RISE Pediatric Medication Study

Conditions

Prediabetes | Type 2 Diabetes

What is the purpose of this trial?

The RISE Pediatric Medication Study is a 2-arm, 4-center, clinical trial of children with prediabetes and early type 2 diabetes to address the hypothesis that aggressive glucose lowering will lead to recovery of beta-cell function that will be sustained after withdrawal of treatment. Pediatric participants (ages 10-19) will be randomized to one of the following treatment regimens: (1) metformin alone or (2) early intensive treatment with basal insulin glargine followed by metformin.

The primary clinical question RISE will address is: Are improvements in ß-cell function following 12 months of active treatment maintained for 3 months following the withdrawal of therapy? Secondary outcomes will assess durability of glucose tolerance following withdrawal of therapy, and whether biomarkers obtained in the fasting state predict parameters of ß-cell function, insulin sensitivity and glucose tolerance and the response to an intervention.


Participation Guidelines

Age:
10 Years - 19 Years
Gender:
Both

Click here for detailed information about who can participate in this trial.


Sponsor:
National Institutes of Health
Dates:
04/04/2013
Last Updated:
Study HIC#:
1212011187