Profiling of the Gut Microbiome in Overweight Youth with T1D and Associations with Biomarkers of b-cell Stress and Death.
Investigating the Gut Microbiome in Youths with Type 1 Diabetes: A Condition Where the Body's Immune System Attacks Insulin-Producing Cells
Brief description of study.
Aim 1 of the study is to profile the gut microbiome in youths with type 1 diabetes according to their body mass index. The central hypothesis is that the gut microbiome will be altered in obese vs. lean youths with T1D (and when compared to healthy non-diabetic lean and obese youths) and that this could be related to differences in β-cell stress/death. Type 1 diabetes (T1D) is an autoimmune disease characterized by progressive β-cell loss with eventual dependence on exogenous insulin. Our long-term goal is to understand the role of the gut microbiome in the development of T1D in obese and lean individuals, which would ultimately lead to a more targeted therapeutic approaches in those individuals.
Aim 2 is to determine if differences in the gut microbiome profile are associated with differences in measures of β-cell stress/death.
Eligibility of study
You may be eligible for this study if you meet the following criteria:
- Conditions: Healthy volunteers and obese youth.
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Age: 11 years - 18 years
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Gender: All
Inclusion:
1) Obese youths 11-18 years of age with T1D at time of diagnosis and at time of enrollment.
2) Lean youths 11-18 years of age with T1D at time of diagnosis and at time of enrollment.
Exclusion:
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 3 months;
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, 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.
This study investigates the gut microbiome in youths with Type 1 Diabetes (T1D) based on their body mass index. Type 1 Diabetes is an autoimmune condition where the body's immune system attacks insulin-producing cells, leading to a need for insulin therapy. The study aims to find out if the gut microbiome, which is the community of microorganisms living in the intestines, is different in obese versus lean youths with T1D compared to healthy youths.
Participants will undergo procedures to analyze their gut microbiome and measure levels of beta-cell stress or death. Beta-cells are cells in the pancreas that make insulin. The study will look at whether changes in the microbiome are linked to how much stress or death these cells experience.
- Who can participate: Youths aged 11-18 years with Type 1 Diabetes at the time of diagnosis and enrollment can participate. Participants must be either obese or lean and should not have Type 2 Diabetes, ongoing infections, or a history of certain medical conditions or treatments.
- Study details: Participants will provide samples for analysis of their gut microbiome. The study will compare these samples to see if there are differences based on body weight and diabetic status. A placebo is not used in this study.
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