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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT04764279
Recruitment Status : Unknown
Verified February 2021 by Dr. Megen Brunskill, Marathon Family Health Team.
Recruitment status was:  Not yet recruiting
First Posted : February 21, 2021
Last Update Posted : February 21, 2021
Sponsor:
Information provided by (Responsible Party):
Dr. Megen Brunskill, Marathon Family Health Team

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.

Condition or disease Intervention/treatment Phase
Diabetes Mellitus, Type 2 Obesity Dietary Supplement: OPTIFAST dietary supplement Not Applicable

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.

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 30 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Intervention 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)
Primary Purpose: Treatment
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
Estimated Study Start Date : June 2021
Estimated Primary Completion Date : June 2022
Estimated Study Completion Date : December 2022

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Experimental: OPTIFAST Arm
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.
Dietary Supplement: OPTIFAST dietary supplement
Participants will use Optifast Nutrition Supplement as previously described

No Intervention: Control/Usual Care Arm
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.



Primary Outcome Measures :
  1. Partial Remission of Diabetes [ Time Frame: 12 months ]
    HbA1c<6.5% without antihyperglycemic medications


Secondary Outcome Measures :
  1. Improved Insulin Resistance [ Time Frame: 12 months ]
    Reduction of Fasting Insulin

  2. Improved Blood Pressure [ Time Frame: 12 months ]
    Reduction in blood pressure measures

  3. Weight loss [ Time Frame: 12 months ]
    Reduction in BMI

  4. Reduction in Visceral Adiposity [ Time Frame: 12 months ]
    Reduction in waist circumference



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Ages Eligible for Study:   18 Years to 65 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04764279


Contacts
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Contact: Megen T Brunskill, MD 807-229-3243 mbrunskill@mfht.org
Contact: Eliseo Orrantia, MD 807-229-3243 eorrantia@mfht.org

Sponsors and Collaborators
Marathon Family Health Team
Investigators
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Principal Investigator: Megen T Brunskill, MD Marathon Family Health Team
Additional Information:
Publications:

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Responsible Party: Dr. Megen Brunskill, Principal Investigator, Marathon Family Health Team
ClinicalTrials.gov Identifier: NCT04764279    
Other Study ID Numbers: C-20-3
First Posted: February 21, 2021    Key Record Dates
Last Update Posted: February 21, 2021
Last Verified: February 2021
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
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Diabetes Mellitus
Obesity
Diabetes Mellitus, Type 2
Glucose Metabolism Disorders
Metabolic Diseases
Endocrine System Diseases
Overnutrition
Nutrition Disorders
Overweight
Body Weight