Gut microbiota changes and type 2 diabetes resolution in mild obesity after metabolic surgery

Not Applicable

Completed

• Conditions: Type 2 diabetes; Nutritional, Metabolic, Endocrine; Non-insulin-dependent diabetes mellitus

• Registration Number: ISRCTN53984585
• Lead Sponsor: St. John's Hospital (Portugal)

Brief Summary

2021 results in https://pubmed.ncbi.nlm.nih.gov/34020709/ (added 24/05/2021)

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2014-05-01
• Study Completion: 2015-08-31
• Last Update Posted: 7 June 2021

Recruitment & Eligibility

• Status: Completed
• Sex: All
• Target Recruitment: 20

Inclusion Criteria

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)

Exclusion Criteria

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

Study & Design

• Study Type: Interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Assess gut microbiota changes in mild obese (BMI 30-35 Kg/m2) diabetic patients after metabolic surgery and compare the gut microbiota with mild obese (BMI 30-35 Kg/m2) diabetic patients who underwent only advanced medical therapy

Secondary Outcome Measures

Name	Time	Method
<br> 1. Determine the rate of biochemical remission of diabetes after metabolic surgery<br> 2. Assess changes in metabolic, hormonal and inflammatory parameters after metabolic surgery versus advanced medical therapy<br> 3. Study influence of patient characteristics in gut microbiota changes, as well as in metabolic, hormonal and inflammatory parameters, after metabolic surgery versus advanced medical therapy<br> 4. Study associations between type 2 diabetes remission/improvement (metabolic, hormonal and inflammatory changes) and gut microbiota composition/adaptation after metabolic surgery versus advanced medical therapy<br>