healthy, take no medications influencing the study results. The subjects must take no contraceptive pills or receive any other hormone treatment.

In connection with the investigation, the following will be carried out on all patients: clinical examination, blood tests, hyperinsulinaemic euglycaemic clamp, muscle biopsies, bone scan.

The purpose of the study is to gain more knowledge of how overweight influences women's risk of developing hormone diseases and diabetes.

Condition or disease
Obesity Type 2 Diabetes Polycystic Ovary Syndrome

Study Type : Observational
Enrollment : 10 participants
Time Perspective: Prospective
Official Title: Body Composition, Glucose Metabolism, Insulin Resistance and Gene Expression in Muscle Cells in Healthy Overweight Women
Study Start Date : September 2002
Actual Primary Completion Date : January 2007
Actual Study Completion Date : December 2007

Resource links provided by the National Library of Medicine

Drug Information available for: Insulin
U.S. FDA Resources

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 45 Years   (Adult)
Sexes Eligible for Study:   Female
Accepts Healthy Volunteers:   Yes

Inclusion Criteria:

  • Regular menses, i.e. cyclus length 25-34 days
  • Premenopausal
  • Ferrimann-Gallway score < 2
  • BMI > 27 kg/m2
  • normal total testosterone value < 3.5 nmol/l

Exclusion Criteria:

  • Age <18 years
  • Contraceptive pills within the past 3 months
  • Postmenopausal (increased FSH)
  • Diabetes mellitus
  • Endocrine or other disease requiring treatment
  • Eating disorder or other psychiatric history
  • Drug use known to influence parameters investigated in this trial
  • Pregnancy

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT00145392

Department of Endocrinology, Odense University Hospital
Odense, Funen, Denmark, 5000
Sponsors and Collaborators
Odense University Hospital
Principal Investigator: Dorte Glintborg, MD Odense University Hospital

Responsible Party: Odense University Hospital Identifier: NCT00145392     History of Changes
Other Study ID Numbers: 005
First Posted: September 5, 2005    Key Record Dates
Last Update Posted: June 24, 2008
Last Verified: June 2008

Keywords provided by Odense University Hospital:
Polycystic ovary syndrome
growth hormone
insulin resistance
glucose metabolism

Additional relevant MeSH terms:
Insulin Resistance
Polycystic Ovary Syndrome
Body Weight
Signs and Symptoms
Glucose Metabolism Disorders
Metabolic Diseases
Ovarian Cysts
Ovarian Diseases
Adnexal Diseases
Genital Diseases, Female
Gonadal Disorders
Endocrine System Diseases
Hypoglycemic Agents
Physiological Effects of Drugs