Eligibility Module
The Eligibility Module contains detailed information about who can participate in the clinical trial. This includes eligibility criteria, age restrictions, gender requirements, healthy volunteer status, and study population descriptions, helping researchers understand who is eligible to participate in the study.
Eligibility Module path is as follows:
Study -> Protocol Section -> Eligibility Module
Eligibility Module
Ignite Creation Date:
2025-12-25 @ 2:09 AM
Ignite Modification Date:
2025-12-25 @ 2:09 AM
NCT ID:
NCT05998460
Eligibility Criteria:
Inclusion Criteria:
All:
1. Self-reported height and weight that is consistent with a BMI ≥ 27 kg/m2
2. Willing to use a continuous glucose monitor
3. Own smartphone that is compatible with Dexcom CGM.
4. Willingness to commute to GUMC for in-person study visits
5. No active cancer (except for nonmelanoma skin cancer)
6. Less than 5 lbs. weight change in previous 3 months
7. Proficient in speaking and reading English
Postmenopausal women with pre-diabetes:
8. Age 18 years and older
9. Diagnosed as having prediabetes.
10. HbA1c (within 3 months) between 5.7% and 6.4%
11. Postmenopausal (defined as reporting no menstrual period for ≥1 year or a reported history of a total abdominal hysterectomy with oophorectomy)
AYA cancer survivors:
12. Current age 21-39 years
13. Previously diagnosed with cancer, with all cancer-related diagnosis chemotherapy and/or radiation completed at least 6 months previously
Exclusion Criteria:
1. Unable or unwilling to provide informed consent
2. Clinical history of type 1 or type 2 diabetes
3. Currently receiving anti-diabetics (e.g., insulin, GLP1), oral hypoglycemic agent (e.g., metformin), oral corticosteroids, oral glucocorticoids, beta blockers, hydroxyurea, atypical antipsychotic agents (i.e., Olanzapine, Aripiprazole) or systemic progestin-only contraceptives
4. Current or past history of an eating disorder
5. Self-identify as an overnight eater (defined as eating main meals between 9pm-5am)
6. Have any contraindications for CGM, including: severe allergy to surgical adhesive, being on dialysis, receiving diathermy treatment, or scheduled CT scan or MRI during wear period
7. Growth hormone deficiency, hypoadrenal function, or hypopituitary function
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
18 Years
Study:
NCT05998460
Study Brief:
Protocol Section:
NCT05998460