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.
Study Type
INTERVENTIONAL
Allocation
NON_RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Enrollment
114
Metformin is an oral medication that improves insulin sensitivity.
Indiana University School of Medicine
Indianapolis, Indiana, United States
RECRUITINGDifferences in the gut microbiome in lean and overweight/obese youth with type 1 diabetes
cross sectional comparison of stool microbiome using metagenomic sequencing data
Time frame: Baseline
Differences in the gut microbial metabolites in lean and overweight/obese youth with type 1 diabetes
The investigators will measure and compare the stool and serum short chain fatty acids using mass spectrometry
Time frame: Baseline
Differences in the gut microbial metabolites in lean and overweight/obese youth with type 1 diabetes
The investigators will measure and compare the stool and serum secondary bile acids using mass spectrometry
Time frame: Baseline
Changes in the gut microbiome in overweight/obese youth with type 1 diabetes in response to metformin
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
Time frame: Baseline, Month 3, and Month 6
Changes in the gut microbial metabolites in overweight/obese youth with type 1 in response to metformin
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
Time frame: Baseline, Month 3, and Month 6
Differences in measures of C-peptide as a measure of beta cell health in lean and overweight/obeseT1D youth
The investigators will measure serum C-peptide to calculate a ratio of proinsulin to C-peptide as a marker of beta cell health. These measures will then be compared between the lean and obese T1D youth.
This platform is for informational purposes only and does not constitute medical advice. Always consult a qualified healthcare professional.
Time frame: Baseline
Differences in measures Proinsulin as a measure of beta cell health in lean and overweight/obeseT1D youth
The investigators will measure serum proinsulin and calculate a ratio of proinsulin to C-peptide as a marker of beta cell health. These measures will then be compared between the lean and obese T1D youth.
Time frame: Baseline
Differences in measures of insulin sensitivity in lean and overweight/obese T1D youth
Insulin sensitivity will be assessed in individuals using the estimated insulin sensitivity score (eIS), which is based on waist circumference (cm), HbA1c (%) and triglycerides (mg/dl)
Time frame: Baseline
Changes in measures of C-peptide as a measure of beta cell health in overweight/obese T1D youth in response to metformin
Serum C-peptide will be used to calculate proinsulin to C-peptide ratio as a measure of beta cell health before and after metformin therapy
Time frame: Baseline, Month 3, and Month 6
Changes in measures of proinsulin as a measure of beta cell health in overweight/obese T1D youth in response to metformin
Serum proinsulin will be used to calculate proinsulin to C-peptide ratio as a measure of beta cell health before and after metformin therapy
Time frame: Baseline, Month 3, and Month 6
Changes in measures of insulin sensitivity in overweight/obese T1D youth in response to metformin
Estimated insulin sensitivity score will be used to assess response metformin therapy
Time frame: Baseline, Month 3, and Month 6
Changes in measures of beta cell function using a timed mixed meal tolerance test
Participants in the metformin trial will undergo a standard 2-hour mixed meal tolerance test at baseline and after 6 months of oral metformin therapy
Time frame: Baseline and Month 6