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

NCT ID: NCT00145392

Last Updated: 2008-06-24

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Total Enrollment

10 participants

Study Classification

OBSERVATIONAL

Study Start Date

2002-09-30

Study Completion Date

2007-12-31

Brief Summary

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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.

Detailed Description

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Conditions

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Obesity Type 2 Diabetes Polycystic Ovary Syndrome

Keywords

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Polycystic ovary syndrome growth hormone insulin resistance overweight glucose metabolism

Study Design

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Study Time Perspective

PROSPECTIVE

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Maximum Eligible Age

45 Years

Eligible Sex

FEMALE

Accepts Healthy Volunteers

Yes

Sponsors

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Odense University Hospital

OTHER

Sponsor Role lead

Responsible Party

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Odense University Hospital

Principal Investigators

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Dorte Glintborg, MD

Role: PRINCIPAL_INVESTIGATOR

Odense University Hospital

Locations

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Department of Endocrinology, Odense University Hospital

Odense, Funen, Denmark

Site Status

Countries

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Denmark

Other Identifiers

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005

Identifier Type: -

Identifier Source: org_study_id