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A Rural OPTIFAST Intervention for Partial Remission of Type 2 Diabetes in Adults With Obesity

Primary Purpose

Diabetes Mellitus, Type 2, Obesity

Status
Unknown status
Phase
Not Applicable
Locations
Study Type
Interventional
Intervention
OPTIFAST dietary supplement
Sponsored by
Marathon Family Health Team
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Diabetes Mellitus, Type 2

Eligibility Criteria

18 Years - 65 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

  • Study participants will be patients of the MFHT, aged 18 to 65, BMI between 27 and 45 kg/m 2 , and newly diagnosed with DMII within the past 6 years.

Exclusion Criteria:

  • The exclusion criteria will be anti-hyperglycemic medications, slow onset of type 1 diabetes (DMI) or maturity onset diabetes of the young (MODY), renal dysfunction (serum creatinine>150 μmol/l), history of myocardial infarction, untreated thyroid disease, consumption of 4 alcohol units/day by men and 3 units/day by women, chronic steroid consumption, unstable psychiatric conditions, and atypical antipsychotic medication.

Sites / Locations

    Arms of the Study

    Arm 1

    Arm 2

    Arm Type

    Experimental

    No Intervention

    Arm Label

    OPTIFAST Arm

    Control/Usual Care Arm

    Arm Description

    Participants in the intervention group will be given OPTIFAST® meal replacement shakes, 4 per day to achieve 900kcal/day, for the first 12 weeks of the study. The second phase will consist of partial meal replacement and food reintroduction over a 4 week period. When the intervention group begins to reintroduce foods, all study participants will be provided a workbook, created for the study, to explain optimal lifestyle changes for DMII management. The third phase will be a 8-month follow-up of participants on continued healthy lifestyle as described in the workbook.

    Usual Care : A gift card will be offered to participants in the control group to stabilize the incentive of the intervention. Participants in the control group will receive usual diabetes care based on the current Canadian Diabetes Association guidelines by their family physician. Participants in the control group will receive the same workbook as the intervention group at 16 weeks into the study.

    Outcomes

    Primary Outcome Measures

    Partial Remission of Diabetes
    HbA1c<6.5% without antihyperglycemic medications

    Secondary Outcome Measures

    Improved Insulin Resistance
    Reduction of Fasting Insulin
    Improved Blood Pressure
    Reduction in blood pressure measures
    Weight loss
    Reduction in BMI
    Reduction in Visceral Adiposity
    Reduction in waist circumference

    Full Information

    First Posted
    February 17, 2021
    Last Updated
    February 17, 2021
    Sponsor
    Marathon Family Health Team
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    1. Study Identification

    Unique Protocol Identification Number
    NCT04764279
    Brief Title
    A Rural OPTIFAST Intervention for Partial Remission of Type 2 Diabetes in Adults With Obesity
    Official Title
    Rural-specific OPTIFAST Intervention - A Randomized Study for Partial Remission of Type 2 Diabetes in Patients With Obesity Between the Age of 18 and 65
    Study Type
    Interventional

    2. Study Status

    Record Verification Date
    February 2021
    Overall Recruitment Status
    Unknown status
    Study Start Date
    June 2021 (Anticipated)
    Primary Completion Date
    June 2022 (Anticipated)
    Study Completion Date
    December 2022 (Anticipated)

    3. Sponsor/Collaborators

    Responsible Party, by Official Title
    Principal Investigator
    Name of the Sponsor
    Marathon Family Health Team

    4. Oversight

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

    5. Study Description

    Brief Summary
    As rural Canada is a resource poor health service environment, we propose to test whether an OPTIFAST dietary replacement intervention, without the service intensive behavioural component, can cause partial remission of DMII in patients with obesity and DMII.
    Detailed Description
    The objective of this study is to see if a rural-specific OPTIFAST intervention, of dietary replacement only, can cause a partial remission of DMII patients with obesity between the age of 18 and 65 diagnosed with DMII within the last 6 years. The goal is to inform the current diabetes routine care by standardizing a rural protocol on the effectiveness of rural-specific OPTIFAST intervention for people with DMII who want to attain partial remission of DMII.

