Whole Gut Motility Abnormalities Following GLP-1 Receptor Agonist (GLP-1RA) Initiation
Trial Snapshot
- Phase
- Not Applicable
- Status
- Not yet recruiting
- Sponsor
- The Cleveland Clinic
- Enrollment
- 20
- Locations
- 1
- Primary Endpoint
- Patient reported outcome for gastroparesis symptoms as assessed by Gastroparesis Cardinal Symptom Index (GCSI) Questionnaire
Study Overview
Brief 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.
Study Design
- Study Type
- Interventional
- Allocation
- Na
- Intervention Model
- Single Group
- Primary Purpose
- Diagnostic
- Masking
- None
Eligibility Criteria
- Ages
- 18 Years to — (Adult, Older Adult)
- Sex
- All
- Accepts Healthy Volunteers
- No
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.
Outcomes
Primary Outcomes
Patient reported outcome for gastroparesis symptoms as assessed by Gastroparesis Cardinal Symptom Index (GCSI) Questionnaire
Time Frame: At Baseline and 3 Month Follow Up
Patient-Reported Severity and Frequency of Gastrointestinal Symptoms as Assessed by Gastrointestinal Symptom Rating Scale (GSRS) Questionnaire
Time Frame: 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
Time Frame: At Baseline and 3 Month Follow Up
Secondary Outcomes
No secondary outcomes reported
Investigators
Samita Garg
Associate Professor of Medicine
The Cleveland Clinic