The Supporting Understanding of PCOS Education and Research (SUPER) Study (NCT05452642) | Clinical Trial Compass
Active — Not RecruitingNot Applicable
The Supporting Understanding of PCOS Education and Research (SUPER) Study
United States223 participantsStarted 2022-08-15
Plain-language 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.
Who can participate
Age range21 Years – 45 Years
SexFEMALE
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Inclusion criteria:
* Participants must have the following criteria:
* oligomenorrhea-anovulation
* spontaneous intermenstrual periods (if not on hormonal birth control or birth control that alters menstrual cycle timing) of \< 21 days or \> 35 days or a total of 8 or fewer menses per year
* if on hormonal birth control or birth control that alters menstrual cycle timing, a history of irregular periods
* and hyperandrogenism
* If not on hormonal birth control or birth control that alters menstrual cycle timing: Total testosterone ≥ 35 ng/dL OR free testosterone \> 4.0 pg/ml OR free androgen index \> 1.5 OR in-person scoring for hirsutism, based on the modified Ferriman-Gallwey score, if attending an in-person assessment or based on the self-assessment (if not attending an in-person assessment) with a score of ≥ 4 considered hirsutism;
* If on hormonal birth control or birth control that alters menstrual cycle timing: Tests within the past 10 years showing the above or study team's in-person assessment of hirsutism as above.
* If no medical records to confirm (most recent test from within the last 10 years in range), tests for diagnosis will be ordered:
* total testosterone \< 100 ng/dL,
* dehydroepiandrosterone sulfate (DHEAS) \< 600 μg/dL,
* fasting 17-hydroxyprogesterone (17-OHP) level \< 2.0 ng/mL,
* prolactin \< 25 ng/ml),
* follicle-stimulating hormone (FSH) levels \< 20 mIU/mL
* BMI 25-50 kg/m2 or 23-50 kg/m2 for Asians
* Access to int…