Diabetes Mellitus, Type 2, Obesity
Conditions
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.
Interventions
DIETARY_SUPPLEMENTOPTIFAST dietary supplement
Participants will use Optifast Nutrition Supplement as previously described
Sponsors
Marathon Family Health Team
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
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.
Eligibility
Sex/Gender
ALL
Age
18 Years to 65 Years
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Partial Remission of Diabetes | 12 months | HbA1c\<6.5% without antihyperglycemic medications |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Improved Insulin Resistance | 12 months | Reduction of Fasting Insulin |
| Improved Blood Pressure | 12 months | Reduction in blood pressure measures |
| Weight loss | 12 months | Reduction in BMI |
| Reduction in Visceral Adiposity | 12 months | Reduction in waist circumference |
Contacts
Primary ContactMegen T Brunskill, MD
Backup ContactEliseo Orrantia, MD
Outcome results
None listed