NCT05414409 · Heba M. Ismail
The Gut Microbiome in Type 1 Diabetes and Mechanism of Metformin Action
What this study is about
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.
View original scientific 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.
Interventions
DRUG
Metformin
Metformin is an oral medication that improves insulin sensitivity.
Primary outcome measures
Differences in the gut microbiome in lean and overweight/obese youth with type 1 diabetes
Time frame: Baseline
cross sectional comparison of stool microbiome using metagenomic sequencing data
Differences in the gut microbial metabolites in lean and overweight/obese youth with type 1 diabetes
Time frame: Baseline
The investigators will measure and compare the stool and serum short chain fatty acids using mass spectrometry
Differences in the gut microbial metabolites in lean and overweight/obese youth with type 1 diabetes
Time frame: Baseline
The investigators will measure and compare the stool and serum secondary bile acids using mass spectrometry
Changes in the gut microbiome in overweight/obese youth with type 1 diabetes in response to metformin
Time frame: Baseline, Month 3, and Month 6
longitudinal comparison before and after taking metformin for 6 months, stool samples will be collected at baseline, 3 months and 6 months and sequenced for microbiome profile using metagenomic sequencing
Changes in the gut microbial metabolites in overweight/obese youth with type 1 in response to metformin
Time frame: Baseline, Month 3, and Month 6
The investigators will measure and compare the stool and serum metabolites (short chain fatty acids and secondary bile acids) before, during and after 6 months of daily metformin therapy using mass spectrometry
Who can participate
This study lists these criteria on ClinicalTrials.gov. A study coordinator reviews eligibility during screening — this page does not determine whether you qualify.
Inclusion criteria
- 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.
Exclusion criteria
- 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.
- Participation in any research intervention trials within the past 3 months.
- History of treatment or use of metformin, a type 2 diabetes medication.
Where
- Indianapolis, Indiana
Collaborators
National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)
Related conditions & keywords
Frequently asked questions
What is a clinical trial?
A clinical trial is a research study that tests new medical treatments, drugs, devices, or procedures to determine their safety and effectiveness. Trials are carefully designed and monitored to protect participants while advancing medical knowledge.
Is it safe to participate?
Clinical trials follow strict safety guidelines and ethical standards. Trials must be reviewed and approved, and participants are closely monitored by medical professionals throughout the study. You can withdraw at any time if you choose.
Will I be compensated?
Many clinical trials offer compensation for your time, travel expenses, and inconvenience. The specific compensation varies by study and will be discussed during the screening process. All study-related medical care is typically provided at no cost to participants.
Will I receive a placebo instead of treatment?
When effective treatment exists, participants typically receive either the standard treatment plus the study intervention, or the standard treatment plus placebo. You would not be denied effective care. Placebos are primarily used when no proven treatment is available, or in addition to standard care. Your trial consent form will clearly explain what treatments you may receive.
Can I leave a trial if I change my mind?
Absolutely. Participation in clinical trials is completely voluntary. You have the right to withdraw from the study at any time, for any reason, without penalty or loss of benefits to which you are otherwise entitled.
How long does a clinical trial last?
Trial duration varies widely depending on the study design and purpose. Some trials last just a few weeks, while others may continue for months or years. The study coordinator will provide specific timeline information during your screening call.
Data: ClinicalTrials.gov · synced Jul 25, 2025 · Source of record for eligibility and locations