Polycystic Ovary Syndrome (PCOS) Clinical Trial
Official title:
14 Weeks Exercise Training on Lean Women With and Without PCOS
Verified date | August 2016 |
Source | University of Copenhagen |
Contact | n/a |
Is FDA regulated | No |
Health authority | Denmark: Ethics Committee |
Study type | Interventional |
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.
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 |
Allocation: Non-Randomized, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Basic Science
Country | Name | City | State |
---|---|---|---|
Denmark | August Krogh Building | Copenhagen | Østerbro |
Lead Sponsor | Collaborator |
---|---|
University of Copenhagen |
Denmark,
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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