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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT02429128
Other study ID # Lean PCOS & Training
Secondary ID
Status Completed
Phase N/A
First received April 15, 2015
Last updated August 2, 2016
Start date July 2014
Est. completion date July 2016

Study information

Verified date August 2016
Source University of Copenhagen
Contact n/a
Is FDA regulated No
Health authority Denmark: Ethics Committee
Study type Interventional

Clinical Trial Summary

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.


Recruitment information / eligibility

Status Completed
Enrollment 22
Est. completion date July 2016
Est. primary completion date July 2016
Accepts healthy volunteers Accepts Healthy Volunteers
Gender Female
Age group 20 Years to 40 Years
Eligibility 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 Design

Allocation: Non-Randomized, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Basic Science


Intervention

Other:
14 weeks exercise training


Locations

Country Name City State
Denmark August Krogh Building Copenhagen Østerbro

Sponsors (1)

Lead Sponsor Collaborator
University of Copenhagen

Country where clinical trial is conducted

Denmark, 

Outcome

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