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

Study Overview
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Brief Summary
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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
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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.

Official Title
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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

Conditions
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Diabetes Mellitus, Type 2, Obesity

Intervention / Treatment
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* Dietary Supplement: OPTIFAST dietary supplement


Participation Criteria
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Eligibility Criteria
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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.

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 65 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Interventional 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)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: OPTIFAST Arm<br>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<br>* Participants will use Optifast Nutrition Supplement as previously described<br>|
| No Intervention: Control/Usual Care Arm<br>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. | |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Partial Remission of Diabetes | HbA1c<6.5% without antihyperglycemic medications | 12 months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Improved Insulin Resistance | Reduction of Fasting Insulin | 12 months | 
| Improved Blood Pressure | Reduction in blood pressure measures | 12 months | 
| Weight loss | Reduction in BMI | 12 months | 
| Reduction in Visceral Adiposity | Reduction in waist circumference | 12 months |