Status:
UNKNOWN
Glucose Evaluation Through Continuous Glucose Monitors in Polycystic Ovary Syndrome
Lead Sponsor:
University of California, San Francisco
Collaborating Sponsors:
DexCom, Inc.
Conditions:
PCOS (Polycystic Ovary Syndrome) of Bilateral Ovaries
Dysglycemia
Eligibility:
FEMALE
18-45 years
Phase:
NA
Brief Summary
PCOS is the most common endocrine disorder of reproductive aged women. In addition to menstrual and endocrine abnormalities, PCOS is characterized by insulin resistance and glycemic dysregulation. The...
Detailed Description
Study synopsis: Recruitment: * PCOS participants will be recruited from those who are being seen or have previously been seen at the UCSF multidisciplinary PCOS clinic. * Non-PCOS participants will ...
Eligibility Criteria
Inclusion
- For aim 1:
- Aged 18-45
- Female sex
- Agree to wear a CGM for 10 days
- Have access to an apple or android smart phone for CGM monitoring
- Are able to be characterized as PCOS or non-PCOS using the 2003 Rotterdam criteria for PCOS of 2 or more of the following: 1) biochemical or clinical hyperandrogenism, 2) polycystic ovarian morphology on transvaginal ultrasound, and/or 3) oligo-amenorrhea
- For aim 2:
- All of the inclusion criteria for aim 1
- Meet 2003 Rotterdam criteria for PCOS as above
- Evidence of baseline glycemic dysregulation including any of the following: 1) elevated fasting glucose (100-125 mg/dL), 2) elevated 2 hour glucose (140-200 mg/dL), 3) elevated fasting insulin (\>10 mIU/mL), 4) elevated 2 hour insulin (\>40 mIU/mL), 5) elevated Hgba1c (5.7- 6.4)
Exclusion
- For both aims 1 and 2:
- Use of metformin or other anti-diabetic agents
- Diagnosis of type I or II diabetes mellitus (including those found to have fasting glucose \>126, 2 hour glucose \>200, Hgba1c \>6.5)
- Prior or current use of CGM
Key Trial Info
Start Date :
November 29 2023
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
July 1 2025
Estimated Enrollment :
56 Patients enrolled
Trial Details
Trial ID
NCT06050265
Start Date
November 29 2023
End Date
July 1 2025
Last Update
November 18 2023
Active Locations (1)
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1
UCSF Center for Reproductive Health
San Francisco, California, United States, 94158