Novel Intestinal Microbiota-based Product for Preventing Type 2 Diabetes Mellitus
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 26
- 试验地点
- 1
- 主要终点
- Insulin sensitivity
研究概览
简要总结
The study aims to assess the effects of a microbiota-based product containing Intestinimonas in adults with pre-diabetes. The purpose is to determine the safety and efficacy of the microbiota-based product on insulin sensitivity in a target group of prediabetic individuals. In particular, the objective is to evaluate whether Intestinimonas is able to improve the insulin sensitivity, the response to the oral glucose tolerance test (OGTT) and whether it is able to modulate the microbiota composition in the study subjects.
详细描述
The study aims to assess the effects of a microbiota-based product containing Intestinimonas in adults with pre-diabetes.
Intestinimonas is an aerobic microorganism which produces butyrate and interacts with the local microbiota in small and large intestine.
In preclinical studies, it was demonstrated that the insulin sensitivity can be enhanced by Intestinimonas and similar microbiota.
The purpose is to determine the safety and efficacy of the microbiota-based product on insulin sensitivity in a target group of prediabetic individuals.
The study participants will be subjects who are overweight and are at risk of developing Type 2 diabetes.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Factorial
- 主要目的
- Treatment
- 盲法
- Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
入排标准
- 年龄范围
- 18 Years 至 65 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •increased BMI > 25,
- •Fasting Plasma Glucose (FPG) 100-125 mg/dl or glucose > 140 after OGTT, or HbA1c 5.7% - 6.4%
排除标准
- •Type 2 diabetes
结局指标
主要结局
Insulin sensitivity
时间窗: 12 weeks
as measured by Homeostatic Model Assessment (HOMA) - index
次要结局
- Level of 2-hour blood glucose Area Under the Curve (AUC)(12 weeks)
- Concentration of Fasting glucose(12 weeks)