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

This study has been completed.
Sponsor:
Information provided by:
Odense University Hospital
ClinicalTrials.gov Identifier:
NCT00145392
First received: September 2, 2005
Last updated: June 23, 2008
Last verified: June 2008
  Purpose

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 Phase
Obesity
Type 2 Diabetes
Polycystic Ovary Syndrome
Phase 4

Study Type: Observational
Study Design: Time Perspective: Prospective
Official Title: Body Composition, Glucose Metabolism, Insulin Resistance and Gene Expression in Muscle Cells in Healthy Overweight Women

Resource links provided by NLM:


Further study details as provided by Odense University Hospital:

Estimated Enrollment: 10
Study Start Date: September 2002
Study Completion Date: December 2007
Primary Completion Date: January 2007 (Final data collection date for primary outcome measure)
  Eligibility

Ages Eligible for Study:   18 Years to 45 Years
Genders Eligible for Study:   Female
Accepts Healthy Volunteers:   Yes
Criteria

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
  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: NCT00145392

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

No publications provided

Responsible Party: Odense University Hospital
ClinicalTrials.gov Identifier: NCT00145392     History of Changes
Other Study ID Numbers: 005
Study First Received: September 2, 2005
Last Updated: June 23, 2008
Health Authority: Denmark: National Board of Health

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

Additional relevant MeSH terms:
Diabetes Mellitus, Type 2
Syndrome
Overweight
Insulin Resistance
Polycystic Ovary Syndrome
Diabetes Mellitus
Glucose Metabolism Disorders
Metabolic Diseases
Endocrine System Diseases
Disease
Pathologic Processes
Body Weight
Signs and Symptoms
Hyperinsulinism
Ovarian Cysts
Cysts
Neoplasms
Ovarian Diseases
Adnexal Diseases
Genital Diseases, Female
Gonadal Disorders
Insulin
Hypoglycemic Agents
Physiological Effects of Drugs
Pharmacologic Actions

ClinicalTrials.gov processed this record on September 18, 2014