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

Part of paid clinical trials in Cleveland, Ohio.

Sponsor
The Cleveland Clinic
Study ID
NCT07784127
Status
Not Yet Recruiting

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Conditions

  • Diabetes

Eligibility Criteria

Sex
ALL
Age
18 Years - N/A
Healthy Volunteers
Not accepted

Interventions

  • 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.

Study Details

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.

Key Dates

First listed
Aug 25, 2026
Start date
Dec 31, 2026
Status verified
Aug 2026
Primary completion
Aug 31, 2028
Completion
Dec 31, 2028

Study Design

Enrollment
20 participants (estimated)
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
DIAGNOSTIC

Arms

  • Experimental: Participants 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.

Primary Outcome Measure

Patient reported outcome for gastroparesis symptoms as assessed by Gastroparesis Cardinal Symptom Index (GCSI) Questionnaire [ Time Frame: At Baseline and 3 Month Follow Up ]

Locations (1)

FacilityCityStateZIPSite coordinators
Cleveland ClinicClevelandOhio44195
Samita Garg, MD
[email protected]
216-444-2384
Samita Garg, MD (PRINCIPAL_INVESTIGATOR)

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By research site
Cleveland Clinic· Cleveland, OH

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