Eligibility
18 - 65
Female
What conditions do you have?
Select
Study Summary
This research will test whether a Dietary Approaches to Stop Hypertension (DASH) or a very low-carbohydrate diet better improves outcomes like blood glucose control and body weight for adults with polycystic ovary syndrome. Participants will have screening (includes blood draw) and baseline testing with a continuous glucose monitor and a body composition scan (called a dual-energy x-ray absorptiometry or DEXA). Once these enrollment steps are completed and the participants will be randomized to one of two 12-month programs.
Eligible Conditions
- Sclerocystic Ovaries
- Polycystic Ovarian Syndrome (PCOS)
Treatment Effectiveness
Effectiveness Progress
Other trials for Sclerocystic Ovaries
Study Objectives
0 Primary · 4 Secondary · Reporting Duration: 0-12 months
0 to 12 months
Change in glycemic variability
Change in percent body fat on DEXA
0 to 4 months
Change in HbA1c
0-12 months
Change in percent body weight loss
Trial Safety
Safety Progress
Other trials for Sclerocystic Ovaries
Trial Design
2 Treatment Groups
DASH diet
1 of 2
Very low-carbohydrate diet
1 of 2
Active Control
Experimental Treatment
184 Total Participants · 2 Treatment Groups
Primary Treatment: Very low-carbohydrate diet · No Placebo Group · N/A
Very low-carbohydrate diet
Behavioral
Experimental Group · 1 Intervention: Very low-carbohydrate diet · Intervention Types: BehavioralDASH diet
Behavioral
ActiveComparator Group · 1 Intervention: DASH diet · Intervention Types: BehavioralTrial Logistics
Trial Timeline
Approximate Timeline
Screening: ~3 weeks
Treatment: Varies
Reporting: 0-12 months
Trial Background
Prof. Laura Saslow, Assistant Professor
Principal Investigator
University of Michigan
Closest Location: University of Michigan · Ann Arbor, MI
2022First Recorded Clinical Trial
0 TrialsResearching Sclerocystic Ovaries
1003 CompletedClinical Trials
Eligibility Criteria
Age 18 - 65 · Female Participants · 10 Total Inclusion Criteria
Mark “yes” if the following statements are true for you:You have oligomenorrhea-anovulation.
You are on hormonal birth control or birth control that alters menstrual cycle timing, a history of irregular periods.
You are on hormonal birth control or birth control that alters menstrual cycle timing
You have low testosterone levels.\n
You have a menstrual period of < 21 days or > 35 days or a total of 8 or fewer menses per year.
DHEAS < 600 μg/dL.
About The Reviewer
Michael Gill holds a Bachelors of Science in Integrated Science and Mathematics from McMaster University. During his degree he devoted considerable time modeling the pharmacodynamics of promising drug candidates. Since then, he has leveraged this knowledge of the investigational new drug ecosystem to help his father navigate clinical trials for multiple myeloma, an experience which prompted him to co-found Power Life Sciences: a company that helps patients access randomized controlled trials.
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