Health-Related Quality of Life and Metabolic Outcomes in PCOS
ConditionPCOS (Polycystic Ovary Syndrome)
Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexFemale
Age18-49
SponsorThe Cleveland Clinic
About this trial
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.
Eligibility criteria
Qualifiers
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
Disqualifiers
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)
Trial design
Treatments tested in this trial
- Intervention Group
Treatment groups
40 Participants
are divided into 2 treatment groupsSponsors and collaborators
The Cleveland Clinic
Lead sponsor
American Academy of Family Physicians
Collaborator
Source ClinicalTrials.gov