Establishment of Precise Nutrition Management Scheme for Patients With Prediabetes Based on Nutrigenomics
试验速览
- 阶段
- 不适用
- 发起方
- 入组人数
- 60
- 试验地点
- 1
- 主要终点
- HbA1c
研究概览
简要总结
With the aging of population and the change of lifestyle, the prevalence of prediabetes is increasing year by year. Nutritional factors are one of the important environmental factors in the occurrence and development of abnormal glucose metabolism. The medical nutritional treatment of diabetes is recommended as the cornerstone of diabetes treatment by various guidelines. With the development of nutrigenomics, it has been found that genes related to the absorption, metabolism, distribution and excretion of various nutrients are related to diabetes. This study intends to conduct precision nutrition intervention for prediabetic patients based on nutritional genes, and evaluate the effectiveness and safety of these nutritional interventions.
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
- 18 Years 至 70 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •OGTT: 6.1 mmol/L ≤ fasting plasma glucose < 7.0 mmol/L and（or）7.8 mmol/L ≤ 2 hour plasma glucose < 11.1 mmol/L and (or) 5.7% ≤ HbA1c< 6.5%.
- •18 ≤ Age <70.
排除标准
- •Patients who can be diagnosed with diabetes mellitus.
- •Patients applying antidiabetic drugs, glucocorticoids, and other drugs that have an effect on blood glucose.
- •Females during pregnancy or lactation.
- •Patients with gastrointestinal disorders, psychiatric disorders, autoimmune disorders, tumors, etc.
- •Patients with acute cardiovascular and (or) cerebrovascular diseases within 6 months prior to study participation.
- •Patients with hepatic dysfunction (ALT, AST, or total bilirubin ≥ 2 times the upper limit of normal), renal dysfunction (creatinine > the upper limit of normal), and cardiac dysfunction (NYHA class III and IV).
结局指标
主要结局
HbA1c
时间窗: week 0, week 12, week 24
次要结局
- Concentration of 2-hour plasma glucose(week 0, week 24)
- Concentration of fasting plasma glucose(week 0, week 12, week 24)
- Concentration of fasting insulin(week 0, week 12, week 24)
- Concentration of TC, TG, LDL-C, and HDL-C(week 0, week 12, week 24)
- Concentration of creatinine(week 0, week 12, week 24)
- Waist hip ratio(week 0, week 4, week 8, week 12, week 16, week 20, week 24)
- Concentration of ALT, AST, TBIL(week 0, week 12, week 24)
- Concentration of fasting C peptide(week 0, week 12, week 24)
- BMI(week 0, week 4, week 8, week 12, week 16, week 20, week 24)
研究者
Ma Xiao
Director of health examination center department
China-Japan Friendship Hospital