Whole Gut Motility Abnormalities Following GLP-1 Receptor Agonist (GLP-1RA) Initiation

NCT07784127 — Not applicable, Not yet recruiting, 20 participants, The Cleveland Clinic

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Registry	NCT07784127
Status	Not yet recruiting
Phase	Not applicable
Study type	Interventional; na, single group, masking: none, diagnostic
Enrollment	20 (Estimated)
Sponsor	The Cleveland Clinic (Other); collaborators: Atmo Biosciences Pty Ltd
Conditions	Diabetes
Interventions	Gut motility quantification using a capsule after initiating GLP-1RA therapy (Procedure)
Dates	start 2026-12-01 (estimated), primary completion 2028-08-01 (estimated), completion 2028-12-01 (estimated), first posted 2026-08-25, last updated 2026-08-25
Locations	1 site in United States

-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.

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+Arms and interventions

Arm	Type	Interventions	Description
Participants initiating GLP-1RA therapy	Experimental	Procedure: Gut motility quantification using a capsule after initiating GLP-1RA therapy	Participants starting the GLP-1RA or dual agonist therapy and taking their GLP-1RA or dual agonist therapy for 3 months.

Gut motility quantification using a capsule after initiating GLP-1RA therapy (Procedure): 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.

+Outcome measures

Primary outcomes

Patient reported outcome for gastroparesis symptoms as assessed by Gastroparesis Cardinal Symptom Index (GCSI) Questionnaire [At Baseline and 3 Month Follow Up]
Patient-Reported Severity and Frequency of Gastrointestinal Symptoms as Assessed by Gastrointestinal Symptom Rating Scale (GSRS) Questionnaire [At Baseline and 3 Month Follow Up]
Patient-Reported frequency, duration, and diagnostic criteria for conditions affecting the gastrointestinal tract for colonic motility and function as Assessed by Rome IV Diagnostic Questionnaire [At Baseline and 3 Month Follow Up]

+Eligibility

Sex: All, ages: 18 Years to any

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.

+Locations (1)

Facility	City	Country	Status
Cleveland Clinic	Cleveland, Ohio	United States