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Body Composition, Glucose Metabolism, Insulin Resistance Adn Gene Expression in Muscle Cells in Healthy Overweight Women - Article


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Obesity and Overweight


Clinical Trial: Body Composition, Glucose Metabolism, Insulin Resistance Adn Gene Expression in Muscle Cells in Healthy Overweight Women

This study is no longer recruiting patients.

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;   Ovarian Cysts

Study Type: Observational
Study Design: Natural History, Cross-Sectional, Case Control, Prospective Study

Further Study Details: 

Expected Total Enrollment:  10

Study start: September 2002;  Study completion: January 2007
Last follow-up: December 2003;  Data entry closure: December 2003

Eligibility

Ages Eligible for Study:  18 Years   -   45 Years,  Genders Eligible for Study:  Female

Accepts Healthy Volunteers

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 parametrers investigated in this trial
  • Pregnancy

Location Information


Denmark, Funen
      Department of Endocrinology, Odense University Hospital, Odense,  Funen,  5000,  Denmark

Study chairs or principal investigators

Dorte Glintborg, MD,  Principal Investigator,  Odense University Hospital   

More Information

Study ID Numbers:  5
Last Updated:  September 2, 2005
Record first received:  September 2, 2005
ClinicalTrials.gov Identifier:  NCT00145392
Health Authority: Denmark: National Board of Health
ClinicalTrials.gov processed this record on 2005-09-13


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October 10, 2008



Page Updated: November 22, 2004
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