Poly Cystic Ovary SyndromeSCOPAPNCT07659392
Physical Activity and Cardiometabolic Health in Women With or Without Polycystic Ovary Syndrome (SCOPAP)
A study testing Physical activity in people with Poly Cystic Ovary Syndrome and Overweight , Obesity, run by University Hospital, Clermont-Ferrand at 1 site in France.
Trial summary
The primary objective of this study is to investigate the effects of a multidisciplinary intervention, including a targeted adapted physical activity program, on lipid oxidation during a walking exercise in women with overweight or obesity, with or without polycystic ovary syndrome. Read more about this study
- Who is it for?
- Ages 18 to 40 years, women only
- Conditions the study is for
- Poly Cystic Ovary Syndrome, Overweight , Obesity
- What is being tested?
- Physical activity
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 40 participants
- Where
- 1 siteFrance
- Study dates
- Jul 2026to Dec 2028
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
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 40 years
- Women only
- No healthy volunteers
- Adult
Who may be able to join
- Women aged 18 to 40 years (inclusive boundaries)
- Women with a body mass index (BMI) between 25 and 40 kg/m²
- Women performing no more than 150 minutes of moderate-to-vigorous physical activity per week
- Women able to provide informed consent to participate
- Women affiliated with a social security system
- One group will consist of women with polycystic ovary syndrome, and another group will consist of women without polycystic ovary syndrome
Who cannot join
- Pregnancy or breastfeeding, as declared by the participant
- Postmenopausal women
- Women currently receiving pharmacological treatment for obesity or who have received such treatment within the past two years
- Women under legal protection measures (guardianship, curatorship, or judicial protection)
- Refusal to sign the informed consent form
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
France1 site
CHU de Clermont-Ferrand
Clermont-Ferrand, 63000
Lise Laclautre, +33473754963, promo_interne_drci@chu-clermontferrand.fr
About this study
Official title: Cardiometabolic Health in Women With Overweight or Obesity, With or Without Polycystic Ovary Syndrome: Effects of a Targeted Adapted Physical Activity Program
The primary objective of this study is to investigate the effects of a multidisciplinary intervention, including a targeted adapted physical activity program, on lipid oxidation during a walking exercise in women with overweight or obesity, with or without polycystic ovary syndrome. Specifically, the study aims to compare changes in lipid oxidation before and after the intervention between women with polycystic ovary syndrome and those without polycystic ovary syndrome.
The secondary objectives are to assess the impact of polycystic ovary syndrome on several physiological and metabolic parameters in women with overweight or obesity. These include: (i) resting energy metabolism; (ii) resting blood pressure and heart rate; (iii) energy expenditure, energy cost, and heart rate during a walking exercise; (iv) body composition, glycemic and lipid profiles, and circulating levels of sex hormones and adipokines; (v) movement behaviors; and (vi) physical fitness.
In addition, the effect of the multidisciplinary intervention, including the adapted physical activity program, will be evaluated on these same outcomes: (i) resting energy metabolism; (ii) resting blood pressure and heart rate; (iii) energy expenditure, energy cost, and heart rate during walking exercise; (iv) body composition, glycemic and lipid profiles, and concentrations of sex hormones and adipokines; (v) movement behaviors; and (vi) physical fitness, in women with overweight or obesity, with or without polycystic ovary syndrome.
- Conditions
- Poly Cystic Ovary Syndrome, Overweight , Obesity
- Being tested
- Physical activity
- Keywords
- polycystic ovary syndrome, women, cardiometabolic, Physical activity
- Medical subject headings
- Overweight, Obesity, Polycystic Ovary Syndrome, Motor Activity
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Physical activityBehavioural
Participants will participate to adapted physical activity, supervised by a professional
| Study group | Role | What they receive |
|---|---|---|
| Physical activity intervention | Experimental | Not described Receives: Behavioral: Physical activity |
What is being measured
The primary outcome is the main question the study is designed to answer.
