Testing a Very Low-carbohydrate Diet Version of the Diabetes Prevention Program to Reduce Risk Factors for Type 2 Diabetes: The LEAP (Lifestyle Education About Prediabetes) Study
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 304
- 试验地点
- 2
- 主要终点
- Change in HbA1c
研究概览
简要总结
This research will test whether a standard version or very low-carbohydrate version of the Diabetes Prevention Program better improves outcomes like blood glucose control and body weight for patients with prediabetes.
Participants will have screening (includes blood draw) and baseline testing with a continuous glucose monitor. Once these enrollment steps are completed and the participants will be randomized to one of two groups: standard National Diabetes Prevention Program (NDPP) or a very low-carbohydrate version.
In addition to the diet (12 months) participants will be asked to participate in hour-long weekly group classes over zoom. After four months in the program, classes will occur about every month to help participants maintain the new diet. There will also be check-ins and follow-up visits through out the study.
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
- Single (Outcomes Assessor)
盲法说明
Outcome assessment and data analysis will be masked
入排标准
- 年龄范围
- 21 Years 至 75 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •overweight, defined as BMI >= 25 kg/m2 >= 23 kg/m2 if of Asian descent
- •HbA1c between 5.7% - 6.4% verified at baseline
- •willingness to participate in group-based sessions
- •able to engage in at least light physical activities such as walking
- •willingness to follow a prescribed diet, be randomized, self-weight, track diet, and report physical activity minutes
- •physician approval to participate
排除标准
- •history of type 1 diabetes or type 2 diabetes
- •use of anti-obesity medications or participation in another weight loss program or intervention
- •use of glucose lowering medications other than metformin
- •pregnant or planning to become pregnant during the intervention period
- •breastfeeding
- •use of oral corticosteroids
- •previous bariatric surgery or planning to have bariatric surgery during the study period
- •blood disorders that influence HbA1c, including frequent blood transfusions, phlebotomy, anemia, hemoglobinopathy, polycythemia
- •any condition for which the study team deems participation to be unsafe or inappropriate
- •inability to read, write, or speak English
- •inability to provide informed consent
- •adherence to a vegan or vegetarian diet
- •adherence to a very low-carbohydrate (keto) diet
- •difficulty chewing or swallowing
- •no influence over what foods are purchased, prepared, and/or served
- •above weight limit for DEXA (500 pounds)
- •untreated eating disorder or mental health conditions, such as depression with suicidal ideation, bipolar or schizophrenia with psychosis
- •use of warfarin
- •chronic kidney disease, stage 4 or higher
- •use of loop diuretics: 20mg or higher of furosemide or equivalent (Lasix (furosemide), Bumex (bumetanide), Ederin or Sodium Edecrin (ethacrynic acid), Demadex or Soaanz (torsemide))
- •any concerning values in baseline labs (participants will be referred to Primary Care Physician and will be allowed to return for later enrollment if labs are no longer concerning)
- •Triglycerides 600 Milligrams per deciliter (mg/dL) or higher
- •Thyroid stimulating hormone of any abnormal value
- •Potassium of any abnormal value
结局指标
主要结局
Change in HbA1c
时间窗: 0 to 12 months
HbA1c levels will be measured by standard immunoturbidimetric assay methods and quality control measures at a Clinical Laboratory Improvement Amendments (CLIA) certified lab.
次要结局
- Change in high-density lipoproteins (HDL)(0 to 12 months)
- Change in HbA1c(0 to 4 months)
- Change in Inflammation based on C-reactive protein (CRP)(0 to 12 months)
- Change in percent body weight loss(0-12 months)
- Change in small particle low-density lipoproteins (LDL)(0 to 12 months)
- Change in glycemic variability(0 to 12 months)
- Change in triglycerides(0 to 12 months)
研究者
Laura Saslow
Assistant Professor
University of Michigan