NCT03461510

Type 2 Diabetes and the Brain in Adolescents

Dysglycemia & Obesity: Impact on the Brain in Adolescents With Type 2 Diabetes

• Status: Completed
• Phase: N/A
• Study type: Interventional
• Enrollment: 18 (actual)
• Sponsor: Nemours Children's Clinic · Academic / Other
• Sex: All
• Age: 12 Years – 18 Years
• Healthy volunteers: Accepted

Summary

This study evaluates differences in brain function and cognitive performance in adolescents with type 2 diabetes (T2D) compared to non diabetic controls (both obese and lean) and correlates these changes with obesity, insulin resistance, and glycemic control in youth with T2D.

Detailed description

This is a cross-sectional study examining neurocognitive function and brain activity in resting state and during working memory and executive function tasks using blood oxygen level dependent (BOLD) functional MRI (fMRI) during hyperinsulinemic euglycemic and hyperglycemic clamps in obese adolescents with T2D compared to non-diabetic obese and lean controls. The investigators will measure glycemic control (acute hyperglycemia during clamps and glycemic variability) and insulin resistance to examine their association with neurocognitive metrics and brain functional activity. There will be one screening visit and three study visits for subjects with T2D. One visit will consist of neurocognitive testing and dual energy X-ray absorptiometry (DEXA) of the whole body to assess body composition including fat mass. In the other two visits, subjects with T2D will undergo normal and high glucose clamps during fMRI. Obese and lean control subjects will have one screening visit and two study visits, one for neurocognitive testing and DEXA and another for fMRI without glucose clamps. All subjects will have a blood sample obtained at the screening visit. Only adolescents with type 2 diabetes will wear a continuous glucose monitor (CGM) for 6 days prior to neuroimaging to determine glycemic variability. A1C will be assessed at baseline. Parents of subjects will also have abbreviated IQ testing.

Conditions

• Type 2 Diabetes Mellitus
• Obesity
• Pediatric Obesity
• Insulin Resistance
• Dysglycemia
• Hyperglycemia

Interventions

Type	Name	Description
PROCEDURE	Hyperglycemic clamp	Subjects with T2D will receive IV Dextrose infusion to maintain plasma glucose at \~250 mg/dL during fMRI.
PROCEDURE	Hyperinsulinemic Euglycemic clamp	Subjects with T2D will receive IV Dextrose and Insulin infusion to maintain plasma glucose at approximately 90 mg/dL during fMRI.

Timeline

• Start date: 2017-12-05
• Primary completion: 2019-01-30
• Completion: 2019-01-30
• First posted: 2018-03-12
• Last updated: 2019-09-09

Locations

1 site across 1 country: United States