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NCT07784127
Whole Gut Motility Abnormalities Following GLP-1 Receptor Agonist (GLP-1RA) Initiation
Conditions: Diabetes
Sex: All
Ages: 18 Years – N/A
Healthy volunteers: No
Phase: NA
Enrollment: 20
Sponsor: The Cleveland Clinic
Location: Cleveland Clinic Cleveland Ohio
Summary
Participants will undergo evaluation with the Atmo capsule at two time points: at baseline before starting the GLP-1RA or dual agonist therapy and after the subject has been taking their GLP-1RA or dual agonist therapy for 3 months. The total expected time for patient participation is up to 4 months from the time they start their GLP-1RA or dual agonist therapy.
Eligibility Criteria
Inclusion Criteria:
* Adult patients (18 years or older)
* Initiating GLP-1RA or GLP-1RA/GIP (dual agonist) therapy, or off GLP-1RA or GLP1-RA/GIP therapy for greater than 3 months for the treatment of type 2 diabetes with or without obesity (BMI \> 30 kg/m2) at the time of the baseline visit
* Stable glucose control (HbA1c ≤ 9%) within 6 months of the baseline visit
* Normal TSH within 6 months of baseline visit
Exclusion Criteria:
* Current use of opiates, marijuana, anticholinergics, or pro-motility medications. Can be included if there is no utilization for at least 1 month.
* Use of antibiotics within the past 2 weeks
* History of gastric or bowel surgery
* Known or suspected history or active intestinal obstruction or stricture
* Pregnancy
* Patients for whom English is not their primary language will be excluded.
* Cognitively impaired persons or other vulnerable populations who are unable to provide informed consent will be excluded.
Source: ClinicalTrials.gov (NCT07784127). StuddyBuddy aggregates publicly available trial information.