Lipid oxidation during walking exercise
Measured: Baseline and after 10 weeks of intervention
Secondary outcomes (38)
Energy expenditure at rest
Measured: Baseline and after 10 weeks of intervention
Lipid oxidation at rest
Measured: Baseline and after 10 weeks of intervention
Carbohydrate oxidation at rest
Measured: Baseline and after 10 weeks of intervention
Systolic blood pressure at rest
Measured: Baseline and after 10 weeks of intervention
Diastolic blood pressure at rest
Measured: Baseline and after 10 weeks of intervention
Heart rate at rest
Measured: Baseline and after 10 weeks of intervention
Energy expenditure during walking exercise
Measured: Baseline and after 10 weeks of intervention
Energy cost of walking
Measured: Baseline and after 10 weeks of intervention
Carbohydrate oxidation during walking exercise
Measured: Baseline and after 10 weeks of intervention
Heart rate during walking exercise
Measured: Baseline and after 10 weeks of intervention
Fat mass
Measured: Baseline and after 10 weeks of intervention
Fat-free mass
Measured: Baseline and after 10 weeks of intervention
Body hydration
Measured: Baseline and after 10 weeks of intervention
Fasting glycemia
Measured: Baseline and after 10 weeks of intervention
Fasting insulin concentrations
Measured: Baseline and after 10 weeks of intervention
Fasting triglyceride concentrations
Measured: Baseline and after 10 weeks of intervention
Fasting LDL cholesterol concentrations
Measured: Baseline and after 10 weeks of intervention
Fasting HDL concentrations
Measured: Baseline and after 10 weeks of intervention
Fasting total cholesterol concentrations
Measured: Baseline and after 10 weeks of intervention
Fasting free-fatty acid concentrations
Measured: Baseline and after 10 weeks of intervention
Follicle-stimulating hormone concentrations
Measured: Baseline and after 10 weeks of intervention
Luteinizing hormone concentrations
Measured: Baseline and after 10 weeks of intervention
Estrogen concentrations
Measured: Baseline and after 10 weeks of intervention
Progesterone concentrations
Measured: Baseline and after 10 weeks of intervention
Total testosterone concentrations
Measured: Baseline and after 10 weeks of intervention
Free testosterone concentrations
Measured: Baseline and after 10 weeks of intervention
Fasting leptin concentrations
Measured: Baseline and after 10 weeks of intervention
Fasting adiponectin concentrations
Measured: Baseline and after 10 weeks of intervention
Time spent in sedentary behaviors
Measured: Baseline and after 10 weeks of intervention
Time spent in moderate-to-vigorous physical activity
Measured: Baseline and after 10 weeks of intervention
Physical fitness-minute walking distance
Measured: Baseline and after 10 weeks of intervention
Right hand grip strength
Measured: Baseline and after 10 weeks of intervention
Left hand grip strength
Measured: Baseline and after 10 weeks of intervention
Number of repetitions during the 30-seconde chair stand test
Measured: Baseline and after 10 weeks of intervention
Herat rate at the end of the step test
Measured: Baseline and after 10 weeks of intervention
Heart rate 1 minute after the end of the step test
Measured: Baseline and after 10 weeks of intervention
Heart rate 2 minutes after the end of the step test
Measured: Baseline and after 10 weeks of intervention
Heart rate 3 minutes at the end of the step test
Measured: Baseline and after 10 weeks of intervention
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted22 Jun 2026
- Study startJul 2026 (estimated)
- Primary completionDec 2028 (estimated)
- Study completionDec 2028 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Poly Cystic Ovary SyndromeStudies of the same condition, open and under way.
- More trials run by University Hospital, Clermont-FerrandThe sponsor's other registered studies.
