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

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

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.

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

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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