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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT03204461
Other study ID # PCOS-1090
Secondary ID
Status Completed
Phase N/A
First received June 26, 2017
Last updated June 27, 2017
Start date December 3, 2012
Est. completion date July 30, 2015

Study information

Verified date June 2017
Source Medical University of Vienna
Contact n/a
Is FDA regulated No
Health authority
Study type Observational

Clinical Trial Summary

In the present study glucose metabolism and ectopic lipids in the liver, heart and muscle were investigated in women with the polycystic ovary syndrome (PCOS) and in healthy control subjects.


Description:

In detail an oral glucose tolerance test (OGTT) was conducted in women with the PCOS defined by the Rotterdam and the NIH-criteria, as well as in healthy control subjects. In addition 1H-magnetic resonance spectroscopy and Imaging was used for the assessment of the ectopic lipid content in the liver, heart and skeletal muscle. The aim of the present study was to compare the glucose metabolism and the ectopic lipid conent in the liver, heart and muscle between women with the PCOS defined by the NIH-criteria, Rotterdam-criteria and healthy control subjects.


Recruitment information / eligibility

Status Completed
Enrollment 73
Est. completion date July 30, 2015
Est. primary completion date July 9, 2015
Accepts healthy volunteers Accepts Healthy Volunteers
Gender Female
Age group 20 Years to 40 Years
Eligibility Inclusion Criteria:

- Women with the polycystic ovary Syndrome defined according to the Rotterdam and the NIH-criteria

- healthy control subjects

Exclusion Criteria:

- BMI>=40kg/m²

- Diagnosis of Diabetes in the PCOS-Group

- Diagnosis of Prediabetes or Diabetes in the control group

Study Design


Intervention

Diagnostic Test:
Oral glucose tolerance test (OGTT)
For the assessment of glucose metabolism, including beta-cell function and insulin sensitivity an 75g-OGTT was conducted.
Other:
1H-magnetic resonance spectroscopy
The amount of ectopic lipids in the liver, heart and the skeletal muscle was measured using 1H-magnetic resonance spectroscopy.

Locations

Country Name City State
Austria Medical University of Vienna Vienna

Sponsors (1)

Lead Sponsor Collaborator
Medical University of Vienna

Country where clinical trial is conducted

Austria, 

Outcome

Type Measure Description Time frame Safety issue
Primary Comparison of glucose metabolism between PCOS women and healthy control subjects, using data of the OGTT. In the present study the Glucose metabolism in PCOS women and control subjects was assessed with an OGTT. Therefore the dynamic levels of glucose, insulin and C-peptide were assessed during an extended OGTT for the calculation of Insulin resistance and beta-cell function. In addition an 1H-magnetic resonance spectroscopy was done for the assessment of the ectopic lipid content in the liver, heart and the skeletal muscle. Up to 4 weeks
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