Study Summary
 

This study aims to understand how the gut microbiome may influence how people with diabetes and obesity respond to the GLP-1 receptor agonist (GLP-1RA) medication semaglutide (commonly known by the brand name Ozempic).

GLP-1RA medications are used to treat diabetes, obesity, and metabolic conditions, but drug response can vary widely. Some individuals lose weight and tolerate the medication well, while others experience digestive symptoms such as nausea, diarrhea, or constipation.

The microbes that live in the digestive system (the gut microbiome) may affect how well semaglutide works and what side effects people experience. This study will examine participants’ gut microbiome over time to better understand how they relate to treatment success and drug tolerability.

Study Activities
 

If you take part, you will complete study procedures at four time points: at enrollment, 3 months, 6 months, and 12 months. Most information will be collected from your medical chart, and the study team may ask you for information that is not available there.

During the study, we will collect:
 

• Information from your medical chart, including age, sex, gender, race/ethnicity, medical history, medications, duration of diabetes, and available bloodwork or urine results.
   

• Fecal samples, collected at home using the Bunny Wipe Fecal Sample Collector, a quick and easy collection tool.
   

• Body measurements, including weight, height, blood pressure, heart rate, waist circumference, and hip circumference. These may be done during your regular clinic visits or at a brief study visit.
   

• Blood samples for tests not routinely ordered in your clinical care. These will be taken at enrolment, 3 months, 6 months, and 12 months. We will try to combine them with your routine bloodwork when possible.
   

• Four questionnaires, completed at enrolment, 3 months, 6 months, and 12 months:

  • Digestion-Associated Quality of Life Questionnaire

  • Exercise as a Vital Sign

  • The Mini-EAT dietary questionnaire

  • GLP-1RA Adherence and Persistence
     

Questionnaires may be completed in person, by mail, or by email.

Your blood / fecal samples and questionnaire responses will be stored securely, and your personal information will not appear in any study reports.



Time Commitment
 

The study involves participation over 12 months, with four study time points. Body measurements take about 15 minutes. Stool samples and questionnaires can be completed from home.

The study team will do as much data collection as possible from your medical records to reduce your time commitment. If extra visits are needed, they will be scheduled at your convenience.

You may take breaks during study visits or stop participation at any time. You may withdraw your information at any point before it is anonymized and included in the final results.

End Goals
 

We hope to learn how the gut microbiome affects semaglutide tolerance and effectiveness in adults with diabetes and obesity. By identifying microbial patterns associated with better outcomes or fewer side effects, we aim to develop personalized treatment strategies for those with metabolic disease.