A Prospective Observational Study to Evaluate the Role of the Gut Microbiome in Modulating Response to Semaglutide in Participants With Diabetes and Obesity (Gut2GLP)
Actively Recruiting
The Metabolic and Chronic Disease Research Unit
Research Team
About This Study
This prospective observational study evaluates the role of the gut microbiome in modulating response to semaglutide in participants with diabetes and obesity. The primary objective is to determine whether baseline and longitudinal differences in gut microbial composition are associated with variability in treatment effectiveness and gastrointestinal tolerability among individuals receiving GLP-1 receptor agonist therapy. Participants will be followed over 12 months with study assessments at baseline, 3, 6, and 12 months. Data collection includes stool samples, bloodwork, body measurements, and validated questionnaires assessing diet, physical activity, medication adherence, and gastrointestinal symptoms. Clinical data will be obtained from medical records where available to support evaluation of metabolic outcomes and treatment-related adverse effects.
Who Can Participate?
✓ Inclusion Criteria
- •Participants with any level of kidney function
- •Participants must be ≥ 18 years of age at the time of consent.
- •Diagnosis of diabetes and/or obesity.
- •Prescribed or initiating semaglutide (GLP-1 receptor agonist) as part of routine clinical care.
- •Willing and able to provide stool and blood samples and complete study questionnaires.
- •Able to provide informed consent.
✗ Exclusion Criteria
- •Inability or unwillingness to provide stool samples.
- •Inability to complete study procedures or questionnaires.
- •In the opinion of the investigator, any condition that may impact the ability to safely participate in or complete study procedures.