Health TrialsbyHealthPanel

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

This trial accepts healthy volunteers

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

Design model

Parallel

Treatments tested in this trial

  • Intervention Group

    Other intervention

    Short term comprehensive PCOS education coupled with lifestyle modification support

Treatment groups

40 Participants
are divided into 2 treatment groups
Group A: Standard of CareNo intervention 0 interventions
Group B: Intervention GroupExperimental treatment 1 intervention

Trial outcomes

Primary outcomes

1

Difference in Modified PCOS Health-related Quality of life questionnaire (mPCOSQ) scoring between participants.

Change in Polycystic ovarian Syndrome (PCOS) health-related quality of life assessed via the Modified PCOS Health-Related Quality of Life questionnaire (mPCOSQ) at two months and four months from baseline among intervention arm participants compared to controls. Scale Range: The instrument uses a 7-point scale, where lower scores (e.g., 1) represent a high negative impact on quality of life, and higher scores (e.g., 7) represent better quality of life.

Time frame
4 months

Secondary outcomes

1

Change in body composition analysis

Change in body composition analysis via seca mBCA (medical Body Composition Analyzer) at four months from baseline among intervention arm participants compared to controls.

Time frame
4 months
2

Change in visceral adiposity index (VAI)

Change in visceral adiposity index (VAI) via at four months from baseline among intervention arm participants compared to controls. A reliable indicator of visceral fat function associated with cardiometabolic risk. Sex-specific index, based on waist circumference, BMI, triglycerides, and HDL cholesterol, indirectly expressing visceral fat function.

Time frame
4 months
3

Change in fasting glucose, fasting insulin, c-reactive protein (CRP) at four months from baseline among intervention arm participants compared to controls.

Change in fasting glucose, fasting insulin, c-reactive protein (CRP) at four months from baseline among intervention arm participants compared to controls. Fasting glucose units - mg/dL Fasting insulin units - mU/mL C-reactive protein - mg/L

Time frame
4 months

Other outcomes

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

The Cleveland Clinic

Lead sponsor

American Academy of Family Physicians

Collaborator

Source ClinicalTrials.gov
Apply now