Weight Management for the Remission of Type 2 Diabetes Using a Proprietary Meal Replacement System- Diabetes Remission Study (DRS)
试验速览
- 阶段
- 不适用
- 状态
- 终止
- 入组人数
- 3
- 试验地点
- 2
- 主要终点
- Efficacy of plant-based meal replacement system on A1-C levels
研究概览
简要总结
A three month meal replacement dietary system which combines meal replacements and self-prepared meals which hypothetically will result in Diabetes remission in >30% of intervention subjects
To assess the efficacy of which patients with Type 2 Diabetes (non insulin dependent) can be brought into a optimal A1C remission state without the use of medications by achieving clinically significant weight loss (>20-30 pounds) using a proprietary meal replacement system associated with a 3-month intensive lifestyle program.
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
- 25 Years 至 65 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Men and Women
- •Ages 25-65
- •Have been diagnosed with non-insulin dependent diabetes for less than five years
- •Are taking at least one oral agents for diabetes
- •English speaking
排除标准
- •Individuals currently being treated for cancer
- •Had a myocardial infarction in the previous 3 months
- •Have uncontrolled persistent hypertension - diastolic >90 systolic >160
- •Individuals with established eating disorder diagnoses
- •Individuals who have recent weight loss attempt in the last 3 months with > 5-pound loss
- •Use of anti-obesity medications in the last three months
- •Individuals who have had bariatric surgery
- •Individuals taking medications that are known to cause weight gain including but not limited to insulin, steroids, haloperidol clozapine, risperidone, olanzapine, amitriptyline imipramine, paroxetine, and lithium
- •Individuals who are pregnant or planning to become pregnant in the next 6 months
结局指标
主要结局
Efficacy of plant-based meal replacement system on A1-C levels
时间窗: Change between baseline and six month visit.
Blood draw to measure the effect of the diet on the A1-C level. Normal A1C is at or below 5.7%. Prediabetes levels range between 5.8%-6.4%. Diabetes is at or above 6.5%.
次要结局
- Efficacy of plant-based meal replacement system on insulin levels(Change between baseline and six month visit.)
研究者
Warren Peters, MD, MPH
Director, Center for Health Promotion
Loma Linda University