    6. Conditions and Keywords

    Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
    Diabetes Mellitus, Type 2, Obesity

    7. Study Design

    Primary Purpose
    Treatment
    Study Phase
    Not Applicable
    Interventional Study Model
    Parallel Assignment
    Model Description
    A two arm, open-label randomized study will be conducted with a total of 30 patients being randomly assigned (1:1) to either of the two study arms: VLCD ( OPTIFAST®) intervention or best-practice care (control). The sample size was determined assuming a 46% partial remission rate of DMII in the VLCD group at year 1 and 4% in the usual care group and power of 80%. These rates are based on the findings of the DiRECT study.
    Masking
    None (Open Label)
    Allocation
    Randomized
    Enrollment
    30 (Anticipated)

    8. Arms, Groups, and Interventions

    Arm Title
    OPTIFAST Arm
    Arm Type
    Experimental
    Arm Description
    Participants in the intervention group will be given OPTIFAST® meal replacement shakes, 4 per day to achieve 900kcal/day, for the first 12 weeks of the study. The second phase will consist of partial meal replacement and food reintroduction over a 4 week period. When the intervention group begins to reintroduce foods, all study participants will be provided a workbook, created for the study, to explain optimal lifestyle changes for DMII management. The third phase will be a 8-month follow-up of participants on continued healthy lifestyle as described in the workbook.
    Arm Title
    Control/Usual Care Arm
    Arm Type
    No Intervention
    Arm Description
    Usual Care : A gift card will be offered to participants in the control group to stabilize the incentive of the intervention. Participants in the control group will receive usual diabetes care based on the current Canadian Diabetes Association guidelines by their family physician. Participants in the control group will receive the same workbook as the intervention group at 16 weeks into the study.
    Intervention Type
    Dietary Supplement
    Intervention Name(s)
    OPTIFAST dietary supplement
    Intervention Description
    Participants will use Optifast Nutrition Supplement as previously described
    Primary Outcome Measure Information:
    Title
    Partial Remission of Diabetes
    Description
    HbA1c<6.5% without antihyperglycemic medications
    Time Frame
    12 months
    Secondary Outcome Measure Information:
    Title
    Improved Insulin Resistance
    Description
    Reduction of Fasting Insulin
    Time Frame
    12 months
    Title
    Improved Blood Pressure
    Description
    Reduction in blood pressure measures
    Time Frame
    12 months
    Title
    Weight loss
    Description
    Reduction in BMI
    Time Frame
    12 months
    Title
    Reduction in Visceral Adiposity
    Description
    Reduction in waist circumference
    Time Frame
    12 months

    10. Eligibility

    Sex
    All
    Minimum Age & Unit of Time
    18 Years
    Maximum Age & Unit of Time
    65 Years
    Accepts Healthy Volunteers
    No
    Eligibility Criteria
    Inclusion Criteria: Study participants will be patients of the MFHT, aged 18 to 65, BMI between 27 and 45 kg/m 2 , and newly diagnosed with DMII within the past 6 years. Exclusion Criteria: The exclusion criteria will be anti-hyperglycemic medications, slow onset of type 1 diabetes (DMI) or maturity onset diabetes of the young (MODY), renal dysfunction (serum creatinine>150 μmol/l), history of myocardial infarction, untreated thyroid disease, consumption of 4 alcohol units/day by men and 3 units/day by women, chronic steroid consumption, unstable psychiatric conditions, and atypical antipsychotic medication.
    Central Contact Person:
    First Name & Middle Initial & Last Name or Official Title & Degree
    Megen T Brunskill, MD
    Phone
    807-229-3243
    Email
    mbrunskill@mfht.org
    First Name & Middle Initial & Last Name or Official Title & Degree
    Eliseo Orrantia, MD
    Phone
    807-229-3243
    Email
    eorrantia@mfht.org
    Overall Study Officials:
    First Name & Middle Initial & Last Name & Degree
    Megen T Brunskill, MD
    Organizational Affiliation
    Marathon Family Health Team
    Official's Role
    Principal Investigator

    12. IPD Sharing Statement

    Plan to Share IPD
    No
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    Citation
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    Links:
    URL
    https://www.ourcommons.ca/Content/Committee/421/HESA/Reports/RP10365941/hesarp23/hesarp23-e.pdf
    Description
    Canadian Diabetes Strategy
    URL
    https://search-proquest-com.proxy1.lib.uwo.ca/docview/1885883419?accountid=15115&pq-origsite=summon
    Description
    Reversibility of Type 2 Diabetes
    URL
    http://www.canada.ca/en/public-health/services/publications/diseases-conditions/diabetes-canada-highlights-chronic-disease-surveillance-system.html
    Description
    Diabetes in Canada

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    A Rural OPTIFAST Intervention for Partial Remission of Type 2 Diabetes in Adults With Obesity

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