Obesity Clinical Trial
Official title:
Dysglycemia & Obesity: Impact on the Brain in Adolescents With Type 2 Diabetes
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.
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.
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