Evaluation of the pattern of gut bacteria in patients with type 2 Diabetes Mellitus using the drug Semaglutide

Not Applicable

• Conditions: E00-E90; Type 2 Diabetes Mellitus; Gastrointestinal Microbiome; Peptídeo 1 Semelhante ao Glucagon

• Registration Number: RBR-5xhygvd
• Lead Sponsor: niversidade Estadual de Campinas

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Completion: 2024-07-31
• Study Start: 2024-08-09
• Last Update Posted: 19 August 2024

Recruitment & Eligibility

• Status: Recruitment completed
• Sex: Not specified
• Target Recruitment: Not specified

Inclusion Criteria

Both sexes; aged between 18-60 years; individuals with type 2 Diabetes Mellitus or Pre-Diabetes; with glycated hemoglobin between 5,7% and 10%; body mass index (BMI) of 25-39.99 Kg/m²; not using medication for Diabetes or using only oral antidiabetics (metformin and/or sulfonylurea); and creatinine clearance above 30ml/min/1,73m²

Exclusion Criteria

Age outside the proposed range; pregnant women; smoking; patients with Type 1 Diabetes Mellitus; individuals with suspected or confirmed retinopathy; patients with chronic intestinal pathology; patients previously submitted to bariatric surgery or any surgery that results in any one of resection/injury of the nervous plexus/deviation of intestinal transit; patients with severe chronic kidney disease (creatinine clearance = 30ml/min/1.73m²); patients with moderate-intense gastroesophageal reflux disease; patients with a history of recurrent pancreatitis (because of an unclear cause, or an identified and still present cause); individuals who are using insulin; individuals who used any type of antibiotic in the last 3 months; individuals who make continuous use of probiotic drugs or proton pump inhibitors (omeprazole, pantoprazole, lansoprazole, esomeprazole, etc.); individuals who have used GLP-1 analogue drugs in the last 3 months; individuals who have a significant psychiatric disorder that may be related to the incorrect use of the medication and interfere with the results (schizophrenia, bipolar disorder, alcoholism, use of illicit substances, etc)

Study & Design

• Study Type: Intervention
• Study Design: Not specified