Whole Gut Motility Abnormalities Follow… | Clinical Trial

Key information

Conditions

Diabetes Diabetes Mellitus Endocrine System Diseases Glucose Metabolism Disorders Metabolic Diseases Nutritional and Metabolic Diseases

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Cleveland Clinic

Cleveland, Ohio, 44195, United States

Location contact

Samita Garg, MD

CONTACT

[email protected]

216-444-2384

Samita Garg, MD

PRINCIPAL_INVESTIGATOR

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

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.

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

Sponsors and collaborators

Lead sponsor

The Cleveland Clinic

Other

Collaborators

Atmo Biosciences Pty Ltd

Registry information

Important dates

Study start: 2026
Primary completion: 2028
Study completion: 2028
First posted: Aug 25, 2026
Registry last updated: Aug 25, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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