Status:
UNKNOWN
Glucose-Guided Eating Pilot
Lead Sponsor:
Georgetown University
Conditions:
Postmenopausal
Prediabetes
Eligibility:
All Genders
18+ years
Phase:
NA
Brief Summary
This is a single center, parallel-arm randomized controlled pilot study that aims to examine the feasibility and acceptability of the glucose-guided eating (GGE) mobile app and intervention in two pop...
Detailed Description
The primary objectives of the study are to (1) test the feasibility and acceptability of the GGE intervention and companion GGE mobile app and (2) quantify the preliminary effect of GGE on 12-week cha...
Eligibility Criteria
Inclusion
- All:
- Self-reported height and weight that is consistent with a BMI ≥ 27 kg/m2
- Willing to use a continuous glucose monitor
- Own smartphone that is compatible with Dexcom CGM.
- Willingness to commute to GUMC for in-person study visits
- No active cancer (except for nonmelanoma skin cancer)
- Less than 5 lbs. weight change in previous 3 months
- Proficient in speaking and reading English
- Postmenopausal women with pre-diabetes:
- Age 18 years and older
- Diagnosed as having prediabetes.
- HbA1c (within 3 months) between 5.7% and 6.4%
- Postmenopausal (defined as reporting no menstrual period for ≥1 year or a reported history of a total abdominal hysterectomy with oophorectomy)
- AYA cancer survivors:
- Current age 21-39 years
- Previously diagnosed with cancer, with all cancer-related diagnosis chemotherapy and/or radiation completed at least 6 months previously
Exclusion
- Unable or unwilling to provide informed consent
- Clinical history of type 1 or type 2 diabetes
- 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
- Current or past history of an eating disorder
- Self-identify as an overnight eater (defined as eating main meals between 9pm-5am)
- 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
- Growth hormone deficiency, hypoadrenal function, or hypopituitary function
Key Trial Info
Start Date :
January 2 2024
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
August 1 2025
Estimated Enrollment :
100 Patients enrolled
Trial Details
Trial ID
NCT05998460
Start Date
January 2 2024
End Date
August 1 2025
Last Update
December 21 2023
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