Polycystic Ovary SyndromePOLYNCT01150539
Effects of Exercise for Overweight Women With Polycystic Ovary Syndrome
A study testing 16-week exercise training program in people with Polycystic Ovary Syndrome and Obesity, run by Pennington Biomedical Research Center at 1 site in United States.
Trial summary
The effects of a 16-week exercise training program on insulin resistance and adiposity in overweight/obese women with Polycystic ovary syndrome (PCOS). Read more about this study
- Who is it for?
- Ages 18 to 30 years, women only
- Conditions the study is for
- Polycystic Ovary Syndrome, Obesity
- What is being tested?
- 16-week exercise training program
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 8 participants
- Where
- 1 siteUnited States
- Study dates
- Jan 2007to Jun 2007
- 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 18 to 30 years
- Women only
- No healthy volunteers
- Adult
Who may be able to join
- Women between the ages of 18-30, inclusive.
- BMI greater than or equal to 25.
- Sedentary lifestyle - not currently exercising more than 60 minutes per week.
- A medical diagnosis of polycystic ovary syndrome. The diagnosis will be compared with the most recent international criteria1. Together with irregular menses (fewer than 6 cycles per year), participants must also have at least one of the following characteristics;
- presence of polycystic ovaries on transvaginal ultrasound, >10 cysts, 2-8 mm in diameter (ultrasound will not be done in this study however; ultrasound reports will be used if available) and/or
- clinical manifestations (hirsutism) examined by the PI at the screening visit or biochemical evidence (elevated testosterone or free androgen index) of hyperandrogenism, determined by fasting blood sample collected during the screening visit.
- Women enrolling for the non-PCOS control group are required to have regular menstrual cycles (one cycle per month).
Who cannot join
- Individuals with a history of cardiovascular disease or an elevated blood pressure above 160/90 mmHg.
- Individuals with a history of Diabetes (Type 1 or Type 2).
- Individuals with a history of Kidney, Liver or Heart disease.
- Individuals with untreated thyroid disease.
- Individuals who smoke.
- Individuals who exercise more than 60 minutes per week.
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- Individuals who use medications including contraceptives (medications used to treat thyroid disease are permitted).
- Individuals with alcoholism or other substance abuse.
- Individuals who are pregnant or lactating (breast feeding).
- Individuals who become pregnant throughout the study will be excluded.
- Individuals who are trying to become pregnant.
- Control subjects will be excluded if they have irregular menses (fewer than 1 cycle per month).
- Unable to complete approximately 60 minutes of medium intensity exercise per day (5 days per week) at the Pennington Health and Fitness Center (PCOS Group Only).
Trial locations and contacts
1 site in 1 country.
United States1 site
Pennington Biomedical Research Center
Baton Rouge, Louisiana, 70808
About this study
Official title: Effects of Physical Activity on Insulin Resistance and Adiposity in Polycystic Ovary Syndrome "Poly"
The effects of a 16-week exercise training program on insulin resistance and adiposity in overweight/obese women with Polycystic ovary syndrome (PCOS).
Read the detailed description
Young, overweight/obese women with PCOS along with age and BMI-matched healthy controls without PCOS will be enrolled in this study. Participants will have assessments of body composition (by DEXA), visceral and ectopic fat (by MR), ovarian parameters (follicle size and number, by MRI) insulin sensitivity (by euglycemic hyperinsulinemic clamp), interstitial lipolysis (by microdialysis), whole body lipolysis and glycolysis (by stable isotopes), aerobic fitness (by VO2max test) and a fat biopsy performed across two clinic visits (1 outpatient visit, and 1 overnight stay). Participants in the control group will undergo these assessments once only, whereas participants in the PCOS Group will have these assessments twice, once at baseline and once following a 16 week supervised aerobic exercise program. Throughout the exercise program body weight will be measured weekly and menstrual cycle frequency will be documented on a calendar. Additionally, vital signs, weight, waist and hip circumferences will be measured and a fasting blood sample collected every 4 weeks.
- Conditions
- Polycystic Ovary Syndrome, Obesity
- Being tested
- 16-week exercise training program, Control Group without PCOS
- Medical subject headings
- Polycystic Ovary Syndrome, Obesity
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
16-week exercise training programOther
The primary objective of the study is to investigate the effects of a 16-week exercise training program on insulin resistance and adiposity in overweight/obese women with PCOS.
Control Group without PCOSOther
A group of overweight/obese women without PCOS will be enrolled as a control group and will be studied only once at baseline to allow for comparisons between the two study populations.
| Study group | Role | What they receive |
|---|---|---|
| Overweight/obese women with PCOS | Experimental | 10 overweight/obese women with polycystic ovary syndrome Receives: Other: 16-week exercise training program; Other: Control Group without PCOS |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in Insulin sensitivity as measured by the euglycemic hyperinsulinemic clamp
16-weeks of aerobic exercise training on: peripheral insulin sensitivity (euglycemic-hyperinsulinemic clamp) and catecholamines (microdialysis) during a euglycemic-hyperinsulinemic clamp.
