RECRUITING

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

Study Overview

This clinical trial focuses on testing the efficacy of different digital interventions to promote re-engagement in cancer-related long-term follow-up care for adolescent and young adult (AYA) survivors of childhood cancer.

Description

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.

Official Title

The Gut Microbiome in Lean and Overweight Youth With Type 1 Diabetes and Novel Mechanism of Action of Metformin

Quick Facts

Study Start:2022-09-30
Study Completion:2026-11-02
Study Type:Not specified
Phase:Not Applicable
Enrollment:Not specified
Status:RECRUITING

Study ID

NCT05414409

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Ages Eligible for Study:11 Years to 18 Years
Sexes Eligible for Study:ALL
Accepts Healthy Volunteers:No
Standard Ages:CHILD, ADULT
Inclusion CriteriaExclusion Criteria
  1. 1. Overweight/obese youth 11-18 years of age with T1D at time of enrollment.
  2. 2. Lean youth 11-18 years of age with T1D at time of enrollment.
  1. 1. Known monogenic forms of diabetes or Type 2 diabetes (confirmed clinically and by genetic/antibody testing).
  2. 2. History of ongoing infection or antibiotic treatment within the past month;
  3. 3. History of immune-compromise, recurrent infections, steroid intake (inhaled or oral forms) or other immunosuppressant use in the past 6 months.
  4. 4. History of chronic gastrointestinal disease and active within the past 6 months, possible or confirmed celiac disease.
  5. 5. Participation in any research intervention trials within the past 3 months.
  6. 6. History of treatment or use of metformin, a type 2 diabetes medication.

Contacts and Locations

Study Contact

Heba M Ismail
CONTACT
317-274-2114
heismail@iu.edu
HI Team
CONTACT
317-274-2114
hiteam@iu.edu

Study Locations (Sites)

Indiana University School of Medicine
Indianapolis, Indiana, 46202
United States

Collaborators and Investigators

Sponsor: Heba M. Ismail

Study Record Dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Registration Dates

Study Start Date2022-09-30
Study Completion Date2026-11-02

Study Record Updates

Study Start Date2022-09-30
Study Completion Date2026-11-02

Terms related to this study

Additional Relevant MeSH Terms

  • Type 1 Diabetes
  • Obesity