NCT03204461

Brief 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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
73

participants targeted

Target at P50-P75 for all trials

Timeline
Completed

Started Dec 2012

Typical duration for all trials

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

December 3, 2012

Completed
2.6 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

July 9, 2015

Completed
21 days until next milestone

Study Completion

Last participant's last visit for all outcomes

July 30, 2015

Completed
1.9 years until next milestone

First Submitted

Initial submission to the registry

June 26, 2017

Completed
6 days until next milestone

First Posted

Study publicly available on registry

July 2, 2017

Completed
Last Updated

July 2, 2017

Status Verified

June 1, 2017

Enrollment Period

2.6 years

First QC Date

June 26, 2017

Last Update Submit

June 27, 2017

Conditions

Outcome Measures

Primary Outcomes (1)

  • 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

Study Arms (3)

PCOS-NIH

Diagnostic Test: Oral glucose tolerance test (OGTT)Other: 1H-magnetic resonance spectroscopy

PCOS-Rotterdam

Diagnostic Test: Oral glucose tolerance test (OGTT)Other: 1H-magnetic resonance spectroscopy

Controls

Diagnostic Test: Oral glucose tolerance test (OGTT)Other: 1H-magnetic resonance spectroscopy

Interventions

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

ControlsPCOS-NIHPCOS-Rotterdam

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

ControlsPCOS-NIHPCOS-Rotterdam

Eligibility Criteria

Age20 Years - 40 Years
Sexfemale
Healthy VolunteersYes
Age GroupsAdult (18-64)
Sampling MethodNon-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.

You may qualify if:

  • Women with the polycystic ovary Syndrome defined according to the Rotterdam and the NIH-criteria
  • healthy control subjects

You may not qualify if:

  • BMI\>=40kg/m²
  • Diagnosis of Diabetes in the PCOS-Group
  • Diagnosis of Prediabetes or Diabetes in the control group

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Medical University of Vienna

Vienna, 1090, Austria

Location

Related Publications (1)

  • 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.

MeSH Terms

Conditions

Polycystic Ovary SyndromeGlucose IntoleranceFatty LiverGlucose Metabolism Disorders

Interventions

Glucose Tolerance TestProton Magnetic Resonance Spectroscopy

Condition Hierarchy (Ancestors)

Ovarian CystsCystsNeoplasmsOvarian DiseasesAdnexal DiseasesGenital Diseases, FemaleFemale Urogenital DiseasesFemale Urogenital Diseases and Pregnancy ComplicationsUrogenital DiseasesGenital DiseasesGonadal DisordersEndocrine System DiseasesHyperglycemiaMetabolic DiseasesNutritional and Metabolic DiseasesLiver DiseasesDigestive System Diseases

Intervention Hierarchy (Ancestors)

Blood Chemical AnalysisClinical Chemistry TestsClinical Laboratory TechniquesDiagnostic Techniques and ProceduresDiagnosisDiagnostic Techniques, EndocrineInvestigative TechniquesMagnetic Resonance SpectroscopySpectrum AnalysisChemistry Techniques, Analytical

Study Officials

  • Alexandra Kautzky-Willer, Univ.Prof.Dr.

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

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
observational
Observational Model
OTHER
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Univ.Prof.Dr.

Study Record Dates

First Submitted

June 26, 2017

First Posted

July 2, 2017

Study Start

December 3, 2012

Primary Completion

July 9, 2015

Study Completion

July 30, 2015

Last Updated

July 2, 2017

Record last verified: 2017-06

Locations