Precision Metabolic Mechanisms of Low Carbohydrate and Ketogenic Diet
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 41
- 试验地点
- 4
- 主要终点
- Weight
研究概览
简要总结
This study will assess the preliminary efficacy of a lifestyle intervention including low-carb/ketogenic diet and exercise, enhanced by self-monitoring through health technologies on weight and diabetes outcomes (Glucose, HbA1c) and diabetic complications (cognitive function, and renal function) in a 6-month randomized clinical trial in 60 overweight/obese adults with or without T2D. Renal function will be assessed via both traditional and novel biomarkers, including novel metabolites and mitochondrial function.
详细描述
Participants in both groups will receive standardized health education sessions including lifestyle management, blood glucose control, blood pressure control, and prevention of diabetic complications from trained providers who are also investigators of this study. The lifestyle intervention from the evidence-based Group Lifestyle Balance (GLB) program (http://www.diabetesprevention.pitt.edu/index.php/for-the-public/for-health-providers/group-lifestyle-balance-curriculum/) and Look AHEAD intervention (https://www.lookaheadtrial.org) will be modified for this study. Goal for weight loss and physical activity will be set for each participant based on recommendations from GLB and Look AHEAD. Lifestyle intervention will be delivered through interactive digital lessons. Smart phone and mobile health devices will be used for each participant to self-monitor diet, physical activity, weight, glucose level, blood pressure, and blood ketone (if randomized to the low-car/ketogenic diet group).
Control group (mHealth+ low-fat diet group):
The low-fat group will be asked to restrict total calorie and total fat consumption according to the Look AHEAD intervention and MyPlate guidelines, with 26-44% carbs, 10-30% protein, and less than 30% fat.
Intervention group (mHealth+ low-carb/ketogenic diet group):
The low-carb/ketogenic diet group, will have total calorie set according to Look AHEAD intervention, and carb consumption restriction will be set based on recommendations from American Diabetic Association, National Kidney Foundation, and other evidence-based resources. Participants in this group will be asked to consume a low-carb/ketogenic diet. Specially, participants will receive a carbohydrate, protein, and fat intake goal based on 1.5 : 1 ratio (1.5 grams of fat to 1 gram of carbohydrate and protein combined). Daily macronutrient and calorie consumption will be individualized for each participant using ideal body weight as inferred from wrist circumference and activity level. Carbohydrate consumption will be less than 10% (20~50 g), protein 10-20% (1.0~1.2g/kg ideal body weight), and fat 70-80% of total daily energy, respectively. Nutritional ketosis will be reached by consuming such diet (0.5 mmol/L).
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Other
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Willing to participate in the study
- •being 18 and over
- •For overweight/obese adults (BMI≥25kg/m2)
- •without self-reported diagnosis of Type 2 Diabetes (T2D) or Chronic Kidney Disease (CKD): Estimated Glomerular Filtration Rate (eGFR)≥90mL/min/1.73m2 and urine albumin to creatinine ratio (ACR)<30mg/g within the past 12 months
- •with Type 2 Diabetes (T2D) but without Chronic Kidney Disease (CKD): Estimated glomerular filtration rate (eGFR)≥90mL/min/1.73m2 and Albumin-to-Creatinine ratio (ACR)<30mg/g within the past 12 months
- •with early stage Chronic Kidney Disease (CKD): 60≤eGFR<90mL/min/1.73m2 or 30mg/g ≤ACR< 1000mg/g within the 12 months
- •can speak and understand English
- •own a smart phone or tablet that has reliable internet/data access
- •agree to comply with all study requirements
排除标准
- •Patients with triglyceride ≥ 500 mg/dL or with Low-Density Lipoprotein Cholesterol≥ 129mg/dL
- •type 1 diabetes (by self-report)
- •severe psychiatric disorders deemed by investigators, which might interfere with study procedures (by self-report)
- •severe chronic conditions (e.g. severe heart disease, renal disease, cognitive impairment, etc.) that would preclude them from participating
- •unwillingness to sign the consent form and be randomized into a study group
- •enrollment in other low carb/keto diet or weight loss programs
- •inability to walk without assistance (by self-report)
- •under SGLT2 inhibitor treatment
- •being pregnant or breast feeding (by self-report)
- •having plans to leave the city or USA for over 2 weeks within 6 months at enrollment
结局指标
主要结局
Weight
时间窗: Baseline to 6 months
Measure of weight change that occurred while assigned to the diet
次要结局
- Blood pressure(Baseline to 6 months)
- Mitochondrial DNA(Baseline to 6 months)
- BMI(Baseline to 6 months)
- Blood lipids(Baseline to 6 months)
- Estimated Glomerular Filtration rate (eGFR)(Baseline to 6 months)
- Albumin-to-Creatinine ratio (ACR)(Baseline to 6 months)
- HbA1c(Baseline to 6 months)
- Metabolites(Baseline to 6 months)