- 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
- Not applicable
- Intervention model
- Single group
- Model description
- The participants will have different conditions, with or without polycystic ovary syndrome, but will follow the same intervention
- Masking
- None (open label)
- Enrolment
- 40 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University Hospital, Clermont-Ferrand
- Sponsor type
- University, hospital or other
- Collaborators
- SMR Nutrition Obésité UGECAM, Laboratoire des Adaptations Métaboliques à l'Exercice en conditions Physiologiques et Pathologiques
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07659392
- Sponsor's protocol ID
- RBHP 2026 BRUGNON
- Other IDs
- 2026-A00712-49
- Acronym
- SCOPAP
- Status last verified
- Jun 2026
- First submitted
- 11 Jun 2026
- Last updated
- 22 Jun 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: Internal regulation
Study at a glance
From the registry record, last updated by the sponsor on 22 Jun 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Cardiometabolic Health in Women With Overweight or Obesity, With or Without Polycystic Ovary Syndrome: Effects of a Targeted Adapted Physical Activity Program
- ClinicalTrials.gov ID
- NCT07659392
- Acronym / sponsor ID
- SCOPAP / RBHP 2026 BRUGNON
- Conditions
- Poly Cystic Ovary Syndrome, Overweight , Obesity
- Keywords
- polycystic ovary syndrome, women, cardiometabolic, Physical activity
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 40 participants (estimated)
- Lead sponsor
- University Hospital, Clermont-FerrandUniversity, hospital or other
- Collaborators
- SMR Nutrition Obésité UGECAM, Laboratoire des Adaptations Métaboliques à l'Exercice en conditions Physiologiques et Pathologiques
- Study start
- Jul 2026 (estimated)
- Primary completion
- Dec 2028 (estimated)
- Study completion
- Dec 2028 (estimated)
- First posted
- 22 Jun 2026 (actual)
- 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 primary objective of this study is to investigate the effects of a multidisciplinary intervention, including a targeted adapted physical activity program, on lipid oxidation during a walking exercise in women with overweight or obesity, with or without polycystic ovary syndrome. Specifically, the study aims to compare changes in lipid oxidation before and after the intervention between women with polycystic ovary syndrome and those without polycystic ovary syndrome.
The secondary objectives are to assess the impact of polycystic ovary syndrome on several physiological and metabolic parameters in women with overweight or obesity. These include: (i) resting energy metabolism; (ii) resting blood pressure and heart rate; (iii) energy expenditure, energy cost, and heart rate during a walking exercise; (iv) body composition, glycemic and lipid profiles, and circulating levels of sex hormones and adipokines; (v) movement behaviors; and (vi) physical fitness.
In addition, the effect of the multidisciplinary intervention, including the adapted physical activity program, will be evaluated on these same outcomes: (i) resting energy metabolism; (ii) resting blood pressure and heart rate; (iii) energy expenditure, energy cost, and heart rate during walking exercise; (iv) body composition, glycemic and lipid profiles, and concentrations of sex hormones and adipokines; (v) movement behaviors; and (vi) physical fitness, in women with overweight or obesity, with or without polycystic ovary syndrome.
Study design
- Primary purpose
- Basic science
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
- Model description
- The participants will have different conditions, with or without polycystic ovary syndrome, but will follow the same intervention
| Arm | Type | Receives |
|---|---|---|
| Physical activity intervention | Experimental | Behavioral: Physical activity |
Who may qualify
- Ages
- 18 to 40 years
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (6 listed)
- Women aged 18 to 40 years (inclusive boundaries)
- Women with a body mass index (BMI) between 25 and 40 kg/m²
- Women performing no more than 150 minutes of moderate-to-vigorous physical activity per week
- Women able to provide informed consent to participate
- Women affiliated with a social security system
Key exclusion criteria (5 listed)
- Pregnancy or breastfeeding, as declared by the participant
- Postmenopausal women
- Women currently receiving pharmacological treatment for obesity or who have received such treatment within the past two years
- Women under legal protection measures (guardianship, curatorship, or judicial protection)
- Refusal to sign the informed consent form
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 |
|---|---|---|