Measured: Baseline and 16-weeks
Secondary outcomes (1)
Change in adiposity (whole body measurement by dual x-ray absorptiometry and visceral measured by magnetic resonance imaging)
16-weeks of aerobic exercise training on total and free testosterone concentraions and frequency of menstruation, Body lipolysis, and visceral fat.
Measured: Baseline and 16-weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted25 Jun 2010 (estimated)
- Study startJan 2007
- Primary completionMay 2007
- Study completionJun 2007
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Polycystic Ovary SyndromeStudies 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
- Prevention
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 8 participants (actual)
Sponsor and investigators
- Lead sponsor
- Pennington Biomedical Research Center
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Leanne Redman, Pennington Biomedical Research Center
- Investigators
- Leanne Readman, PhD, Principal investigator, Pennington Biomedical Research Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01150539
- Sponsor's protocol ID
- PBRC 26038
- Acronym
- POLY
- Status last verified
- Aug 2021
- First submitted
- 22 Jun 2010
- Last updated
- 25 Aug 2021
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 25 Aug 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effects of Physical Activity on Insulin Resistance and Adiposity in Polycystic Ovary Syndrome "Poly"
- ClinicalTrials.gov ID
- NCT01150539
- Acronym / sponsor ID
- POLY / PBRC 26038
- Conditions
- Polycystic Ovary Syndrome, Obesity
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 8 participants (actual)
- Lead sponsor
- Pennington Biomedical Research CenterUniversity, hospital or other
- Study start
- Jan 2007
- Primary completion
- May 2007 (actual)
- Study completion
- Jun 2007 (actual)
- First posted
- 25 Jun 2010 (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 effects of a 16-week exercise training program on insulin resistance and adiposity in overweight/obese women with Polycystic ovary syndrome (PCOS).
Detailed description
Young, overweight/obese women with PCOS along with age and BMI-matched healthy controls without PCOS will be enrolled in this study. Participants will have assessments of body composition (by DEXA), visceral and ectopic fat (by MR), ovarian parameters (follicle size and number, by MRI) insulin sensitivity (by euglycemic hyperinsulinemic clamp), interstitial lipolysis (by microdialysis), whole body lipolysis and glycolysis (by stable isotopes), aerobic fitness (by VO2max test) and a fat biopsy performed across two clinic visits (1 outpatient visit, and 1 overnight stay). Participants in the control group will undergo these assessments once only, whereas participants in the PCOS Group will have these assessments twice, once at baseline and once following a 16 week supervised aerobic exercise program. Throughout the exercise program body weight will be measured weekly and menstrual cycle frequency will be documented on a calendar. Additionally, vital signs, weight, waist and hip circumferences will be measured and a fasting blood sample collected every 4 weeks.
Study design
- Primary purpose
- Prevention
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Overweight/obese women with PCOS | Experimental | Other: 16-week exercise training program, Other: Control Group without PCOS10 overweight/obese women with polycystic ovary syndrome |
Who may qualify
- Ages
- 18 to 30 years
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (7 listed)
- Women between the ages of 18-30, inclusive.
- BMI greater than or equal to 25.
- Sedentary lifestyle - not currently exercising more than 60 minutes per week.
- A medical diagnosis of polycystic ovary syndrome. The diagnosis will be compared with the most recent international criteria1. Together with irregular menses (fewer than 6 cycles per year), participants must also have at least one of the following characteristics;
- Women enrolling for the non-PCOS control group are required to have regular menstrual cycles (one cycle per month).
Key exclusion criteria (13 listed)
- Individuals with a history of cardiovascular disease or an elevated blood pressure above 160/90 mmHg.
- Individuals with a history of Diabetes (Type 1 or Type 2).
- Individuals with a history of Kidney, Liver or Heart disease.
- Individuals with untreated thyroid disease.
- Individuals who smoke.
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 |
|---|---|---|
| 16-week exercise training programThe primary objective of the study is to investigate the effects of a 16-week exercise training program on insulin resistance and adiposity in overweight/obese women with PCOS. | Other | Overweight/obese women with PCOS |
| Control Group without PCOSA group of overweight/obese women without PCOS will be enrolled as a control group and will be studied only once at baseline to allow for comparisons between the two study populations. | Other | Overweight/obese women with PCOS |
Primary outcome
Change in Insulin sensitivity as measured by the euglycemic hyperinsulinemic clamp
Time frame: Baseline and 16-weeks
16-weeks of aerobic exercise training on: peripheral insulin sensitivity (euglycemic-hyperinsulinemic clamp) and catecholamines (microdialysis) during a euglycemic-hyperinsulinemic clamp.
1 secondary outcome
Change in adiposity (whole body measurement by dual x-ray absorptiometry and visceral measured by magnetic resonance imaging)
Time frame: Baseline and 16-weeks
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 25 Aug 2021.
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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.
Leanne Readman, PhD principal investigator
Pennington Biomedical Research Center
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing 16-week exercise training program in people with Polycystic Ovary Syndrome and Obesity, run by Pennington Biomedical Research Center at 1 site in United States.
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 7 inclusion and 13 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 25 Aug 2021. 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 United States. 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?
Change in Insulin sensitivity as measured by the euglycemic hyperinsulinemic clamp (time frame: Baseline and 16-weeks). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 25 Aug 2021.