NCT05237128已完成不适用
Comparing Two Dietary Approaches for Type 2 Diabetes: The LEGEND (Lifestyle Education About Nutrition for Diabetes) Study
适应症
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 182
- 试验地点
- 4
- 主要终点
- Change in HbA1c
研究概览
简要总结
This study is being completed to compare two dietary approaches for participants with type 2 diabetes. This research will test whether a very low-carbohydrate or a plate-method diet better improves outcomes for blood glucose control and body composition for patients with type 2 diabetes that follow one of these approaches for 12 months.
Participants that meet screening and eligibility will be randomized to one of the two diets. In addition to the diet, study specific visits and assessments will be performed at various timepoints.
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 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •diagnosis of type 2 diabetes, with current HbA1c > 6.5% and < 12% (self-reported and then measured at screening)
- •ability to speak English (this is a group-based intervention)
- •ability to engage in light physical activity
- •willingness to be randomized to either type of diet
排除标准
- •unable to provide informed consent
- •substance abuse, mental health, cognitive, or medical condition that would, in the opinion of the investigators, make it difficult for the individual to take part in the intervention, may alter key outcomes, or may require important diet modifications and includes conditions such as hypercalcemia or thyroid dysfunction
- •pregnant or planning to become pregnant in the next 12 months, or currently breastfeeding (pregnancy and breastfeeding require modifications to the intervention's dietary approaches)
- •current use of weight loss medications (this is likely to alter weight outcomes and may alter other measures)
- •history of weight loss (bariatric) surgery or plans for bariatric surgery in the next year
- •currently enrolled in a weight loss program or have unalterable plans to enroll in one of these programs in the next year
- •vegan or vegetarian
- •unwilling or unable to participate in study measurements and group classes
- •current use of systemic steroids (self-reported in screening survey; oral or IV systemic steroids excluded. Injected steroids may be permitted depending on frequency and timing of injections with regard to lab assessments (minimum of 2 weeks between injection and blood tests))
- •weight above 400 pounds (weight limit for dual-energy X-ray absorptiometry (DEXA) scans)
- •history of multiple or recent (within the last four years) kidney stones
- •currently following a very low-carbohydrate diet
- •unwilling to stop an SGLT2 inhibitor medication if the participant were to be randomized to the very low-carbohydrate diet
结局指标
主要结局
Change in HbA1c
时间窗: 0 to 12 months
HbA1c 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 Inflammation based on high sensitivity C-reactive protein (hsCRP)(0 to 12 months)
- Change in high-density lipoproteins (HDL)(0 to 12 months)
- Change in percent lean body mass on DEXA(0 to 12 months)
- Change in HbA1c(0 to 4 months)
- Change in bone mineral density in total hip(0 to 12 months)
- Change in small particle low-density lipoproteins (LDL)(0 to 12 months)
- Change in triglycerides(0 to 12 months)
- Change in percent body fat on DEXA(0 to 12 months)
- Change in bone mineral density in lumbar spine(0 to 12 months)
- Reduction in diabetes medications using medication effect score (MES)(0 to 12 months)
- Change in percent body weight loss(0 to 12 months)
- Change in serum procollagen type I N propeptide (s-PINP)(0 to 12 months)
- Change in serum c-terminal telopeptide of type 1 collagen (s-CTX)(0 to 12 months)
研究者
Laura Saslow
Assistant Professor
University of Michigan
研究点 (4)
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