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

Not Applicable

• Conditions: Diabetes Mellitus, Type 2; Obesity
• Interventions: Dietary Supplement: OPTIFAST dietary supplement

• Registration Number: NCT04764279
• Lead Sponsor: 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.

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.

Study Timeline

• Status Verified: 2021-02
• Study First Submitted: 2021-02-17
• Study First Submitted QC: 2021-02-17
• Last Update Submitted: 2021-02-17
• Study First Posted: 2021-02-21
• Last Update Posted: 2021-02-21
• Study Start: 2021-06
• Primary Completion: 2022-06
• Study Completion: 2022-12

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 30

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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
OPTIFAST Arm	OPTIFAST dietary supplement	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.

Primary Outcome Measures

Name	Time	Method
Partial Remission of Diabetes	12 months	HbA1c\<6.5% without antihyperglycemic medications

Secondary Outcome Measures

Name	Time	Method
Improved Blood Pressure	12 months	Reduction in blood pressure measures
Improved Insulin Resistance	12 months	Reduction of Fasting Insulin
Weight loss	12 months	Reduction in BMI
Reduction in Visceral Adiposity	12 months	Reduction in waist circumference