Health-Related Quality of Life and Metabolic Outcomes in PCOS
Recruiting · NCT07571915 · Interventional (participants receive a specific treatment) · Lead sponsor: The Cleveland Clinic
View the official record on ClinicalTrials.gov →Interventions studied
Intervention Group
What this trial is about
The primary outcome of interest is change in PCOS health-related quality of life, while the secondary outcome of interest is change in adiposity, cardiometabolic, and inflammation biomarkers.
Who can take part
Age range
18 Years to 49 Years
Sex
Female
Healthy volunteers
Yes - healthy volunteers may be accepted
Phase
Not applicable (e.g. observational or device study)
Study type
Interventional (participants receive a specific treatment)
Inclusion criteria
- Non-pregnant females ages 18-49 years
- Preexisting diagnoses of PCOS and obesity (body-mass index (BMI) equal or greater to 30 kg/m2) at enrollment
Exclusion criteria
- Patients who are pregnant or planning to become pregnant during the study period
- Patients currently or with recent participation (\< 12 months at the time of enrollment) in a PCOS-focused group
- Patients with documented monogenic obesity
- Patients with a diagnosis of any type of diabetes (with the exclusion of prediabetes)
- Patients on systemic glucocorticoid therapy \> 7 days at the time of enrollment
- Patients with any end-stage organ disease
- Patients without access to internet
- Patients requiring English language interpretation
- Any condition which, based on the investigator's medical judgment, would preclude patient ability to complete the study
Where it is running
1 location listed across 1 US state.
- Cleveland Clinic - Cleveland, Ohio, United States