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Clinical Trial Summary

The purpose of this study is to understand the role of GLP-1 in the pathogenesis of T2D in youth and explore their potential salutary effects and ability to delay the progressive loss of ß-cell function and reduce hepatic steatosis in youth with prediabetes/new onset T2D and NAFLD.

Clinical Trial Description

In a recent publication by the TODAY Group Study, it was reported that "diabetes-related complications appear early in youth-onset T2D and accumulate rapidly at a mean age of 26.4 years," and 60.1% of participants developed at least one microvascular complication. The same has been reported in RISE Studies and was suggested that the rapid decline in β-cell function and its insensitivity to two of the most frequently used treatments for T2D in pediatrics is further aggravated by the rising prevalence in NAFLD. These alarming results indicate a pressing need for effective and innovative approaches at preserving β-cell function and reducing hepatic steatosis in obese youth in order to prevent disease progression and associated complications. Kelly et al showed recently that Liraglutide 3 mg a day reduces BMI and body weight in obese adolescents. Moreover, its efficacy and safety in youth with T2D was found to be more effective than metformin. These findings provide a strong rationale for further evaluation of Liraglutide as a therapy in the context of pediatric obesity associated with prediabetes/new onset T2D and NALFD. This study will use a rigorously designed mechanistic study to determine the efficacy of Liraglutide (Victoza up to 1.8 mg) in restoring or halting the loss of beta cell function and reducing hepatic steatosis in pediatrics. The study design is a randomized, double-blind, placebo-controlled, clinical trial (RCT) using Liraglutide (Victoza up to 1.8mg) for 6 months followed by a wash-out period of 3 months. ;

Study Design

Related Conditions & MeSH terms

NCT number NCT05067621
Study type Interventional
Source Yale University
Contact Jessica Lat, MD
Phone (203) 785-2942
Email [email protected]
Status Not yet recruiting
Phase Phase 3
Start date June 2022
Completion date January 2027

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