Glucose Evaluation Through Continuous Glucose Monitors in Polycystic Ovary Syndrome

RECRUITING

I'm interested ...!!

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 pattern of glycemic abnormalities among patients with PCOS may be different than the general population, as evidenced by invasive, time consuming, and costly procedures such as the euglycemic clamp or oral glucose tolerance test. Continuous glucose monitoring (CGM) offers an opportunity to evaluate glycemic status in real world conditions. Furthermore, use of a CGM has been found to improve glycemic status among those with prediabetes and diabetes, but little is known about utility among patients with PCOS. The investigators thus seek to 1) characterize glycemic status using CGM among patients with PCOS and 2) assess the impact of CGM use on metabolic and reproductive health in patients with PCOS.

Conditions:

🦠 PCOS (Polycystic Ovary Syndrome) of Bilateral Ovaries 🦠 Dysglycemia 🦠 Insulin Resistance

🗓️ Study Start (Actual) 29 November 2023

🗓️ Primary Completion (Estimated) July 2025

✅ Study Completion (Estimated) July 2025

👥 Enrollment (Estimated) 56

🔬 Study Type INTERVENTIONAL

📊 Phase NA

Locations:

📍 San Francisco, California, United States

📋 Eligibility Criteria

Description

Inclusion Criteria:

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 Criteria:

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

Ages Eligible for Study: 18 Years to 45 Years (ADULT)

Sexes Eligible for Study: FEMALE

Accepts Healthy Volunteers: Yes

🗓️ Study Record Dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Registration Dates

First Submitted 15 September 2023
First Submitted that Met QC Criteria 15 September 2023
First Posted 22 September 2023

Study Record Updates

Last Update Submitted that Met QC Criteria 15 November 2023
Last Update Posted 18 November 2023
Last Verified November 2023