Diabetes
Conditions
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.
Interventions
PROCEDUREGut motility quantification using a capsule after initiating GLP-1RA therapy
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.
Sponsors
The Cleveland Clinic
Atmo Biosciences Pty Ltd
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
DIAGNOSTIC
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
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.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| 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 |
Countries
United States
Outcome results
None listed