Clinical trial NCT04764279: 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
Overall status: UNKNOWN
Phase: NA
Conditions: Diabetes Mellitus, Type 2
Obesity
Lead sponsor: Marathon Family Health Team
Sponsor class: OTHER
First posted: 2021-02-21
Enrollment: 30
Sex: ALL
Minimum age (years): 18
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
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.
Primary purpose: TREATMENT

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.

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.

Primary outcomes:
measure: Partial Remission of Diabetes
timeFrame: 12 months
Secondary outcomes:
measure: Improved Insulin Resistance
timeFrame: 12 months
measure: Improved Blood Pressure
timeFrame: 12 months
measure: Weight loss
timeFrame: 12 months
measure: Reduction in Visceral Adiposity
timeFrame: 12 months
Other outcomes:
Locations:
Study officials:
affiliation: Marathon Family Health Team
name: Megen T Brunskill, MD
role: PRINCIPAL_INVESTIGATOR
References:
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