14 Weeks Exercise Training on Lean Women With and Without PCOS

Polycystic Ovary Syndrome (PCOS) Clinical Trial

Official title:

14 Weeks Exercise Training on Lean Women With and Without PCOS

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02429128
• Other study ID #: Lean PCOS & Training
• 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

Related Conditions & MeSH terms

• Polycystic Ovary Syndrome
• Polycystic Ovary Syndrome (PCOS)

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

External Links

•   Copenhagen Women Study - PCOS