Type 2 Diabetes Mellitus
Conditions
Interventions
This is a prospective, single-arm study in which volunteers will be randomly selected from Family Health Units (USFs) in the city of Lavras-MG, based on searches in the medical records of patients wit
D06.472.317.680.500.500
Sponsors
Universidade Estadual de Campinas
Universidade Federal de Lavras
Eligibility
Age
18 Years to 60 Years
Inclusion criteria
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
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)
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Evaluate stool samples from volunteers using metagenomics to investigate whether treatment with the drug semaglutide is capable of modifying intestinal bacterial communities | — |
Secondary
| Measure | Time frame |
|---|---|
| Apply metabolomic analysis to the volunteers' blood sample to verify whether treatment with the drug semaglutide determines changes in the metabolic profile;Apply flow cytometry analysis to the volunteers' blood sample to verify whether treatment with the drug semaglutide determines changes in the immune response;Evaluate the 24-hour dietary record of volunteers undergoing semaglutide use to quantify possible changes in food intake;Evaluate the body composition of volunteers through bioimpedance to determine whether treatment with semaglutide for 8 weeks is capable of determining changes in the parameters evaluated by the exam;Apply the Pittsburgh questionnaire to volunteers to verify whether treatment with the drug semaglutide is capable of modifying sleep quality parameters | — |
Countries
Brazil
Contacts
Public ContactMário Saad
Universidade Estadual de Campinas
Outcome results
None listed