- ICH GCP
- US Clinical Trials Registry
- Klinisk forsøg NCT00145392
Body Composition, Glucose Metabolism, Insulin Resistance and Gene Expression in Muscle Cells in Healthy Overweight Women
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.
Studieoversigt
Status
Betingelser
Undersøgelsestype
Tilmelding
Kontakter og lokationer
Studiesteder
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Funen
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Odense, Funen, Danmark, 5000
- Department of Endocrinology, Odense University Hospital
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Deltagelseskriterier
Berettigelseskriterier
Aldre berettiget til at studere
Tager imod sunde frivillige
Køn, der er berettiget til at studere
Beskrivelse
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
Studieplan
Hvordan er undersøgelsen tilrettelagt?
Design detaljer
Samarbejdspartnere og efterforskere
Sponsor
Datoer for undersøgelser
Studer store datoer
Studiestart
Primær færdiggørelse (Faktiske)
Studieafslutning (Faktiske)
Datoer for studieregistrering
Først indsendt
Først indsendt, der opfyldte QC-kriterier
Først opslået (Skøn)
Opdateringer af undersøgelsesjournaler
Sidste opdatering sendt (Skøn)
Sidste opdatering indsendt, der opfyldte kvalitetskontrolkriterier
Sidst verificeret
Mere information
Begreber relateret til denne undersøgelse
Yderligere relevante MeSH-vilkår
Andre undersøgelses-id-numre
- 005
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