Dysglycemia & Obesity: Impact on the Brain in Adolescents With Type 2 Diabetes
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 18
- 试验地点
- 2
- 主要终点
- Brain Activity using functional MRI (fMRI)
研究概览
简要总结
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.
详细描述
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.
研究设计
- 研究类型
- Interventional
- 分配方式
- Non Randomized
- 干预模型
- Parallel
- 主要目的
- Diagnostic
- 盲法
- None
入排标准
- 年龄范围
- 12 Years 至 18 Years（Child, Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Type 2 Diabetes:
- •BMI ≥85th percentile
- •Healthy Controls:
- •BMI ≥85th percentile for Obese Controls
- •BMI < 85th percentile for Lean Controls
- •Normal A1c & Fasting glucose
排除标准
- •Significant developmental delay or learning disability
- •Significant visual or auditory deficits
- •Born <34 weeks gestation
- •Neurologic disease
- •Psychiatric disease requiring inpatient treatment
- •Significant head trauma
- •Malignancy
- •Pregnancy
- •Weight > 350lb (MRI weight limit)
- •Metal in the body (including dental braces)
研究组 & 干预措施
Type 2 Diabetes
Hyperglycemic clamp and Hyperinsulinemic Euglycemic clamp
干预措施: Hyperglycemic clamp (Procedure)
Type 2 Diabetes
Hyperglycemic clamp and Hyperinsulinemic Euglycemic clamp
干预措施: Hyperinsulinemic Euglycemic clamp (Procedure)
Lean Control
Controls do not undergo Hyperglycemic clamp and Hyperinsulinemic Euglycemic clamp
Obese Control
Controls do not undergo Hyperglycemic clamp and Hyperinsulinemic Euglycemic clamp
结局指标
主要结局
Brain Activity using functional MRI (fMRI)
时间窗: Baseline
The investigators will examine functional connectivity of brain networks during cross sectional resting-state and task-related (working memory and response inhibition) BOLD-fMRI activation. fMRI activation in adolescents with T2D will be compared to age- and sex- matched, non-diabetic, healthy lean and obese controls.
Neurocognitive battery metrics including IQ as well as executive function and visual-spatial memory
时间窗: Baseline
The investigators will evaluate cognitive performance by examining test scores from neurocognitive metrics which reflect global IQ, spatial recognition, episodic memory, executive function (includes response inhibition, working memory), academic achievement, and processing speed. Adolescents with T2D will be compared to controls to determine whether these differences are associated with glycemic control, obesity, and insulin resistance.
fMRI performance in relation to dysglycemia
时间窗: Baseline
In adolescents with T2D, the investigators will examine BOLD-fMRI brain activation in relation to acute hyperglycemia during glucose clamping, chronic hyperglycemia, glycemic variability, and insulin resistance.
次要结局
未报告次要终点
研究者
Lydia Snyder
MD
Nemours Children's Clinic