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The Gut Microbiome in Type 1 Diabetes and Mechanism of Metformin Action

Launched by HEBA M. ISMAIL · Jun 8, 2022

Trial Information

Current as of August 19, 2025

Recruiting

Keywords

ClinConnect Summary

This clinical trial is investigating how the gut microbiome, which is the community of bacteria in our digestive system, affects young people with Type 1 diabetes (T1D) who are also dealing with obesity. The researchers want to understand how these factors influence the management of T1D and how a medication called metformin might work differently in these patients. By studying these connections, the trial hopes to find new ways to help manage T1D and improve health outcomes for young people.

To participate in this study, you need to be between 11 and 18 years old and either obese or lean with a diagnosis of Type 1 diabetes. However, if you have certain other types of diabetes, recent infections, or specific gastrointestinal diseases, you may not be eligible. If you join the trial, you can expect to provide information about your health and possibly take part in tests that help researchers learn more about your gut health and diabetes management. This study is currently looking for participants, and your involvement could contribute to important findings that benefit others with similar health challenges.

Gender

ALL

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.

About Heba M. Ismail

Heba M. Ismail is a dedicated clinical trial sponsor with a focus on advancing medical research and improving patient outcomes through innovative studies. With a robust background in clinical operations and regulatory compliance, Ms. Ismail leads and oversees various clinical trials, ensuring adherence to ethical standards and regulatory requirements. Her commitment to fostering collaboration among multidisciplinary teams and stakeholders enhances the efficiency and effectiveness of trial execution. By prioritizing patient safety and data integrity, she aims to contribute to the development of groundbreaking therapies and enhance the overall quality of healthcare.

Locations

Indianapolis, Indiana, United States

Patients applied

0 patients applied

Timeline

First submit

Trial launched

Trial updated

Estimated completion

Not reported

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