Health Trials

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

ConditionDiabetes
Trial statusNot yet recruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age18+
SponsorThe Cleveland Clinic

About this trial

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

This trial does not accept healthy volunteers

Qualifiers

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

Disqualifiers

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

Trial design

Design model

Single group

Treatments tested in this trial

  • Gut motility quantification using a capsule after initiating GLP-1RA therapy

    Procedure/Surgery

    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.

Treatment groups

20 Participants
are divided into 1 treatment group
Group A: Participants initiating GLP-1RA therapyExperimental treatment 1 intervention

Trial outcomes

Primary outcomes

1

Patient reported outcome for gastroparesis symptoms as assessed by Gastroparesis Cardinal Symptom Index (GCSI) Questionnaire

Time frame
At Baseline and 3 Month Follow Up
2

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
3

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

Other outcomes

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

The Cleveland Clinic

Lead sponsor

Atmo Biosciences Pty Ltd

Collaborator

Source ClinicalTrials.gov

This trial is not recruiting at the moment. You can still explore other options: