NCT03960333

Immunometabolism in Pediatric Obesity

• Status: Completed
• Phase: —
• Study type: Observational
• Enrollment: 82 (actual)
• Sponsor: Arkansas Children's Hospital Research Institute · Academic / Other
• Sex: All
• Age: 5 Years – 17 Years
• Healthy volunteers: —

Summary

This is a study to learn about obesity and how insulin resistance and Type 2 Diabetes develops in children.

Detailed description

The main purpose of this proposed study is to determine whether the immunometabolic phenotypes of CD4+T cells from obese children is skewed towards Teff with mTOR-driven glycolysis and away from Tregs with AMPK-driven OXPHOS and whether metformin can reverse the immunometabolic phenotypes. This study consists of: 1. An observational cross sectional immune and metabolic analysis of several groups of children including lean, overweight/obese, and T2D. 2. A prospective immune and metabolic analysis of newly diagnosed children with T2D or insulin resistance who will be or were recently prescribed metformin as part of their clinical care. Children with T2D or insulin resistance who will be or were recently prescribed metformin, will be asked to complete two study visits. If completed, the second visit will occur 6 months (+/- 2 weeks) after beginning metformin as part of their clinical care. All other children, will be asked to complete only the first visit.

Conditions

• Obesity
• Type 2 Diabetes Mellitus
• Insulin Resistance

Timeline

• Start date: 2019-04-25
• Primary completion: 2021-02-05
• Completion: 2024-06-30
• First posted: 2019-05-23
• Last updated: 2025-02-13

Locations

1 site across 1 country: United States