This trial looks at the role of the gut microbiome in type 1 diabetes in obese youth, and whether modifying the microbiome can help manage the disease.
- Type 1 Diabetes
4 Primary · 7 Secondary · Reporting Duration: 3 years
Side Effects for
2 Treatment Groups
Comparison of microbiome by BMI Category
1 of 2
1 of 2
114 Total Participants · 2 Treatment Groups
Primary Treatment: Metformin · No Placebo Group · Phase 2
Who is running the clinical trial?
Age 11 - 18 · All Participants · 2 Total Inclusion CriteriaMark “Yes” if the following statements are true for you:
Frequently Asked Questions
Is enrollment for this study currently open?
"Indeed, the most recent update on clinicaltrials.gov states that this research trial is not currently recruiting participants; it was initially posted October 1st 2022 and modified September 16th of the same year. However, there are 2146 other active medical studies actively seeking candidates at present." - Anonymous Online Contributor
Is this investigation enlisting participants aged 65 or older?
"This clinical trial is open to those between 11 and 18 years old. The number of trials available for minors stands at 410, which significantly outnumbers the 1465 studies targeting seniors." - Anonymous Online Contributor
What potential risks does Metformin pose to individuals?
"Metformin's safety has been partially verified, so it earned a rating of 2. This is because Phase 2 trials have demonstrated some evidence for its safety but none regarding efficacy." - Anonymous Online Contributor
What outcomes are researchers aiming to demonstrate with this research endeavor?
"This medical study, which is expected to take around 2 years, will primarily measure the differences in gut microbial metabolites in lean and obese youth with type 1 diabetes. Secondary assessments include changes of insulin sensitivity among overweight T1D patients taking metformin; a comparison between proinsulin levels as an indicator of beta cell health in slim and plump children afflicted with this illness; and contrasting C-peptide measurements for also assessing beta cell health between chubby and slender youngsters suffering from type 1 diabetes." - Anonymous Online Contributor
What patient criteria must be met to participate in this experiment?
"This clinical trial is calling for 114 obese minors aged 11 to 18 who have type 1 diabetes. To be accepted into the study, applicants must meet two requirements: they must possess T1D when enrolling and either an obesity or lean BMI at the time of enrollment." - Anonymous Online Contributor