Body Composition, Glucose Metabolism, Insulin Resistance and Gene Expression in Muscle Cells in Healthy Overweight Women
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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.
| 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 |
Eligibility| Ages Eligible for Study: | 18 Years to 45 Years |
| Genders Eligible for Study: | Female |
| Accepts Healthy Volunteers: | Yes |
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| Denmark | |
| Department of Endocrinology, Odense University Hospital | |
| Odense, Funen, Denmark, 5000 | |
| 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 Insulin Resistance Obesity Polycystic Ovary Syndrome Overweight Diabetes Mellitus Glucose Metabolism Disorders Metabolic Diseases Endocrine System Diseases Hyperinsulinism Overnutrition Nutrition Disorders Body Weight |
Signs and Symptoms 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 June 18, 2013