The Gut Microbiome in Type 1 Diabetes and Mechanism of Metformin Action
Trial statusRecruiting
Trial phasePhase 2
Trial typeInterventional
Biological sexAll
Age11-18
SponsorHeba M. Ismail
About this trial
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
Qualifiers
Overweight/obese youth 11-18 years of age with T1D at time of enrollment.
Lean youth 11-18 years of age with T1D at time of enrollment.
Disqualifiers
Known monogenic forms of diabetes or Type 2 diabetes (confirmed clinically and by genetic/antibody testing).
History of ongoing infection or antibiotic treatment within the past month;
History of immune-compromise, recurrent infections, steroid intake (inhaled or oral forms) or other immunosuppressant use in the past 6 months.
History of chronic gastrointestinal disease and active within the past 6 months, possible or confirmed celiac disease.
Trial design
Treatments tested in this trial
- Metformin
Treatment groups
114 Participants
are divided into 2 treatment groupsSponsors and collaborators
Heba M. Ismail
Lead sponsor
Indiana University
Sponsor institution
National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)
Collaborator
Source ClinicalTrials.gov