Gastrointestinal Microbiome Obesity
Conditions
Interventions
The study intervention will be carried out through the administration of Semaglutide or the combination of Semaglutide with Metformin XR. During the same period, dietary/nutritional intervention will
s own control (pre- and post-intervention comparison).Group A:Medication administered: Semaglutide (GLP-1 receptor agonist).Dose: Up to 2.4 mg per week.Route of administration: Subcutaneous.Injection
Sponsors
Faculdade de Ciências Médicas da Universidade Estadual de Campinas - UNICAMP
Faculdade de Ciências Médicas da Universidade Estadual de Campinas - UNICAMP
Eligibility
Age
20 Years to 60 Years
Inclusion criteria
Inclusion criteria: Adults aged 20 to 60 years; Of both sexes (female and male); With a Body Mass Index (BMI) between 29.0 and 44.0 kg/m²; Preferentially members of the UNICAMP community (where the study will be conducted); All participants must voluntarily sign the Informed Consent Form (ICF) before starting participation in the study, as well as the ICFs for different stages of the study with specific details regarding the procedures
Exclusion criteria
Exclusion criteria: Individuals with type 1 and type 2 diabetes;Individuals with obesity secondary to the use of medications and/or associated diseases (Cushing's syndrome, acromegaly, etc.);Individuals who, within 90 days prior to the start of the study, used GLP-1 receptor agonists, antibiotics, probiotics, or prebiotics; Individuals who have previously undergone surgical treatment for obesity;Individuals who are planning any treatment or intervention that may interfere with weight assessment (intragastric balloon);Individuals allergic to GLP-1 receptor agonists or any other excipient of semaglutide or Metformin XR;Individuals who, in the last 90 days, participated in any study related to obesity, diabetes, and microbiota and who used any medication, probiotic, prebiotic, or antibiotic;Individuals with untreated thyroid dysfunction;Individuals who have had major cardiovascular and/or cerebrovascular events in the last 180 days and/or heart failure;Individuals with severe gastrointestinal disease or inflammatory bowel disease;Individuals with moderate to severe depression or severe mental illness such as schizophrenia and bipolar disorder;Individuals with acute or chronic pancreatitis;Individuals with chronic kidney disease with a glomerular filtration rate (GFR) less than 30 mL/min/1.73m²;Individuals with liver cirrhosis; Individuals with active rheumatologic diseases;Individuals diagnosed with a malignant tumor in the last 5 years; Individuals with a diagnosed eating disorder (bulimia or binge eating)
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| A percentage variation in body weight is expected after 24 weeks of treatment between the groups (Semaglutide + Metformin XR vs. Semaglutide alone) | — |
Secondary
| Measure | Time frame |
|---|---|
| A change in waist circumference and waist-to-hip ratio is expected after 24 weeks;A decrease in fasting glucose levels and glycated hemoglobin (HbA1c) is expected after 24 weeks ;Changes in body composition assessed by dual-energy X-ray absorptiometry (DEXA) (total fat, visceral fat, lean mass) are expected at 24 weeks;Change in gut microbiome alpha and beta diversity from baseline to 24 weeks between groups;Changes in parameters obtained by positron emission tomography combined with computed tomography (PET-CT) related to adipose tissue metabolic activity are expected | — |
Countries
BR
Contacts
Public ContactMario Saad
Universidade Estadual de Campinas
Outcome results
None listed