Gut microbiota changes and type 2 diabetes mellitus resolution in mild obesity after metabolic surgery versus advanced medical therapy

St. John's Hospital (Portugal)0 个研究点目标入组 20 人开始时间: 2014年5月1日最近更新: 2021年6月7日

适应症

试验速览

•1. Age between 20-65 years old
•2. BMI between 30-35Kg/m2
•3. Previous diagnosis of type 2 diabetes, according to the American Diabetes Association (ADA) definition, under medical therapy
•4. Duration of diabetes more than 3 months
•5. Overnight-fasting C-peptide more than 0.7 ng/ml
•6. Negative anti-GAD autoantibody
•7. Candidate for general anesthesia
•8. The ability and willingness to participate in the study, including understanding the requirements of each arm of the study (written informed consent)

•1. Specific contraindication to obesity surgery
•2. Diabetes secondary to a specific disease (maturity-onset diabetes of the young, latent autoimmune diabetes in adult and pancreatitis)
•3. Received any antibiotic, probiotic, or prebiotic agents in the month before randomization
•4. Pregnancy
•5. Debilitating disease
•6. Psychological conditions which may hamper patient?s cooperation
•7. Any condition which, in the judgement of the investigator, may make the participation in the study risky or bias the results

发起方

St. John's Hospital (Portugal)