Effects of Dietary Fiber on Glucose Control in Subjects With Type 2 Diabetes Mellitus
试验速览
- 阶段
- 4 期
- 状态
- 已完成
- 入组人数
- 14
- 主要终点
- Quantitative insulin sensitivity check index (QUICKI)
研究概览
简要总结
The purpose of this study is to determine the effect of a commercial dietary fiber supplement on patients with type 2 diabetes mellitus, in the way of glucose control, insulin action in the body, and the gut microbiota (bacteria) abundance.
详细描述
Fiber supplements such as psyllium are known to be beneficial to glycemic control in patients with type 2 diabetes mellitus (T2DM). Gut microbiota has a role in regulating host energy metabolism and systemic inflammation by several pathways such as short-chain fatty acid production, fasting-induced adipose factor expression, endocannabinoid system, and gut epithelial permeability. As dietary components can influence the composition of the microbiota, we hypothesized that fiber supplements could modify gut microbiota and consequently affect glycemic control and inflammatory condition in patients with T2DM.
The primary outcome was to assess the effect of fiber on glucose control (by comparing fasting glucose and glycoalbumin), insulin secretion and sensitivity. Secondary outcomes were the changes abundance of microbiota, incretins, and lipopolysaccharide (LPS).
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 50 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- 未提供
排除标准
- 未提供
研究组 & 干预措施
Agio arm
It is a pilot study based on the proof-of-concept that dietary fiber helps glucose control in patients with type 2 diabetes. As a single-arm study, 'Agiocur Pregranules' (dietary fiber) is administered for 28 days and stopped for next 28 days, in patients with type 2 diabetes.
干预措施: Agiocur Pregranules (Drug)
结局指标
主要结局
Quantitative insulin sensitivity check index (QUICKI)
时间窗: the 4th week of study
By comparing the level of 4th week, compared to baseline. QUICKI is derived from fasting blood glucose and insulin level, reflecting insulin sensitivity.
Fasting glucose
时间窗: the 4th week of study
By comparing the level of 4th week, compared to baseline
Glycoalbumin
时间窗: the 4th week of study
By comparing the level of 4th week, compared to baseline
Insulinogenic index
时间窗: the 4th week of study
By comparing the level of 4th week, compared to baseline
次要结局
- Incretins (GIP)(the 4th week of study)
- Incretins (GLP-1)(the 4th week of study)
- Incretins (GLP-2)(the 4th week of study)
- Lipopolysaccharide (LPS)(the 4th week of study)
- Microbiota composition change(the 4th week of study)
研究者
MOON-KYU LEE
Professor, Division of Endocrinology and Metabolism, Department of Internal Medicine
Samsung Medical Center