Changes in Intestinal Barrier Function and Gut Microbiome After Duodenal Mucosal Resurfacing
试验速览
- 阶段
- 不适用
- 发起方
- 入组人数
- 100
- 主要终点
- Microbiome Analysis
研究概览
简要总结
The aim of this study is to demonstrate the effects of duodenal mucosal resurfacing (DMR) on intestinal barrier function and gut microbiota when treating uncontrolled type 2 diabetes. Subjects who underwent DMR and those who did not were enrolled, and potential differences were identified by analyzing urine and fecal samples through microbiotic analysis and High Performance Liquid Chromatography (HPLC), combined with changes in clinical data.
详细描述
This study aims to enroll 100 patients diagnosed with type 2 diabetes who have suboptimal control with one or more oral antidiabetic drugs. Of these, 50 will receive DMR treatment at the Metabolic Weight Loss Center of the China-Japan Friendship Hospital and will be followed up, while the other 50, who have not received DMR treatment, will be matched by age and gender for comparison. Each patient or their legal guardian will sign an informed consent form to participate in the study. Researchers will be granted access to the patients' medical records and will collect their medical history and treatment data. Researchers will also collect urine and fecal samples for microbiome analysis，metagenomics-based studies and HPLC, analyzing the changes in intestinal barrier function and gut microbiota before and after DMR treatment, and between DMR-treated and non-DMR-treated patients.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Basic Science
- 盲法
- None
入排标准
- 年龄范围
- 25 Years 至 65 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •- 1.25-65 years of age. 2.Diagnosed with type 2 diabetes. 3.Glycated Hemoglobin (HbA1c) of 7.5 - 10.0% (59-86 mmol/mol). 4.Body Mass Index (BMI) ≥ 24 and ≤ 40 kg/m
- •5.Currently taking one or more oral glucose lowering medications, with no changes in dose or medication in the previous 12 Weeks prior to study entry.
- •6.Able to comply with study requirements and understand and sign the informed consent.
排除标准
- •Clinical diagnosis of type 1 diabetes.
- •Current use of Glucagon-like peptide-1 (GLP-1) analogues.
- •Hypoglycemia unawareness or a history of severe hypoglycemia.
- •Clinical diagnosis of autoimmune disease.
- •Previous gastrointestinal surgery that could affect the ability to treat the duodenum.
- •Use of anticoagulation therapy (such as warfarin) which cannot be discontinued for 7 days before and 14 days after the procedure.
- •Clinical diagnosis of anemia.
- •Not potential candidates for surgery or general anesthesia.
- •Participating in another ongoing clinical trial of an investigational drug or device.
- •Any other mental or physical condition which, in the opinion of the Investigator, makes the subject a poor candidate for clinical trial participation.
结局指标
主要结局
Microbiome Analysis
时间窗: one week and one month post-treatment
Characterization of of gut microbiome using next generation sequencing technology
High Performance Liquid Chromatography
时间窗: one week and one month post-treatment
Intestinal barrier function using HPLC technology
次要结局
未报告次要终点
研究者
Wang Siqi
medical doctor
China-Japan Friendship Hospital