Glucose Metabolism in Different PCOS Phenotypes

NCT ID: NCT03204461

Last Updated: 2017-07-02

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

Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.

Recruitment Status

COMPLETED

Total Enrollment

73 participants

Study Classification

OBSERVATIONAL

Study Start Date

2012-12-03

Study Completion Date

2015-07-30

Brief Summary

Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.

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.

Detailed Description

Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.

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.

Conditions

See the medical conditions and disease areas that this research is targeting or investigating.

Polycystic Ovary Syndrome Glucose Intolerance Liver Fat Glucose Metabolism Disorders

Study Design

Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.

Observational Model Type

OTHER

Study Time Perspective

PROSPECTIVE

Study Groups

Review each arm or cohort in the study, along with the interventions and objectives associated with them.

PCOS-NIH

Oral glucose tolerance test (OGTT)

Intervention Type DIAGNOSTIC_TEST

For the assessment of glucose metabolism, including beta-cell function and insulin sensitivity an 75g-OGTT was conducted.

1H-magnetic resonance spectroscopy

Intervention Type OTHER

The amount of ectopic lipids in the liver, heart and the skeletal muscle was measured using 1H-magnetic resonance spectroscopy.

PCOS-Rotterdam

Oral glucose tolerance test (OGTT)

Intervention Type DIAGNOSTIC_TEST

For the assessment of glucose metabolism, including beta-cell function and insulin sensitivity an 75g-OGTT was conducted.

1H-magnetic resonance spectroscopy

Intervention Type OTHER

The amount of ectopic lipids in the liver, heart and the skeletal muscle was measured using 1H-magnetic resonance spectroscopy.

Controls

Oral glucose tolerance test (OGTT)

Intervention Type DIAGNOSTIC_TEST

For the assessment of glucose metabolism, including beta-cell function and insulin sensitivity an 75g-OGTT was conducted.

1H-magnetic resonance spectroscopy

Intervention Type OTHER

The amount of ectopic lipids in the liver, heart and the skeletal muscle was measured using 1H-magnetic resonance spectroscopy.

Interventions

Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.

Oral glucose tolerance test (OGTT)

For the assessment of glucose metabolism, including beta-cell function and insulin sensitivity an 75g-OGTT was conducted.

Intervention Type DIAGNOSTIC_TEST

1H-magnetic resonance spectroscopy

The amount of ectopic lipids in the liver, heart and the skeletal muscle was measured using 1H-magnetic resonance spectroscopy.

Intervention Type OTHER

Eligibility Criteria

Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.

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
Minimum Eligible Age

20 Years

Maximum Eligible Age

40 Years

Eligible Sex

FEMALE

Accepts Healthy Volunteers

Yes

Sponsors

Meet the organizations funding or collaborating on the study and learn about their roles.

Medical University of Vienna

OTHER

Sponsor Role lead

Responsible Party

Identify the individual or organization who holds primary responsibility for the study information submitted to regulators.

Alexandra Kautzky-Willer

Univ.Prof.Dr.

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

Learn about the lead researchers overseeing the trial and their institutional affiliations.

Alexandra Kautzky-Willer, Univ.Prof.Dr.

Role: PRINCIPAL_INVESTIGATOR

Department of Internal Medicine III, Clinical Division of Endocrinology and Metabolism, Unit of Gender Medicine, Medical University of Vienna

Locations

Explore where the study is taking place and check the recruitment status at each participating site.

Medical University of Vienna

Vienna, , Austria

Site Status

Countries

Review the countries where the study has at least one active or historical site.

Austria

References

Explore related publications, articles, or registry entries linked to this study.

Leutner M, Gobl C, Wolf P, Maruszczak K, Bozkurt L, Steinbrecher H, Just-Kukurova I, Ott J, Egarter C, Trattnig S, Kautzky-Willer A. Pericardial Fat Relates to Disturbances of Glucose Metabolism in Women with the Polycystic Ovary Syndrome, but Not in Healthy Control Subjects. Int J Endocrinol. 2018 Aug 7;2018:5406128. doi: 10.1155/2018/5406128. eCollection 2018.

Reference Type DERIVED
PMID: 30158974 (View on PubMed)

Other Identifiers

Review additional registry numbers or institutional identifiers associated with this trial.

PCOS-1090

Identifier Type: -

Identifier Source: org_study_id

More Related Trials

Additional clinical trials that may be relevant based on similarity analysis.

SGLT2 Inhibitors in Patients With PCOS
NCT04700839 COMPLETED PHASE4