Glucose-Guided Eating Pilot

Prediabetes Clinical Trial

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Official title:

Glucose-Guided Eating to Reduce Chronic Disease Risk: a Pilot Study

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT05998460
• Other study ID #: STUDY00006573
• Status: Not yet recruiting
• Phase: N/A
• Start date: January 2, 2024
• Est. completion date: August 2025

Study information

• Verified date: June 2023
• Source: Georgetown University
• Contact: Princess M Georges
• Phone: 2026872117
• Email: pg763[@]georgetown.edu
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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).

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.

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 100
• Est. completion date: August 2025
• Est. primary completion date: August 2025
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Adolescent and Young Adult (AYA) Cancer Survivors
• Postmenopausal
• Prediabetes
• Prediabetic State

Intervention

Behavioral:
• Glucose-Guided Eating with CGM
The GGE intervention consist of up to four weeks of training to learn to eat when glucose levels are at or below their usual fasting level. Specifically, participants following GGE will self-monitor their glucose levels with an unblinded CGM while using a mobile app (GGE app) that will provide feedback on whether or not to eat. At desired mealtimes participants will enter their current glucose level, rate their perceived hunger, and label the type of hunger they are experiencing (physical, emotional, sensory and practical). Participants following GGE will be instructed by the app to eat when two conditions are met: (a) the desire to eat arises and (b) their glucose levels are at or below a personalized threshold. During the training period, participants are meant to associate feelings of perceived hunger with fasting glucose levels (i.e., physical hunger). After the training period, participants continue to follow GGE without CGM or use of the app.

Other:
• CGM only
Comparator participants will use unblinded CGM for up to 4 weeks without the use of the GGE app or any other dietary recommendations.

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Georgetown University

References & Publications (2)

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. — View 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. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Population-specific accrual	Population-specific accrual will reflect rates of study enrollment and will be defined as number of participants consented to the number of individuals who are determined to be eligible.	Week 0
Primary	Population-specific retention rates	Population-specific retention rates will reflect the proportion of enrolled participants who complete the study.	Week 12
Primary	GGE app usability	The app usability will be assessed using the 10-item System Usability Scale. SUS scores have a range of 0 to 100 with 100 representing greatest usability.	Week 12
Primary	GGE intervention acceptability	GGE intervention acceptability will be assessed with a study specific survey (collected from participants randomized to the GGE intervention only).	Week 12
Primary	GGE adherence	GGE adherence will be quantified as percent of reported eating events occurring at or below personalized glucose thresholds/personalized average fasting glucose levels that is collected using the GGE app (collected from participants randomized to the GGE intervention only-during use of the GGE app only).	Weeks 1-4
Secondary	Changes in body weight	Changes in body weight will be measured using calibrated digital scales (measured in kilograms).	Weeks 0-12 and Weeks 12-24
Secondary	Changes in insulin resistance (HOMA-IR)	Changes in insulin resistance will be measured as homeostatic model assessment for insulin resistance (HOMA-IR). It will be computed from fasting insulin and fasting glucose (fasting insulin (microU/L) x fasting glucose (nmol/L)/22.5).	Weeks 1-12
Secondary	Changes in glycemic variability	Changes in glycemic variability will be assessed from CGM data using the freely accessible EasyGV software available from the University of Oxford (https://www.phc.ox.ac.uk/research/resources/easygv).	Weeks 1-12
Secondary	Changes in oxidative stress	Changes in oxidative stress will be measured as 8-isoprostane from spot urine.	Weeks 1-12
Secondary	Changes in the soluble receptor for advanced glycation end-products (sRAGE)	Changes the sRAGE was measured in serum by ELISA.	Weeks 1-12