Obesity and Overweight |
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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.
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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 |
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| 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
Expected Total Enrollment: 10
Study start: September 2002; Study completion: January 2007
Last follow-up: December 2003; Data entry closure: December 2003
Eligibility
Accepts Healthy Volunteers
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
Dorte Glintborg, MD, Principal Investigator, Odense University Hospital
More Information
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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