Polycystic Ovary Syndrome (PCOS)NCT02429128
14 Weeks Exercise Training on Lean Women With and Without PCOS
A study testing 14 weeks exercise training in people with Polycystic Ovary Syndrome (PCOS), run by University of Copenhagen at 1 site in Denmark.
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. Read more about this study
- Who is it for?
- Ages 20 to 40 years, women onlyHealthy volunteers can take part
- Conditions the study is for
- Polycystic Ovary Syndrome (PCOS)
- What is being tested?
- 14 weeks exercise training
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 22 participants
- Where
- 1 siteDenmark
- Study dates
- Jul 2014to Jul 2016
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 20 to 40 years
- Women only
- Healthy volunteers accepted
- Adult
Who may be able to join
- 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
Show all 10Show fewer
- Polycystic ovary and/or menstrual dysfunction
- Age: 20-40
- Inactive or low physical activity level
- Low to moderate fitness status
Who cannot join
- Pregnancy or breast feeding
- Smoking
- Use of birth control pills 3 mo before enrolment
Trial locations and contacts
1 site in 1 country.
About this study
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.
- Conditions
- Polycystic Ovary Syndrome (PCOS)
- Being tested
- 14 weeks exercise training
- Keywords
- Polycystic Ovary Syndrome (PCOS)
- Medical subject headings
- Polycystic Ovary Syndrome
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
14 weeks exercise trainingOther
| Study group | Role | What they receive |
|---|---|---|
| Lean PCOS training | Active comparator | 14 weeks exercise training Receives: Other: 14 weeks exercise training |
| Lean healthy controls | Other | 14 weeks exercise training Receives: Other: 14 weeks exercise training |
What is being measured
The primary outcome is the main question the study is designed to answer.
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%.
Measured: 14 weeks
No change in Body Weight
Measured: 14 weeks
Component of metabolic syndrome
Hole body insulin sensitivity measured by HOMA index
Measured: 14 weeks
Component of metabolic syndrome
Peripheral insulin sensitivity measured by hyperinsulinemic euglycemic clamp methods.
Measured: 14 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted29 Apr 2015 (estimated)
- Study startJul 2014
- Primary completionJul 2016
- Study completionJul 2016
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Polycystic Ovary Syndrome (PCOS)Studies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Basic science
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 22 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Copenhagen
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Solvejg Hansen, University of Copenhagen
- Investigators
- Bente Kiens, Professor, Study director, NEXS, KU
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02429128
- Sponsor's protocol ID
- Lean PCOS & Training
- Status last verified
- Aug 2016
- First submitted
- 15 Apr 2015
- Last updated
- 3 Aug 2016
- Results posted
- No
- Data monitoring committee
- No
Publications
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.
PubMed 30544235
Study at a glance
From the registry record, last updated by the sponsor on 3 Aug 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- 14 Weeks Exercise Training on Lean Women With and Without PCOS
- ClinicalTrials.gov ID
- NCT02429128
- Acronym / sponsor ID
- Lean PCOS & Training
- Conditions
- Polycystic Ovary Syndrome (PCOS)
- Keywords
- Polycystic Ovary Syndrome (PCOS)
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 22 participants (actual)
- Lead sponsor
- University of CopenhagenUniversity, hospital or other
- Study start
- Jul 2014
- Primary completion
- Jul 2016 (actual)
- Study completion
- Jul 2016 (actual)
- First posted
- 29 Apr 2015 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Basic science
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Lean PCOS training | Active comparator | Other: 14 weeks exercise training14 weeks exercise training |
| Lean healthy controls | Other | Other: 14 weeks exercise training14 weeks exercise training |
Who may qualify
- Ages
- 20 to 40 years
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (10 listed)
- Hyperandrogenism and/or hyperandrogenemia
- Regular menstruation
- Age: 20-40
- Inactive or low physical activity level
- Low to moderate fitness status
Key exclusion criteria (3 listed)
- Pregnancy or breast feeding
- Smoking
- Use of birth control pills 3 mo before enrolment
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| 14 weeks exercise training | Other | Lean PCOS training, Lean healthy controls |
Primary outcome
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%.
No change in Body Weight
Time frame: 14 weeks
Component of metabolic syndrome
Time frame: 14 weeks
Hole body insulin sensitivity measured by HOMA index
Component of metabolic syndrome
Time frame: 14 weeks
Peripheral insulin sensitivity measured by hyperinsulinemic euglycemic clamp methods.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 3 Aug 2016.
- Derived from this study: PubMed 30544235Hansen 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.
- Copenhagen Women Study - PCOSLink provided by the sponsor.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Bente Kiens, Professor study director
NEXS, KU
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing 14 weeks exercise training in people with Polycystic Ovary Syndrome (PCOS), run by University of Copenhagen at 1 site in Denmark.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 10 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 3 Aug 2016. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Denmark. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Compliance to exercise training program as assessed by number of training sessions completed (time frame: 14 weeks). The study lists 4 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT02429128, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 3 Aug 2016.