RECRUITING

Glucose Evaluation Through Continuous Glucose Monitors in Polycystic Ovary Syndrome

Study Overview

This clinical trial focuses on testing the efficacy of different digital interventions to promote re-engagement in cancer-related long-term follow-up care for adolescent and young adult (AYA) survivors of childhood cancer.

Description

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.

Official Title

Glucose Evaluation Through Continuous Glucose Monitors in Polycystic Ovary Syndrome

Quick Facts

Study Start:2023-11-29
Study Completion:2025-07
Study Type:Not specified
Phase:Not Applicable
Enrollment:Not specified
Status:RECRUITING

Study ID

NCT06050265

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Ages Eligible for Study:18 Years to 45 Years
Sexes Eligible for Study:FEMALE
Accepts Healthy Volunteers:Yes
Standard Ages:ADULT
Inclusion CriteriaExclusion Criteria
  1. * Aged 18-45
  2. * Female sex
  3. * Agree to wear a CGM for 10 days
  4. * Have access to an apple or android smart phone for CGM monitoring
  5. * 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
  6. * All of the inclusion criteria for aim 1
  7. * Meet 2003 Rotterdam criteria for PCOS as above
  8. * 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)
  1. * Use of metformin or other anti-diabetic agents
  2. * Diagnosis of type I or II diabetes mellitus (including those found to have fasting glucose \>126, 2 hour glucose \>200, Hgba1c \>6.5)
  3. * Prior or current use of CGM

Contacts and Locations

Study Contact

Heather Huddleston, MD
CONTACT
415-885-3674
heather.huddleston@ucsf.edu

Principal Investigator

Heather G Huddleston, MD
PRINCIPAL_INVESTIGATOR
University of California, San Francisco

Study Locations (Sites)

UCSF Center for Reproductive Health
San Francisco, California, 94158
United States

Collaborators and Investigators

Sponsor: University of California, San Francisco

  • Heather G Huddleston, MD, PRINCIPAL_INVESTIGATOR, University of California, San Francisco

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

Study Start Date2023-11-29
Study Completion Date2025-07

Study Record Updates

Study Start Date2023-11-29
Study Completion Date2025-07

Terms related to this study

Keywords Provided by Researchers

  • continuous glucose monitor

Additional Relevant MeSH Terms

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