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Glucose-Guided Eating Pilot (GET CHARGED)

Primary Purpose

Postmenopausal, Prediabetes, Adolescent and Young Adult (AYA) Cancer Survivors

Status
Not yet recruiting
Phase
Not Applicable
Locations
Study Type
Interventional
Intervention
Glucose-Guided Eating with CGM
CGM only
Sponsored by
Georgetown University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional prevention trial for Postmenopausal

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria: 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 Criteria: 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

Sites / Locations

    Arms of the Study

    Arm 1

    Arm 2

    Arm Type

    Experimental

    Active Comparator

    Arm Label

    GGE with CGM

    CGM only

    Arm Description

    Participants randomized to the Glucose-Guided Intervention will be trained to align their mealtimes with a personalized glucose threshold monitored using continuous glucose monitoring (CGM) and the GGE study app.

    Participants randomized to the control arm will only wear a CGM.

    Outcomes

    Primary Outcome Measures

    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.
    Population-specific retention rates
    Population-specific retention rates will reflect the proportion of enrolled participants who complete the study.
    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.
    GGE intervention acceptability
    GGE intervention acceptability will be assessed with a study specific survey (collected from participants randomized to the GGE intervention only).
    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).

    Secondary Outcome Measures

    Changes in body weight
    Changes in body weight will be measured using calibrated digital scales (measured in kilograms).
    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).
    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).
    Changes in oxidative stress
    Changes in oxidative stress will be measured as 8-isoprostane from spot urine.
    Changes in the soluble receptor for advanced glycation end-products (sRAGE)
    Changes the sRAGE was measured in serum by ELISA.

    Full Information

    First Posted
    July 21, 2023
    Last Updated
    September 11, 2023
    Sponsor
    Georgetown University
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    1. Study Identification

    Unique Protocol Identification Number
    NCT05998460
    Brief Title
    Glucose-Guided Eating Pilot
    Acronym
    GET CHARGED
    Official Title
    Glucose-Guided Eating to Reduce Chronic Disease Risk: a Pilot Study
    Study Type
    Interventional

    2. Study Status

    Record Verification Date
    June 2023
    Overall Recruitment Status
    Not yet recruiting
    Study Start Date
    November 2023 (Anticipated)
    Primary Completion Date
    August 2025 (Anticipated)
    Study Completion Date
    August 2025 (Anticipated)

    3. Sponsor/Collaborators

    Responsible Party, by Official Title
    Sponsor
    Name of the Sponsor
    Georgetown University

    4. Oversight

    Studies a U.S. FDA-regulated Drug Product
    No
    Studies a U.S. FDA-regulated Device Product
    No
    Data Monitoring Committee
    Yes

    5. Study Description

    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.

    6. Conditions and Keywords

    Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
    Postmenopausal, Prediabetes, Adolescent and Young Adult (AYA) Cancer Survivors

    7. Study Design

    Primary Purpose
    Prevention
    Study Phase
    Not Applicable
    Interventional Study Model
    Parallel Assignment
    Masking
    None (Open Label)
    Allocation
    Randomized
    Enrollment
    100 (Anticipated)

    8. Arms, Groups, and Interventions

    Arm Title
    GGE with CGM
    Arm Type
    Experimental
    Arm Description
    Participants randomized to the Glucose-Guided Intervention will be trained to align their mealtimes with a personalized glucose threshold monitored using continuous glucose monitoring (CGM) and the GGE study app.
    Arm Title
    CGM only
    Arm Type
    Active Comparator
    Arm Description
    Participants randomized to the control arm will only wear a CGM.
    Intervention Type
    Behavioral
    Intervention Name(s)
    Glucose-Guided Eating with CGM
    Intervention Description
    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.
    Intervention Type
    Other
    Intervention Name(s)
    CGM only
    Intervention Description
    Comparator participants will use unblinded CGM for up to 4 weeks without the use of the GGE app or any other dietary recommendations.
    Primary Outcome Measure Information:
    Title
    Population-specific accrual
    Description
    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.
    Time Frame
    Week 0
    Title
    Population-specific retention rates
    Description
    Population-specific retention rates will reflect the proportion of enrolled participants who complete the study.
    Time Frame
    Week 12
    Title
    GGE app usability
    Description
    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.
    Time Frame
    Week 12
    Title
    GGE intervention acceptability
    Description
    GGE intervention acceptability will be assessed with a study specific survey (collected from participants randomized to the GGE intervention only).
    Time Frame
    Week 12
    Title
    GGE adherence
    Description
    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).
    Time Frame
    Weeks 1-4
    Secondary Outcome Measure Information:
    Title
    Changes in body weight
    Description
    Changes in body weight will be measured using calibrated digital scales (measured in kilograms).
    Time Frame
    Weeks 0-12 and Weeks 12-24
    Title
    Changes in insulin resistance (HOMA-IR)
    Description
    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).
    Time Frame
    Weeks 1-12
    Title
    Changes in glycemic variability
    Description
    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).
    Time Frame
    Weeks 1-12
    Title
    Changes in oxidative stress
    Description
    Changes in oxidative stress will be measured as 8-isoprostane from spot urine.
    Time Frame
    Weeks 1-12
    Title
    Changes in the soluble receptor for advanced glycation end-products (sRAGE)
    Description
    Changes the sRAGE was measured in serum by ELISA.
    Time Frame
    Weeks 1-12

    10. Eligibility

    Sex
    All
    Minimum Age & Unit of Time
    18 Years
    Accepts Healthy Volunteers
    No
    Eligibility Criteria
    Inclusion Criteria: 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 Criteria: 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
    Central Contact Person:
    First Name & Middle Initial & Last Name or Official Title & Degree
    Princess M Georges
    Phone
    2026872117
    Email
    pg763@georgetown.edu
    First Name & Middle Initial & Last Name or Official Title & Degree
    Megan Roy
    Email
    mr1839@georgetown.edu
    Overall Study Officials:
    First Name & Middle Initial & Last Name & Degree
    Susan M Schembre
    Organizational Affiliation
    Georgetown's Lombardi Comprehensive Cancer Center
    Official's Role
    Principal Investigator
    First Name & Middle Initial & Last Name & Degree
    Nina Kadan-Lottick
    Organizational Affiliation
    Georgetown's Lombardi Comprehensive Cancer Center
    Official's Role
    Principal Investigator

    12. IPD Sharing Statement

    Plan to Share IPD
    Yes
    IPD Sharing Plan Description
    The investigators intend to publish the protocol in a manuscript and share the IPD through an appropriate free access data repository.
    IPD Sharing Time Frame
    Within 1 year of study completion.
    IPD Sharing Access Criteria
    Shared IPD will be available via freely accessible data registry.
    Citations:
    PubMed Identifier
    34960058
    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.
    Results Reference
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    PubMed Identifier
    34893531
    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.
    Results Reference
    background

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