Lifestyle Intervention Trial to Treat Type 2 Diabetes in the Republic of the Marshall Islands
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 138
- 主要终点
- Fasting glucose
研究概览
简要总结
The Republic of the Marshall Islands has the highest prevalence of type 2 diabetes (T2D) in the world. This clinical trial tested whether a community-based, intensive, plant-rich lifestyle intervention with exercise is more effective for treating and managing T2D in the Republic of the Marshall Islands than the standard of diabetes care. The intensive lifestyle intervention consisted of a plant-rich diet and moderate exercise. It centered around a 12-week program of counseling and instruction on healthy eating, exercise, and stress management, as well as hands-on cooking classes and prepared meals. Cardiometabolic outcomes were assessed throughout the intervention and at 24 weeks. The present study is the first randomized clinical trial ever conducted in the Republic of the Marshall Islands and the first lifestyle intervention trial conducted in Micronesia.
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 75 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Resident of the Republic of Marshall Islands
- •Aged 18 - 75 years
- •HbA1c ≥ 8.0% or diagnosed with T2D and taking diabetes medication
- •Medical clearance to participate from Diabetes Wellness Center (DWC) physicians.
排除标准
- •Recent (≤3 months) change in a diabetes-related medication dosage
- •A physical or medical condition that would impede participation in the lifestyle intervention (e.g., wheel-chair bound, unstable angina)
- •Evidence of significant coronary heart disease
- •Previous participation in an intensive lifestyle intervention
结局指标
主要结局
Fasting glucose
时间窗: Change from Week 0 to Week 24
mg/dl
HOMA-IR
时间窗: Change from Week 0 to Week 24
Insulin resistance as measured by HOMA-IR
HbA1c
时间窗: Change from Week 0 to Week 24
Percent
Fasting insulin
时间窗: Change from Week 0 to Week 24
mU/l
Usage of diabetes medications
时间窗: Change from Week 0 to Week 24
Number as measured by the medication effect score
次要结局
- High-sensitivity C-reactive protein(Change from Week 0 to Week 24)
- Body weight(Change from Week 0 to Week 24)
- Cholesterol (total, HDL, LDL) and triglycerides(Change from Week 0 to Week 24)
- Blood pressure(Change from Week 0 to Week 24)
- Heart rate(Change from Week 0 to Week 24)
- Waist circumference(Change from Week 0 to Week 24)
- Body mass index (BMI)(Change from Week 0 to Week 24)
研究者
Courtney M Peterson
Assistant Professor
University of Alabama at Birmingham