DiabetesNCT07784127
Whole Gut Motility Abnormalities Following GLP-1 Receptor Agonist (GLP-1RA) Initiation
A study testing Gut motility quantification using a capsule after initiating GLP-1RA therapy in people with Diabetes, run by The Cleveland Clinic at 1 site in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Diabetes
- What is being tested?
- Gut motility quantification using a capsule after initiating GLP-1RA therapy
- Type of treatment
- Pill or oral medicine, Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 20 participants
- Where
- 1 siteUnited States
- Study dates
- Dec 2026to Dec 2028
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
United States1 site
Cleveland Clinic
Cleveland, Ohio, 44195
Samita Garg, MD, 216-444-2384, GARGS@ccf.org
Samita Garg, MD
About this study
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.
- Conditions
- Diabetes
- Being tested
- Gut motility quantification using a capsule after initiating GLP-1RA therapy
- Medical subject headings
- Diabetes Mellitus
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Gut motility quantification using a capsule after initiating GLP-1RA therapyProcedure or 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.
| Study group | Role | What they receive |
|---|---|---|
| Participants initiating GLP-1RA therapy | Experimental | Participants starting the GLP-1RA or dual agonist therapy and taking their GLP-1RA or dual agonist therapy for 3 months. Receives: Procedure: Gut motility quantification using a capsule after initiating GLP-1RA therapy |
What is being measured
The primary outcome is the main question the study is designed to answer.
Patient reported outcome for gastroparesis symptoms as assessed by Gastroparesis Cardinal Symptom Index (GCSI) Questionnaire
Measured: At Baseline and 3 Month Follow Up
Patient-Reported Severity and Frequency of Gastrointestinal Symptoms as Assessed by Gastrointestinal Symptom Rating Scale (GSRS) Questionnaire
Measured: 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
Measured: At Baseline and 3 Month Follow Up
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted25 Aug 2026
- Study startDec 2026 (estimated)
- Primary completionAug 2028 (estimated)
- Study completionDec 2028 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for DiabetesStudies of the same condition, open and under way.
- More trials run by The Cleveland ClinicThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Diagnosis
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 20 participants (estimated)
Sponsor and investigators
- Lead sponsor
- The Cleveland Clinic
- Sponsor type
- University, hospital or other
- Collaborators
- Atmo Biosciences Pty Ltd
- Responsible party
- Principal investigator, Samita Garg, The Cleveland Clinic
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07784127
- Sponsor's protocol ID
- 26-115
- Status last verified
- Aug 2026
- First submitted
- 17 Aug 2026
- Last updated
- 25 Aug 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 25 Aug 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Whole Gut Motility Abnormalities Following GLP-1 Receptor Agonist (GLP-1RA) Initiation
- ClinicalTrials.gov ID
- NCT07784127
- Acronym / sponsor ID
- 26-115
- Conditions
- Diabetes
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 20 participants (estimated)
- Lead sponsor
- The Cleveland ClinicUniversity, hospital or other
- Collaborators
- Atmo Biosciences Pty Ltd
- Study start
- Dec 2026 (estimated)
- Primary completion
- Aug 2028 (estimated)
- Study completion
- Dec 2028 (estimated)
- First posted
- 25 Aug 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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
- Primary purpose
- Diagnosis
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Participants initiating GLP-1RA therapy | Experimental | Procedure: Gut motility quantification using a capsule after initiating GLP-1RA therapyParticipants starting the GLP-1RA or dual agonist therapy and taking their GLP-1RA or dual agonist therapy for 3 months. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- 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
Key exclusion criteria (7 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Gut motility quantification using a capsule after initiating GLP-1RA therapyParticipants 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. | Procedure or surgery | Participants initiating GLP-1RA therapy |
Primary outcome
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
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 25 Aug 2026.
- Individual participant dataSharing planned: Undecided
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Gut motility quantification using a capsule after initiating GLP-1RA therapy in people with Diabetes, run by The Cleveland Clinic at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 7 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: opening soon, as of the sponsor's last update on 25 Aug 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Each site lists its own contact: choose the nearest one under Trial locations. AzTrials does not enrol participants or take referrals.
What does the 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). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 25 Aug 2026.