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
试验速览
- 阶段
- 不适用
- 发起方
- 入组人数
- 30
- 主要终点
- Partial Remission of Diabetes
研究概览
简要总结
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.
详细描述
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.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 65 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •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.
排除标准
- •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.
研究组 & 干预措施
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.
干预措施: OPTIFAST dietary supplement (Dietary Supplement)
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.
结局指标
主要结局
Partial Remission of Diabetes
时间窗: 12 months
HbA1c\<6.5% without antihyperglycemic medications
次要结局
- Improved Blood Pressure(12 months)
- Improved Insulin Resistance(12 months)
- Weight loss(12 months)
- Reduction in Visceral Adiposity(12 months)
研究者
Dr. Megen Brunskill
Principal Investigator
Marathon Family Health Team