Polycystic Ovarian Syndrome (PCOS)
Conditions
Brief summary
The purpose of this study is to learn more about blood sugar control in polycystic ovarian syndrome. The patient will be asked to wear a continuous glucose monitor (CGM) device that is applied to the arm with a sensor or filament that goes under the skin to measure your sugar levels. The patient will wear this at certain time points throughout the study. There will have a total of 2 blood draws (about 1 tsp. of blood) at screening and the 6-month visit, a measure of the patients body muscle and fat (body composition), and fill out a questionnaire at the end of the first 3 months and 6 months. Study participation in the research will last about 6 months.
Interventions
DEVICEStelo glucose biosensor by Dexcom
Unblinded continuous glucose monitoring (CGM) system
Sponsors
The Cleveland Clinic
Study design
Observational model
COHORT
Time perspective
PROSPECTIVE
Eligibility
Sex/Gender
ALL
Age
18 Years to 45 Years
Healthy volunteers
No
Inclusion criteria
1. Adult 18-45 years old 2. Diagnosis of PCOS by usual clinical method such as by Rotterdam criteria 3. BMI \>25 kg/m2
Exclusion criteria
1. Currently on medications that can improve glucose levels such as metformin and glucagon-like receptor 1 agonists (GLP1RA) 2. Previously intake of above-mentioned medications but less than 3 months since last intake of metformin or less than 6 months since last intake of GLP1RA 3. Currently on insulin 4. Does not have Stelo-compatible phone 5. Fasting glucose \>100 mg/dL (because that is the cutoff for prediabetes) (either labs taken within a week after first visit or within 3 months before start of study 6. HbA1c \> 5.7% (because this is the cutoff for prediabetes) (either labs taken after screening visit or within 3 months before start of study) 7. History of anorexia or bulimia 8. Current or previous CGM use 9. Use of oral contraceptives at time of enrolment 10. Intent to become pregnant within 6 months (will need to terminate study if gets pregnant as glucose readings will be affected) 11. Menopausal women
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Continuous Glucose measure derived glucometrics | 6 months | To describe CGM-derived glucometrics in patients with PCOS before and after lifestyle modification and/or pharmacologic intervention. |
| Continuous Glucose measure derived glucometrics and Polycystic ovarian syndrome | 6 months | To explore associations between CGM-derived glucometrics and PCOS-related clinical markers such as anti-mullerian hormone (AMH), HbA1c, lipid levels, body mass index, and body composition. Associations between glucometrics and PCOS-related clinical markers will be evaluated using correlations, two-sample t-tests or Pearson chi-square tests, as appropriate. |
| Lifestyle behaviors | 6 months | To evaluate patient perception of CGM in influencing lifestyle behaviors. The survey includes 5 multiple choice questions and will be summarized using frequencies and percentages. |
Countries
United States
Outcome results
None listed