- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT03204461
Glucose Metabolism in Different PCOS Phenotypes
June 27, 2017 updated by: Alexandra Kautzky-Willer, Medical University of Vienna
Associatons of PCOS Phenotypes With Ectopic Lipids, Adipocytokines and Parameters of Insulin Resistance
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.
Study Overview
Status
Completed
Intervention / Treatment
Detailed 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.
Study Type
Observational
Enrollment (Actual)
73
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
-
-
-
Vienna, Austria, 1090
- Medical University of Vienna
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-
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
20 years to 40 years (ADULT)
Accepts Healthy Volunteers
Yes
Genders Eligible for Study
Female
Sampling Method
Non-Probability Sample
Study Population
In the present study women with the Polycystic Ovary Syndrome, defined according to the NIH-criteria and the Rotterdam criteria were included.
The control Group consisted of healthy volunteers without a diagnosis of prediabetes, Diabetes or the PCOS.
Description
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 Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
Cohorts and Interventions
Group / Cohort |
Intervention / Treatment |
---|---|
Controls
|
For the assessment of glucose metabolism, including beta-cell function and insulin sensitivity an 75g-OGTT was conducted.
The amount of ectopic lipids in the liver, heart and the skeletal muscle was measured using 1H-magnetic resonance spectroscopy.
|
PCOS-NIH
|
For the assessment of glucose metabolism, including beta-cell function and insulin sensitivity an 75g-OGTT was conducted.
The amount of ectopic lipids in the liver, heart and the skeletal muscle was measured using 1H-magnetic resonance spectroscopy.
|
PCOS-Rotterdam
|
For the assessment of glucose metabolism, including beta-cell function and insulin sensitivity an 75g-OGTT was conducted.
The amount of ectopic lipids in the liver, heart and the skeletal muscle was measured using 1H-magnetic resonance spectroscopy.
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Comparison of glucose metabolism between PCOS women and healthy control subjects, using data of the OGTT.
Time Frame: Up to 4 weeks
|
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
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Publications and helpful links
The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start (ACTUAL)
December 3, 2012
Primary Completion (ACTUAL)
July 9, 2015
Study Completion (ACTUAL)
July 30, 2015
Study Registration Dates
First Submitted
June 26, 2017
First Submitted That Met QC Criteria
June 27, 2017
First Posted (ACTUAL)
July 2, 2017
Study Record Updates
Last Update Posted (ACTUAL)
July 2, 2017
Last Update Submitted That Met QC Criteria
June 27, 2017
Last Verified
June 1, 2017
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- PCOS-1090
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
No
Studies a U.S. FDA-regulated device product
No
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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