The Effects of Dietary Supplementation on Hepatic Insulin Action and Glucose Tolerance in Pre-diabetes
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- Mayo Clinic
- 入组人数
- 48
- 试验地点
- 1
- 主要终点
- Changes in liver fat content after 12 weeks of intervention
研究概览
简要总结
Assessment of glucose metabolism and liver fat after 12 week dietary intervention in pre diabetes subjects. Subjects will be randomized to either high fat (olive oil supplemented),high carb/high fiber (beans supplemented) and high carb/low fiber diets. Glucose metabolism will be assessed by labeled oral glucose tolerance test and liver fat by magnetic resonance spectroscopy pre randomization and at 8 and 12 week after starting dietary intervention.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Basic Science
- 盲法
- Single (Investigator)
入排标准
- 年龄范围
- 30 Years 至 80 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Impaired fasting glucose(100-125 mg/dl)
- •HbA1c 5.7-6.4 %
- •BMI 26-40 kg/sq.m
排除标准
- •MRS contraindication
- •Pregnant women
- •Liver disease
研究组 & 干预措施
high fat ( MUFA) diet
intervention using high fat diet.
干预措施: Dietary intervention (Dietary Supplement)
high carb/high fiber
diet using high carb-high fiber with dry beans
干预措施: Dietary intervention (Dietary Supplement)
high carb/low fat
Habitual diet
干预措施: Dietary intervention (Dietary Supplement)
结局指标
主要结局
Changes in liver fat content after 12 weeks of intervention
时间窗: 12 weeks
次要结局
- Change in glucose metabolism after 12 weeks of intervention(12 weeks)