Fecal Microbiota Transplantation Intervention on Microbiota Composition and Insulin Sensitivity in Diabetes
试验速览
- 阶段
- 不适用
- 状态
- 进行中（未招募）
- 发起方
- 入组人数
- 16
- 试验地点
- 1
- 主要终点
- Insulin sensitivity
研究概览
简要总结
The purpose of the trial is to investigate the effect of fecal microbiota transplantation versus placebo on glycemic metabolism and gut microbiota composition in people with type 2 diabetes.
详细描述
People with type 2 diabetes have been shown to exhibit an altered composition of the gut microbiota, including a reduced abundance of butyrate-producing bacteria. Although the underlying mechanisms are not fully elucidated, alterations in gut microbiota composition may be important in the pathogenesis of type 2 diabetes and in metabolic regulation. Fecal microbiota transplantation (FMT) from lean donors has been shown to transiently improve insulin sensitivity and increase the abundance of butyrate-producing bacteria in individuals with metabolic syndrome.
A double-blinded, randomized, placebo-controlled trial will be conducted to investigate the effects of FMT on glycaemic metabolism and gut microbiota composition in individuals with type 2 diabetes. A total of 16 participants will be randomly assigned to one of two groups, receiving either FMT or placebo.
Glycaemic metabolism will be assessed at baseline and again at week 7 post-intervention using three complementary measures: the Homeostatic Model Assessment of Insulin Resistance (HOMA-IR), an oral glucose tolerance test (OGTT) for the Matsuda index, and continuous glucose monitoring (CGM). In addition, stool samples will be collected before and after the intervention to evaluate changes in gut microbiota composition following FMT, for example using 16S rRNA gene sequencing.
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
- Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
入排标准
- 年龄范围
- 18 Years 至 67 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Has type 2 diabetes
排除标准
- •Treatment with insulin or sulfonylurea drugs.
- •Treatment with antibiotics, probiotics/lactic acids cultures, or proton pump inhibitors within the last three months.
- •Regular exercise and/or more than 150 minutes of moderate intensity exercise or 75 minutes of high intensity exercise per week, within the last 6 months.
- •Diagnosed with unstable angina, recent (within the last 8 weeks) myocardial infarction, any disease in the coronal arteries, decompensated heart failure (NYHA II-IV), severe valvular disease, lung disease
- •Hypertension which is not currently under medical control (systolic pressure >200 mmHg and/or diastolic pressure >130 mmHg)
- •Bariatric surgery within the previous year or a plan to undergo bariatric surgery during the study period
- •Self-reported drug or alcohol abuse
- •Patients preparing for or currently experiencing pregnancy during the study period
- •Disease of the liver and/or gallbladder, including parenchymal liver disease, liver cirrhosis, pancreatitis, autoimmune liver disease
- •All diseases of the gastrointestinal tract, which can lead to or increase the risk of defects in the mucosal membrane. This includes chronic diarrhea, inflammatory bowel disease, malabsorption, malnutrition, recent infection with clostridium difficile, primary sclerosing cholangitis, radiation induced enteritis, chemotherapy induced diarrhea, hematological diseases
- •Reactive hypoglycemia
- •Anemia and other diseases of the bone marrow
- •Kidney diseases, including moderate albuminuria and other disturbances in the electrolytes balance
- •Food allergies, allergies towards catheters (i.e. Venflon) and other instruments used in the study.
- •Other condition deeming individuals inappropriate for recruitment according to the investigators or sponsor
研究组 & 干预措施
Fecal Microbiota Transplantation
The participants will receive two rounds of FMT with two weeks between each treatment.
干预措施: Fecal Microbial Transplantation (Other)
Placebo
Placebo capsules visually identical to FMT capsules
干预措施: Placebo (Other)
结局指标
主要结局
Insulin sensitivity
时间窗: At baseline and at week 7
Insulin sensitivity assessed by the Matsuda index, calculated from plasma glucose (in mmol/L) and serum insulin(in pmol/L) concentrations measured repeatedly during a standardized oral glucose tolerance test at baseline and after 7 weeks.
次要结局
- Time-in-range(At baseline and at week 7)
- Hemoglobin A1c(At baseline and at week 7)
- Glucose management indicator(At baseline and at week 7)
- Body mass index(At baseline and at week 7)
- Waist circumference(At baseline and at week 7)
- Microbiome analysis(At baseline and at week 7)
研究者
Henrik Holm Thomsen
Consultant Endocrinologist
Central Jutland Regional Hospital