What this trial means for you
This study is opening soon at 1 US site. It's studying see the official record for diabetes.
What participants typically get: study medication (or placebo, if the trial uses one) and study-related medical care at no cost, plus close monitoring. Compensation for time and travel varies by study, ask the site. Note that in many trials you can't choose your treatment group, and some participants receive a placebo.
The study, in the sponsor's words
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.
Can you join? The exact criteria
Below is the verbatim eligibility text from the registry. Bring it to your doctor; it's written for clinicians, and your own clinician is the right person to interpret it with you.
Full eligibility criteria (for you and your doctor)
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.
Study sites by state
Ohio
- Cleveland Clinic, Cleveland
View the official record on ClinicalTrials.gov →
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