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Clinical Trials/NCT00145392
NCT00145392
Completed
Not Applicable

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

Odense University Hospital1 site in 1 country10 target enrollmentSeptember 2002

Overview

Phase
Not Applicable
Intervention
Not specified
Conditions
Obesity
Sponsor
Odense University Hospital
Enrollment
10
Locations
1
Status
Completed
Last Updated
17 years ago

Overview

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.

Registry
clinicaltrials.gov
Start Date
September 2002
End Date
December 2007
Last Updated
17 years ago
Study Type
Observational
Sex
Female

Investigators

Eligibility 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

Outcomes

Primary Outcomes

Not specified

Study Sites (1)

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