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OpenTrials
Completed

NCT Number: NCT02429128

14 Weeks Exercise Training on Lean Women With and Without PCOS

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.

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Key information

Conditions

Polycystic Ovary Syndrome (PCOS) Adnexal Diseases Cysts Endocrine System Diseases Female Urogenital Diseases Female Urogenital Diseases and Pregnancy Complications Genital Diseases Genital Diseases, Female Gonadal Disorders Neoplasms Ovarian Cysts Ovarian Diseases Polycystic Ovary Syndrome Urogenital Diseases

Age range

20 year–40 year

Sex eligibility

Female

Study type

Interventional

Phase

Not applicable

Primary location

August Krogh Building

Copenhagen, Østerbro, 2100, Denmark

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

14 weeks exercise training

Other

Primary outcomes

  1. 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%.

  2. No change in Body Weight

    Time frame: 14 weeks

  3. Component of metabolic syndrome

    Time frame: 14 weeks

    Hole body insulin sensitivity measured by HOMA index

  4. Component of metabolic syndrome

    Time frame: 14 weeks

    Peripheral insulin sensitivity measured by hyperinsulinemic euglycemic clamp methods.

Sponsors and collaborators

Lead sponsor

University of Copenhagen

Other

Registry information

Important dates

Study start
2014
Primary completion
2016
Study completion
2016
First posted
Apr 29, 2015
Registry last updated
Aug 3, 2016

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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