| Physical activityParticipants will participate to adapted physical activity, supervised by a professional | Behavioural | Physical activity intervention |
Primary outcome
Lipid oxidation during walking exercise
Time frame: Baseline and after 10 weeks of intervention
38 secondary outcomes
Energy expenditure at rest
Time frame: Baseline and after 10 weeks of intervention
Lipid oxidation at rest
Time frame: Baseline and after 10 weeks of intervention
Carbohydrate oxidation at rest
Time frame: Baseline and after 10 weeks of intervention
Systolic blood pressure at rest
Time frame: Baseline and after 10 weeks of intervention
Diastolic blood pressure at rest
Time frame: Baseline and after 10 weeks of intervention
Heart rate at rest
Time frame: Baseline and after 10 weeks of intervention
Energy expenditure during walking exercise
Time frame: Baseline and after 10 weeks of intervention
Energy cost of walking
Time frame: Baseline and after 10 weeks of intervention
Carbohydrate oxidation during walking exercise
Time frame: Baseline and after 10 weeks of intervention
Heart rate during walking exercise
Time frame: Baseline and after 10 weeks of intervention
Fat mass
Time frame: Baseline and after 10 weeks of intervention
Fat-free mass
Time frame: Baseline and after 10 weeks of intervention
Body hydration
Time frame: Baseline and after 10 weeks of intervention
Fasting glycemia
Time frame: Baseline and after 10 weeks of intervention
Fasting insulin concentrations
Time frame: Baseline and after 10 weeks of intervention
Fasting triglyceride concentrations
Time frame: Baseline and after 10 weeks of intervention
Fasting LDL cholesterol concentrations
Time frame: Baseline and after 10 weeks of intervention
Fasting HDL concentrations
Time frame: Baseline and after 10 weeks of intervention
Fasting total cholesterol concentrations
Time frame: Baseline and after 10 weeks of intervention
Fasting free-fatty acid concentrations
Time frame: Baseline and after 10 weeks of intervention
Follicle-stimulating hormone concentrations
Time frame: Baseline and after 10 weeks of intervention
Luteinizing hormone concentrations
Time frame: Baseline and after 10 weeks of intervention
Estrogen concentrations
Time frame: Baseline and after 10 weeks of intervention
Progesterone concentrations
Time frame: Baseline and after 10 weeks of intervention
Total testosterone concentrations
Time frame: Baseline and after 10 weeks of intervention
Free testosterone concentrations
Time frame: Baseline and after 10 weeks of intervention
Fasting leptin concentrations
Time frame: Baseline and after 10 weeks of intervention
Fasting adiponectin concentrations
Time frame: Baseline and after 10 weeks of intervention
Time spent in sedentary behaviors
Time frame: Baseline and after 10 weeks of intervention
Time spent in moderate-to-vigorous physical activity
Time frame: Baseline and after 10 weeks of intervention
Physical fitness-minute walking distance
Time frame: Baseline and after 10 weeks of intervention
Right hand grip strength
Time frame: Baseline and after 10 weeks of intervention
Left hand grip strength
Time frame: Baseline and after 10 weeks of intervention
Number of repetitions during the 30-seconde chair stand test
Time frame: Baseline and after 10 weeks of intervention
Herat rate at the end of the step test
Time frame: Baseline and after 10 weeks of intervention
Heart rate 1 minute after the end of the step test
Time frame: Baseline and after 10 weeks of intervention
Heart rate 2 minutes after the end of the step test
Time frame: Baseline and after 10 weeks of intervention
Heart rate 3 minutes at the end of the step test
Time frame: Baseline and after 10 weeks of intervention
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 22 Jun 2026.
- Individual participant dataSharing planned: No. Internal regulation
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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.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Physical activity in people with Poly Cystic Ovary Syndrome and Overweight , Obesity, run by University Hospital, Clermont-Ferrand at 1 site in France.
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 6 inclusion and 5 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: opening soon, as of the sponsor's last update on 22 Jun 2026. 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 France. 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?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Lise Laclautre (+33473754963, promo_interne_drci@chu-clermontferrand.fr), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Lipid oxidation during walking exercise (time frame: Baseline and after 10 weeks of intervention). 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 22 Jun 2026.