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

This study has been completed.

Sponsored by: Odense University Hospital
Information provided by: Odense University Hospital
ClinicalTrials.gov Identifier: NCT00145392
  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 IV

MedlinePlus related topics:   Diabetes    Obesity   

Drug Information available for:   Insulin    Dextrose    Somatotropin    Somatropin   

U.S. FDA Resources

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

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

Please refer to this study by its ClinicalTrials.gov identifier: NCT00145392

Locations
Denmark, Funen
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


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

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

Study placed in the following topic categories:
Obesity
Metabolic Diseases
Gonadal Disorders
Diabetes Mellitus
Endocrine System Diseases
Overweight
Healthy
Ovarian Diseases
Cysts
Insulin
Genital Diseases, Female
Body Weight
Signs and Symptoms
Hyperinsulinism
Polycystic Ovary Syndrome
Diabetes Mellitus, Type 2
Nutrition Disorders
Overnutrition
Endocrinopathy
Insulin Resistance
Metabolic disorder
Glucose Metabolism Disorders
Ovarian Cysts

Additional relevant MeSH terms:
Neoplasms
Pathologic Processes
Disease
Syndrome
Adnexal Diseases

ClinicalTrials.gov processed this record on October 31, 2008




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