Phase
Condition
Reproductive Health
Polycystic Ovarian Syndrome
Treatment
DASH diet
Very low-carbohydrate diet
Clinical Study ID
Ages 21-45 Female
Study Summary
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
Connect with a study center
University of Michigan
Ann Arbor, Michigan 48109
United StatesActive - Recruiting
Not the study for you?
Let us help you find the best match. Sign up as a volunteer and receive email notifications when clinical trials are posted in the medical category of interest to you.