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Exercise for PCOS & Insulin Resistance
N/A
Waitlist Available
Led By Heather Huddleston, MD
Research Sponsored by University of California, San Francisco
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial Must have
Be between 18 and 65 years old
Timeline
Screening 3 weeks
Treatment Varies
Follow Up baseline, 4 weeks, 8 weeks
Awards & highlights
No Placebo-Only Group
Summary
This trial will test if a structured exercise program can help improve insulin resistance in women with polycystic ovary syndrome.
Who is the study for?
Women with PCOS and insulin resistance can join this study if they're in good physical shape, have a confirmed diagnosis of PCOS, and show signs of insulin resistance. They must not be pregnant or planning pregnancy soon, over 50 or under 18 years old, severely obese, smokers, or have certain health conditions like diabetes type 2.
What is being tested?
The trial is testing how feasible it is for women with PCOS to stick to an exercise program and what effects it has on their metabolism. Participants will do either vigorous exercise for 75 minutes weekly or moderate exercise for 150 minutes weekly.
What are the potential side effects?
Since the interventions involve physical activity, potential side effects may include muscle soreness, fatigue, joint pain or injury. The intensity of these side effects could vary based on individual fitness levels.
Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ baseline, 4 weeks, 8 weeks
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~baseline, 4 weeks, 8 weeks
Treatment Details
Study Objectives
Study objectives can provide a clearer picture of what you can expect from a treatment.Primary study objectives
Completed Days of Exercise
Drop-out Rate
Secondary study objectives
Androgens (Change in free/total testosterone)
Fasting Insulin
HDL Cholesterol
+5 moreAwards & Highlights
No Placebo-Only Group
All patients enrolled in this study will receive some form of active treatment.
Trial Design
2Treatment groups
Experimental Treatment
Group I: Vigorous ExerciseExperimental Treatment1 Intervention
High-intensity interval training for 15 minutes daily, 5 days per week for 8 weeks
Group II: Moderate ExerciseExperimental Treatment1 Intervention
Brisk walking for 30 minutes daily, 5 days per week for 8 weeks
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Vigorous Exercise
2012
N/A
~150
Moderate Exercise
2019
N/A
~140
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Who is running the clinical trial?
University of California, San FranciscoLead Sponsor
2,591 Previous Clinical Trials
14,901,546 Total Patients Enrolled
8 Trials studying Polycystic Ovary Syndrome
378 Patients Enrolled for Polycystic Ovary Syndrome
Heather Huddleston, MDPrincipal InvestigatorUniversity of California, San Francisco
6 Previous Clinical Trials
8,280 Total Patients Enrolled
4 Trials studying Polycystic Ovary Syndrome
100 Patients Enrolled for Polycystic Ovary Syndrome
Media Library
Eligibility Criteria:
This trial includes the following eligibility criteria:- You are younger than 18 or older than 50 years old.You have a very high body mass index (BMI).You are currently a smoker.You have uncontrolled high blood pressure, type 2 diabetes, or heart problems.You have a bone or muscle problem that would make it hard for you to do the exercises in the program.You have been diagnosed with PCOS according to the 2003 Rotterdam criteria.Your body has trouble using insulin, which is a hormone that helps control blood sugar levels.
Research Study Groups:
This trial has the following groups:- Group 1: Vigorous Exercise
- Group 2: Moderate Exercise
Awards:
This trial has 1 awards, including:- No Placebo-Only Group - All patients enrolled in this study will receive some form of active treatment.
Timeline:
This trial has the following timeline:- Screening: It may take up to 3 Weeks to process to see if you qualify in this trial.
- Treatment: The duration you will receive the treatment varies.
- Follow Ups: You may be asked to continue sharing information regarding the trial for 6 Months after you stop receiving the treatment.