NCT05414409 The Gut Microbiome in Type 1 Diabetes and Mechanism of Metformin Action
| NCT ID | NCT05414409 |
| Status | Recruiting |
| Phase | Phase 2 |
| Sponsor | Heba M. Ismail |
| Condition | Type 1 Diabetes |
| Study Type | INTERVENTIONAL |
| Enrollment | 114 participants |
| Start Date | 2022-09-30 |
| Primary Completion | 2026-11-02 |
Eligibility & Interventions
Eligibility Fast-Check
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What to Expect as a Participant
You will actively receive the study intervention — which may be a drug, biologic, device, or procedure.
In Phase 2, researchers evaluate early signs of effectiveness. You may be randomized to receive the active treatment or a comparator. Monitoring continues closely.
This trial targets 114 participants in total. It began in 2022-09-30 with a primary completion date of 2026-11-02.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
Brief Summary
Ovwerweight and obesity prevalence in persons with T1D has increased, which further complicates management and risk for complications. The proposed study is relevant to public health because it helps us understand the role of the gut microbiome in disease pathophysiology in T1D youth with overweight and obesity as well as potential mechanisms to modify disease.
Eligibility Criteria
Inclusion Criteria: 1. Overweight/obese youth 11-18 years of age with T1D at time of enrollment. 2. Lean youth 11-18 years of age with T1D at time of enrollment. Exclusion Criteria: 1. Known monogenic forms of diabetes or Type 2 diabetes (confirmed clinically and by genetic/antibody testing). 2. History of ongoing infection or antibiotic treatment within the past month; 3. History of immune-compromise, recurrent infections, steroid intake (inhaled or oral forms) or other immunosuppressant use in the past 6 months. 4. History of chronic gastrointestinal disease and active within the past 6 months, possible or confirmed celiac disease. 5. Participation in any research intervention trials within the past 3 months. 6. History of treatment or use of metformin, a type 2 diabetes medication.
Contact & Investigator
Frequently Asked Questions
Who can join the NCT05414409 clinical trial?
This trial is open to participants of all sexes, aged 11 Years or older, up to 18 Years, studying Type 1 Diabetes. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
What phase is the NCT05414409 trial and what does that mean for participants?
Phase 2 trials evaluate whether the treatment shows signs of effectiveness while continuing to monitor safety. More participants are enrolled than in Phase 1 to help refine the treatment protocol.
Is NCT05414409 currently recruiting?
Yes, NCT05414409 is actively recruiting participants. Contact the research team at heismail@iu.edu for enrollment information.
Where is the NCT05414409 trial being conducted?
This trial is being conducted at Indianapolis, United States.
Who is sponsoring the NCT05414409 clinical trial?
NCT05414409 is sponsored by Heba M. Ismail. The trial plans to enroll 114 participants.
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