NCT02429128

Brief 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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
22

participants targeted

Target at below P25 for not_applicable

Timeline
Completed

Started Jul 2014

Typical duration for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

July 1, 2014

Completed
10 months until next milestone

First Submitted

Initial submission to the registry

April 15, 2015

Completed
14 days until next milestone

First Posted

Study publicly available on registry

April 29, 2015

Completed
1.2 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

July 1, 2016

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

July 1, 2016

Completed
Last Updated

August 3, 2016

Status Verified

August 1, 2016

Enrollment Period

2 years

First QC Date

April 15, 2015

Last Update Submit

August 2, 2016

Conditions

Polycystic Ovary Syndrome (PCOS)

Keywords

Polycystic Ovary Syndrome (PCOS)

Outcome Measures

Primary Outcomes (4)

  • 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 change in Body Weight

    14 weeks

  • Component of metabolic syndrome

    Hole body insulin sensitivity measured by HOMA index

    14 weeks

  • Component of metabolic syndrome

    Peripheral insulin sensitivity measured by hyperinsulinemic euglycemic clamp methods.

    14 weeks

Study Arms (2)

Lean PCOS training

ACTIVE COMPARATOR

14 weeks exercise training

Other: 14 weeks exercise training

Lean healthy controls

OTHER

14 weeks exercise training

Other: 14 weeks exercise training

Interventions

14 weeks exercise trainingOTHER
Lean PCOS trainingLean healthy controls

Eligibility Criteria

Age20 Years - 40 Years
Sexfemale
Healthy VolunteersYes
Age GroupsAdult (18-64)

You may qualify if:

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

You may not qualify if:

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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

August Krogh Building

Copenhagen, Østerbro, 2100, Denmark

Location

Related Publications (1)

  • Hansen SL, Svendsen PF, Jeppesen JF, Hoeg LD, Andersen NR, Kristensen JM, Nilas L, Lundsgaard AM, Wojtaszewski JFP, Madsbad S, Kiens B. Molecular Mechanisms in Skeletal Muscle Underlying Insulin Resistance in Women Who Are Lean With Polycystic Ovary Syndrome. J Clin Endocrinol Metab. 2019 May 1;104(5):1841-1854. doi: 10.1210/jc.2018-01771.

    PMID: 30544235DERIVED

MeSH Terms

Conditions

Polycystic Ovary Syndrome

Interventions

Exercise

Condition Hierarchy (Ancestors)

Ovarian CystsCystsNeoplasmsOvarian DiseasesAdnexal DiseasesGenital Diseases, FemaleFemale Urogenital DiseasesFemale Urogenital Diseases and Pregnancy ComplicationsUrogenital DiseasesGenital DiseasesGonadal DisordersEndocrine System Diseases

Intervention Hierarchy (Ancestors)

Motor ActivityMovementMusculoskeletal Physiological PhenomenaMusculoskeletal and Neural Physiological Phenomena

Study Officials

  • Bente Kiens, Professor

    NEXS, KU

    STUDY DIRECTOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NON RANDOMIZED
Masking
NONE
Purpose
BASIC SCIENCE
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Cand Scient Human Physiology

Study Record Dates

First Submitted

April 15, 2015

First Posted

April 29, 2015

Study Start

July 1, 2014

Primary Completion

July 1, 2016

Study Completion

July 1, 2016

Last Updated

August 3, 2016

Record last verified: 2016-08

Locations

DK(1)