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Physical Activity and Cardiometabolic Health in Women With or Without Polycystic Ovary Syndrome (SCOPAP)

Cardiometabolic Health in Women With Overweight or Obesity, With or Without Polycystic Ovary Syndrome: Effects of a Targeted Adapted Physical Activity Program

Status
Not yet recruiting
Phases
Unknown
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT07659392
Acronym
SCOPAP
Enrollment
40
Registered
2026-06-22
Start date
2026-07-01
Completion date
2028-12-01
Last updated
2026-06-22

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Overweight , Obesity, Poly Cystic Ovary Syndrome

Keywords

polycystic ovary syndrome, women, cardiometabolic, Physical activity

Brief 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. 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.

Interventions

BEHAVIORALPhysical activity

Participants will participate to adapted physical activity, supervised by a professional

Sponsors

University Hospital, Clermont-Ferrand
Lead SponsorOTHER
SMR Nutrition Obésité UGECAM
CollaboratorUNKNOWN
Laboratoire AME2P
CollaboratorUNKNOWN

Study design

Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
BASIC_SCIENCE
Masking
NONE

Intervention model description

The participants will have different conditions, with or without polycystic ovary syndrome, but will follow the same intervention

Eligibility

Sex/Gender
FEMALE
Age
18 Years to 40 Years
Healthy volunteers
No

Inclusion criteria

* 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

Exclusion criteria

* 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

Design outcomes

Primary

MeasureTime frame
Lipid oxidation during walking exerciseBaseline and after 10 weeks of intervention

Secondary

MeasureTime frame
Energy expenditure at restBaseline and after 10 weeks of intervention
Lipid oxidation at restBaseline and after 10 weeks of intervention
Carbohydrate oxidation at restBaseline and after 10 weeks of intervention
Systolic blood pressure at restBaseline and after 10 weeks of intervention
Diastolic blood pressure at restBaseline and after 10 weeks of intervention
Heart rate at restBaseline and after 10 weeks of intervention
Energy expenditure during walking exerciseBaseline and after 10 weeks of intervention
Energy cost of walkingBaseline and after 10 weeks of intervention
Carbohydrate oxidation during walking exerciseBaseline and after 10 weeks of intervention
Heart rate during walking exerciseBaseline and after 10 weeks of intervention
Fat massBaseline and after 10 weeks of intervention
Fat-free massBaseline and after 10 weeks of intervention
Body hydrationBaseline and after 10 weeks of intervention
Fasting glycemiaBaseline and after 10 weeks of intervention
Fasting insulin concentrationsBaseline and after 10 weeks of intervention
Fasting triglyceride concentrationsBaseline and after 10 weeks of intervention
Fasting LDL cholesterol concentrationsBaseline and after 10 weeks of intervention
Fasting HDL concentrationsBaseline and after 10 weeks of intervention
Fasting total cholesterol concentrationsBaseline and after 10 weeks of intervention
Fasting free-fatty acid concentrationsBaseline and after 10 weeks of intervention
Follicle-stimulating hormone concentrationsBaseline and after 10 weeks of intervention
Luteinizing hormone concentrationsBaseline and after 10 weeks of intervention
Estrogen concentrationsBaseline and after 10 weeks of intervention
Progesterone concentrationsBaseline and after 10 weeks of intervention
Total testosterone concentrationsBaseline and after 10 weeks of intervention
Free testosterone concentrationsBaseline and after 10 weeks of intervention
Fasting leptin concentrationsBaseline and after 10 weeks of intervention
Fasting adiponectin concentrationsBaseline and after 10 weeks of intervention
Time spent in sedentary behaviorsBaseline and after 10 weeks of intervention
Time spent in moderate-to-vigorous physical activityBaseline and after 10 weeks of intervention
Physical fitness-minute walking distanceBaseline and after 10 weeks of intervention
Right hand grip strengthBaseline and after 10 weeks of intervention
Left hand grip strengthBaseline and after 10 weeks of intervention
Number of repetitions during the 30-seconde chair stand testBaseline and after 10 weeks of intervention
Herat rate at the end of the step testBaseline and after 10 weeks of intervention
Heart rate 1 minute after the end of the step testBaseline and after 10 weeks of intervention
Heart rate 2 minutes after the end of the step testBaseline and after 10 weeks of intervention
Heart rate 3 minutes at the end of the step testBaseline and after 10 weeks of intervention

Countries

France

Contacts

CONTACTLise Laclautre
promo_interne_drci@chu-clermontferrand.fr+33473754963

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Jun 23, 2026