Contrasting Ketogenic and Mediterranean Diets in Individuals With Type 2 Diabetes and Prediabetes: The Keto-Med Trial
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 61
- 试验地点
- 2
- 主要终点
- Hemoglobin A1c (HbA1c)
研究概览
简要总结
The objective of this study is to compare two metabolically distinct diets, WFKD vs Med-Plus, in order to examine the potential benefits, and unintended consequences, of going beyond a focus on maximally avoiding added sugars and refined grains, to also avoiding legumes, fruits, and whole grains.
详细描述
The proposed randomized clinical trial will investigate differential population-specific effects of two low-carbohydrate (low-carb) diet patterns, addressing a gap in the evidence base in this area that will lead to 1) improved treatment strategies for common adverse clinical conditions, 2) improved health for these individuals, and 3) long-term decreases in health care costs. This impactful research will advance the field of personalized and precision medicine.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Crossover
- 主要目的
- Prevention
- 盲法
- Double (Investigator, Outcomes Assessor)
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Diagnosed with type 2 diabetes mellitus, OR prediabetes (defined as HbA1c </= 5.7% OR Fasting Glucose of >100 mg/dL)
- •Identify exclusion criteria.
- •Weight < 110 lb
- •BMI > 40
- •LDL-C >190 mg/dL
- •Blood pressure: SBP > 160 mmHg OR DBP: > 90 mmHg
排除标准
- •Weight < 110 lb
- •LDL-C >190 mg/dL
- •Systolic blood pressure (SBP) > 160 mmHg OR Diastolic blood pressure (DBP) > 90 mmHg
- •Diagnosed with type 1 diabetes or history of ketoacidosis
- •Uncontrolled and untreated diabetes (by discretion of study physician)
- •Active cardiovascular disease (in past year with myocardial infarction, coronary stent or bypass surgery)
- •Kidney disease (eGFR less than 50 mL/min per 1.73 m2)
- •Liver disease (liver transaminase higher than 3 times the normal range for the laboratory)
- •Symptomatic gallstones
- •History of bariatric surgery
- •Taking any of the following medications in past 3 months: SGLT-2 inhibitors, GLP-1 receptor agonist, Insulin, Amylin analog, Alpha-glucosidase inhibitor, Dopamine agonist, Bile acid sequestrant.
- •Taking any medications for weight loss
- •History of active cancer in the past 3 years except for squamous or basal cell carcinomas of the skin that have been medically managed by local excision
- •Unstable dietary history as defined by major changes in diet during the previous month, where the subject has eliminated or significantly increased a major food group in the diet.
- •Recent history of chronic excessive alcohol consumption defined as more than five 1.5-ounce servings of 80 proof distilled spirits, five 12-ounce servings of beer or five 5-ounce servings of wine per day; or > 14 drinks/week.
- •Women: Pregnant currently or planning to become pregnant during the course of the study, and/or breastfeeding
- •Regular/frequent use of smoking or chewing tobacco, e-cigarettes, cigars or other nicotine-containing products
- •Regular use of prescription opiate pain medication
结局指标
主要结局
Hemoglobin A1c (HbA1c)
时间窗: Baseline and 12 weeks
Change from baseline in HbA1c at 12 weeks of each phase
次要结局
- Microbiota composition(Baseline and 12 weeks)
- Microbiota function(Baseline and 12 weeks)
- LDL Cholesterol(Baseline and12 weeks)
- Triglycerides(Baseline and 12 weeks)
- HDL Cholesterol(Baseline and 12 weeks)
- Fasting insulin(Baseline and 12 weeks)
- Blood pressure(Baseline and 12 weeks)
研究者
Christopher Gardner
Professor of Medicine
Stanford University