The Supporting Understanding of PCOS Education and Research (SUPER) Study
Study Details
Study Description
Brief 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.
| Condition or Disease | Intervention/Treatment | Phase |
|---|---|---|
|
N/A |
Study Design
Arms and Interventions
| Arm | Intervention/Treatment |
|---|---|
| Active Comparator: DASH diet 12-month DASH diet intervention with psychological support |
Behavioral: DASH diet
Participants in this arm will be taught a DASH diet plus psychological skills to support dietary adherence.
|
| Experimental: Very low-carbohydrate diet 12-month very low-carbohydrate diet intervention with psychological support |
Behavioral: Very low-carbohydrate diet
Participants in this arm will be taught a very low-carbohydrate diet plus psychological skills to support dietary adherence.
|
Outcome Measures
Primary Outcome Measures
- Change in HbA1c [0 to 12 months]
HbA1c levels will be measured by standard immunoturbidimetric assay methods and quality control measures at a Clinical Laboratory Improvement Amendments (CLIA) certified lab.
Secondary Outcome Measures
- Change in percent body weight loss [0-12 months]
- Change in glycemic variability [0 to 12 months]
This will be measured with an Abbott Libre Pro continuous glucose monitoring device on participants' upper arm and the information on the sensor is blinded to participants. The monitoring device will record participants' glucose levels in the interstitial fluid by a glucose oxidase method every 15 minutes, continuously for 14 days at each time point. The glucose variability and the proportion of time spent in the euglycemic (3-7.8 millimoles per litre (mmol/l)) and hyperglycemic (≥ 11.1 mmol/l for at least 15 minutes) states, following previous standards for interstitial glucose concentrations.
- Change in percent body fat on DEXA [0 to 12 months]
This will be measured by dual-energy X-ray absorptiometry scan
- Change in HbA1c [0 to 4 months]
HbA1c levels will be measured by standard immunoturbidimetric assay methods and quality control measures at a Clinical Laboratory Improvement Amendments (CLIA) certified lab.
Eligibility Criteria
Criteria
Inclusion criteria:
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Participants must have the following criteria:
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oligomenorrhea-anovulation
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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
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if on hormonal birth control or birth control that alters menstrual cycle timing, a history of irregular periods
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and hyperandrogenism
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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, with a score of ≥ 4 considered hirsutism;
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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.
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If no medical records to confirm (most recent test from within the last 10 years in range), tests for diagnosis will be ordered:
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total testosterone < 100 ng/dL,
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dehydroepiandrosterone sulfate (DHEAS) < 600 μg/dL,
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fasting 17-hydroxyprogesterone (17-OHP) level < 2.0 ng/mL,
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prolactin < 25 ng/ml),
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follicle-stimulating hormone (FSH) levels < 20 mIU/mL
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BMI 25-50 kg/m2 or 23-50 kg/m2 for Asians
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21-40 years old
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Access to internet
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Ability to engage in light physical activity
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Willingness to be randomized to either dietary approach
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Measured HbA1c at baseline of 5.3%-8.0%
Exclusion criteria:
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Primary
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Patients with non-PCOS etiologies of anovulation and hyperandrogenism (Cushing's disease, thyroid dysfunction, elevated prolactin levels, signs of a congenital adrenal hyperplasia organic intracranial lesion like a pituitary tumor, or suspected adrenal or ovarian tumor secreting androgens)
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Menopause or removal of the ovaries
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history of type 1 diabetes
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use of medications prescribed for weight loss or psychostimulants known to affect weight
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participation in another weight loss program or intervention
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use of glucose lowering medications other than metformin or medications known to affect metabolism, such as chronic oral corticosteroids
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pregnant or planning to become pregnant during the intervention period
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Breastfeeding or less than 6 months postpartum
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previous bariatric surgery or planning to have bariatric surgery during the study period
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Self-reported blood disorders that influence HbA1c, including frequent blood transfusions, phlebotomy, anemia, hemoglobinopathy, and polycythemia
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Ability
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inability to read, write, or speak English
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inability to provide informed consent
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adherence to a vegan or vegetarian diet
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difficulty chewing or swallowing
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no influence over what foods are purchased, prepared, and/or served or inability to follow dietary advice due to lack of money or other resources
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above weight limit (500 lbs) for DEXA
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self-report of alcohol or substance use disorder within the past 5 years, including current at-risk drinking based on an AUDIT-C score of 3 or higher
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Safety
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Renal disease: BUN > 30 mg/dL or serum creatinine > 1.4 mg/dL in our screening blood tests or history of kidney stones
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untreated eating disorder or unstable serious mental illness (such as depression (score of 20 or greater on the PHQ8), bipolar or schizophrenia with psychosis)
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use of warfarin
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chronic kidney disease, stage 4 or higher
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Any other concerning values in baseline labs (we will plan to send the participant to their PCP and allow the participant to return for later enrollment if labs are no longer concerning) Examples:
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triglycerides of 600 mg/dL or higher
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baseline uncorrected thyroid disease: TSH < .45 mIU/ML or > 4.5 mIU/ML
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potassium: any abnormal value
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baseline aspartate aminotransferase (AST) or alanine aminotransferase (ALT)
2 times normal
- any condition for which the study team deems participation to be unsafe or inappropriate
Contacts and Locations
Locations
| Site | City | State | Country | Postal Code | |
|---|---|---|---|---|---|
| 1 | University of Michigan | Ann Arbor | Michigan | United States | 48109 |
Sponsors and Collaborators
- University of Michigan
- National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)
Investigators
- Principal Investigator: Laura Saslow, PhD, University of Michigan
Study Documents (Full-Text)
None provided.More Information
Publications
None provided.- HUM00210749