14 Weeks Exercise Training on Lean Women With and Without PCOS

August 2, 2016 updated by: Solvejg Hansen, University of Copenhagen
The aim of this project is to investigate the pathophysiology of PCOS in regards to the metabolic profile including defects in insulin sensitivity in skeletal muscle and adipose tissue, and to investigate the effects of exercise training on these parameters.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

22

Phase

  • Not Applicable

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

  • Denmark
    • Østerbro
      • Copenhagen, Østerbro, Denmark, 2100
        • August Krogh Building

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

Description

Inclusion Criteria: Women with PCOS

  • Hyperandrogenism and/or hyperandrogenemia
  • Regular menstruation
  • Age: 20-40
  • Inactive or low physical activity level
  • Low to moderate fitness status

Inclusion Criteria: Women without PCOS

  • Normal levels of plasma androgens
  • Polycystic ovary and/or menstrual dysfunction
  • Age: 20-40
  • Inactive or low physical activity level
  • Low to moderate fitness status

Exclusion Criteria: Women with and without PCOS

  • Pregnancy or breast feeding
  • Smoking
  • Use of birth control pills 3 mo before enrolment

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

  • Primary Purpose: Basic Science
  • Allocation: Non-Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Active Comparator: Lean PCOS training
14 weeks exercise training
Other: 14 weeks exercise training
Other: Lean healthy controls
14 weeks exercise training
Other: 14 weeks exercise training

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Compliance to exercise training program as assessed by number of training sessions completed
Time Frame: 14 weeks
Superviced training program - no. of training sessions are noted by trainer. Compliance must be higher than 80%.
14 weeks
No change in Body Weight
Time Frame: 14 weeks
14 weeks
Component of metabolic syndrome
Time Frame: 14 weeks
Hole body insulin sensitivity measured by HOMA index
14 weeks
Component of metabolic syndrome
Time Frame: 14 weeks
Peripheral insulin sensitivity measured by hyperinsulinemic euglycemic clamp methods.
14 weeks

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

University of Copenhagen

Investigators

  • Study Director: Bente Kiens, Professor, NEXS, KU

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.

General Publications

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

July 1, 2014

Primary Completion (Actual)

July 1, 2016

Study Completion (Actual)

July 1, 2016

Study Registration Dates

First Submitted

April 15, 2015

First Submitted That Met QC Criteria

April 23, 2015

First Posted (Estimate)

April 29, 2015

Study Record Updates

Last Update Posted (Estimate)

August 3, 2016

Last Update Submitted That Met QC Criteria

August 2, 2016

Last Verified

August 1, 2016

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • Lean PCOS & Training

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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