The Supporting Understanding of PCOS Education and Research (SUPER) Study

Last updated: November 21, 2024
Sponsor: University of Michigan
Overall Status: Active - Recruiting

Phase

N/A

Condition

Reproductive Health

Polycystic Ovarian Syndrome

Treatment

DASH diet

Very low-carbohydrate diet

Clinical Study ID

NCT05452642
HUM00210749
1R01DK128205-01A1
  • Ages 21-45
  • Female

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.

Eligibility Criteria

Inclusion

Inclusion criteria:

  • Participants must have the following criteria:

  • oligomenorrhea-anovulation

  • spontaneous intermenstrual periods (if not on hormonal birth control orbirth control that alters menstrual cycle timing) of < 21 days or > 35days or a total of 8 or fewer menses per year

  • if on hormonal birth control or birth control that alters menstrual cycletiming, a history of irregular periods

  • and hyperandrogenism

  • If not on hormonal birth control or birth control that alters menstrualcycle timing: Total testosterone ≥ 35 ng/dL OR free testosterone > 4.0pg/ml OR free androgen index > 1.5 OR in-person scoring for hirsutism,based on the modified Ferriman-Gallwey score, if attending an in-personassessment or based on the self-assessment (if not attending an in-personassessment) with a score of ≥ 4 considered hirsutism;

  • If on hormonal birth control or birth control that alters menstrual cycletiming: Tests within the past 10 years showing the above or study team'sin-person assessment of hirsutism as above.

  • If no medical records to confirm (most recent test from within the last 10 years inrange), 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 internet

  • Ability to engage in light physical activity

  • Willingness to be randomized to either dietary approach

  • Measured HbA1c at baseline of 5.3%-9.0%

Exclusion

Exclusion criteria:

  • Primary

  • Patients with non-PCOS etiologies of anovulation and hyperandrogenism (Cushing's disease, thyroid dysfunction, elevated prolactin levels, signs of acongenital adrenal hyperplasia organic intracranial lesion like a pituitarytumor, or suspected adrenal or ovarian tumor secreting androgens)

  • Menopause or removal of the ovaries

  • history of type 1 diabetes

  • use of medications prescribed for weight loss or psychostimulants known toaffect weight

  • participation in another weight loss program or intervention

  • use of glucose lowering medications other than metformin or medications knownto affect metabolism, such as chronic oral corticosteroids

  • pregnant or planning to become pregnant during the intervention period

  • Breastfeeding or less than 6 months postpartum

  • previous bariatric surgery or planning to have bariatric surgery during thestudy period

  • Self-reported blood disorders that influence HbA1c, including frequent bloodtransfusions, phlebotomy, anemia, hemoglobinopathy, and polycythemia

  • Ability

  • inability to read, write, or speak English

  • inability to provide informed consent

  • adherence to a vegan or vegetarian diet

  • difficulty chewing or swallowing

  • no influence over what foods are purchased, prepared, and/or served orinability to follow dietary advice due to lack of money or other resources

  • above weight limit (500 lbs) for DEXA

  • self-report of alcohol or substance use disorder within the past 5 years,including current at-risk drinking based on an AUDIT score of 15 or higher (butthose who score a 15 or higher and have this criterion as their only reason forineligibility may be assessed by a clinical psychologist for alcohol usedisorder and if deemed to not have such a disorder would be eligible for thetrial)

  • Safety

  • Renal disease: BUN > 30 mg/dL or serum creatinine > 1.4 mg/dL in our screeningblood tests or history of kidney stones

  • untreated eating disorder or unstable serious mental illness (such asdepression (score of 20 or greater on the PHQ8), bipolar or schizophrenia withpsychosis)

  • use of warfarin

  • chronic kidney disease, stage 4 or higher

  • Any other concerning values in baseline labs (we will plan to send theparticipant to their PCP and allow the participant to return for laterenrollment if labs are no longer concerning) Examples:

  • triglycerides of 600 mg/dL or higher

  • baseline uncorrected thyroid disease: TSH < .45 mIU/ML or > 4.5 mIU/ML

  • potassium: any abnormal value

  • baseline aspartate aminotransferase (AST) or alanine aminotransferase (ALT) > 2 times normal

  • any condition for which the study team deems participation to be unsafe orinappropriate

Study Design

Total Participants: 214
Treatment Group(s): 2
Primary Treatment: DASH diet
Phase:
Study Start date:
August 15, 2022
Estimated Completion Date:
October 14, 2026

Connect with a study center

  • University of Michigan

    Ann Arbor, Michigan 48109
    United States

    Active - Recruiting

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