Clinical trial NCT05998460: Glucose-Guided Eating Pilot
Official title: Glucose-Guided Eating to Reduce Chronic Disease Risk: a Pilot Study
Study type: INTERVENTIONAL
Overall status: NOT_YET_RECRUITING
Phase: NA
Conditions: Postmenopausal
Prediabetes
Adolescent and Young Adult (AYA) Cancer Survivors
Lead sponsor: Georgetown University
Sponsor class: OTHER
First posted: 2023-08-21
Enrollment: 100
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

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 populations at risk of chronic disease (postmenopausal women with prediabetes and AYA cancer survivors).

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 changes in insulin resistance (IR) and body weight.

The secondary objectives of the study are to (1) collect preliminary data on hypothesized mechanisms linking GGE to IR and (2) explore the durability of intervention effects on 24-week changes in body weight.

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

Primary outcomes:
measure: Population-specific accrual
timeFrame: Week 0
measure: Population-specific retention rates
timeFrame: Week 12
measure: GGE app usability
timeFrame: Week 12
measure: GGE intervention acceptability
timeFrame: Week 12
measure: GGE adherence
timeFrame: Weeks 1-4
Secondary outcomes:
measure: Changes in body weight
timeFrame: Weeks 0-12 and Weeks 12-24
measure: Changes in insulin resistance (HOMA-IR)
timeFrame: Weeks 1-12
measure: Changes in glycemic variability
timeFrame: Weeks 1-12
measure: Changes in oxidative stress
timeFrame: Weeks 1-12
measure: Changes in the soluble receptor for advanced glycation end-products (sRAGE)
timeFrame: Weeks 1-12
Other outcomes:
Locations:
Study officials:
affiliation: Georgetown's Lombardi Comprehensive Cancer Center
name: Susan M Schembre
role: PRINCIPAL_INVESTIGATOR
affiliation: Georgetown's Lombardi Comprehensive Cancer Center
name: Nina Kadan-Lottick
role: PRINCIPAL_INVESTIGATOR
References:
citation: Schembre SM, Jospe MR, Giles ED, Sears DD, Liao Y, Basen-Engquist KM, Thomson CA. A Low-Glucose Eating Pattern Improves Biomarkers of Postmenopausal Breast Cancer Risk: An Exploratory Secondary Analysis of a Randomized Feasibility Trial. Nutrients. 2021 Dec 16;13(12):4508. doi: 10.3390/nu13124508.
citation: Schembre SM, Jospe MR, Bedrick EJ, Li L, Brewster AM, Levy E, Dirba DD, Campbell M, Taylor RW, Basen-Engquist KM. Hunger Training as a Self-regulation Strategy in a Comprehensive Weight Loss Program for Breast Cancer Prevention: A Randomized Feasibility Study. Cancer Prev Res (Phila). 2022 Mar 1;15(3):193-201. doi: 10.1158/1940-6207.CAPR-21-0298.