Epigenetic and Microbiota Modifications in the Genesis of Adipose Tissue Dysfunction
试验速览
- 阶段
- 早期 1 期
- 状态
- 已完成
- 发起方
- 入组人数
- 22
- 试验地点
- 1
- 主要终点
- Changes in HOMA-IR
研究概览
简要总结
In order to investigate how gut microbiota interventions are able to change gut microbiota population and impact insulin resistance, 30 type2 diabetes volunteers with obesity will be randomized to one of the three treatment groups: 1) probiotics arm, who will take a Lactobacillus fermentum D3 in pills daily; 2) FMT arm, who will take a lyophilized fecal microbiota transplant in pills; and 3) control group, who will take placebo pills. After 3 months, insulin resistance, glucose metabolism parameters, and gut microbiota variation will be assessed.
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 (Participant)
入排标准
- 年龄范围
- 30 Years 至 70 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Type2 diabetes in treatment with metformin
- •30 kg/m2≤IMC≤40 kg/m2
- •30-70 years old
- •HOMA-IR >6
- •Informed consent
排除标准
- •psychopathologic alterations that do not permit the adherence to the trial.
- •Diabetes medication different from metformin.
- •History of cholecystectomy.
- •Use of Probiotics, and/or antibiotics in the last 3 months
研究组 & 干预措施
Probiotics arm
Individuals who receive a probiotics pill daily: Lactobacillus fermentum D3 (PCT/EP 2012058214)
干预措施: Lactobacillus fermentum D3 (Dietary Supplement)
FMT arm
Individuals who receive a FMT in the form of pills with fecal material from a healthy donor.
干预措施: Fecal microbiota transplant (FMT) (Biological)
Control arm
Individuals who receive a probiotics pill daily of placebo (milk powder)
干预措施: Placebo (Drug)
结局指标
主要结局
Changes in HOMA-IR
时间窗: Baseline, 12 weeks
Homeostasis Model Assessment of fasting Insulin Resistance (HOMA-IR: glucose (mmol/l( x insulin (pmol/l)/22.5)
次要结局
- Changes in glucose metabolism(Baseline, 12 weeks)
- Changes in gut microbiota(Baseline, 12 weeks)