Type 2 Diabetes and the Brain in Adolescents

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

18 participants

Study Classification

INTERVENTIONAL

Study Start Date

2017-12-05

Study Completion Date

2019-01-30

Brief Summary

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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.

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Detailed Description

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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

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Type 2 Diabetes Mellitus Obesity Pediatric Obesity Insulin Resistance Dysglycemia Hyperglycemia

Study Design

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Allocation Method

NON_RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

DIAGNOSTIC

Blinding Strategy

NONE

Study Groups

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Type 2 Diabetes

Hyperglycemic clamp and Hyperinsulinemic Euglycemic clamp

Group Type EXPERIMENTAL

Hyperglycemic clamp

Intervention Type PROCEDURE

Subjects with T2D will receive IV Dextrose infusion to maintain plasma glucose at \~250 mg/dL during fMRI.

Hyperinsulinemic Euglycemic clamp

Intervention Type PROCEDURE

Subjects with T2D will receive IV Dextrose and Insulin infusion to maintain plasma glucose at approximately 90 mg/dL during fMRI.

Lean Control

Controls do not undergo Hyperglycemic clamp and Hyperinsulinemic Euglycemic clamp

Group Type NO_INTERVENTION

No interventions assigned to this group

Obese Control

Controls do not undergo Hyperglycemic clamp and Hyperinsulinemic Euglycemic clamp

Group Type NO_INTERVENTION

No interventions assigned to this group

Interventions

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Hyperglycemic clamp

Subjects with T2D will receive IV Dextrose infusion to maintain plasma glucose at \~250 mg/dL during fMRI.

Intervention Type 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.

Intervention Type PROCEDURE

Eligibility Criteria

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Inclusion Criteria

Type 2 Diabetes:

* BMI ≥85th percentile
* A1c ≥ 8%
* Pubertal

Healthy Controls:

* BMI ≥85th percentile for Obese Controls
* BMI \< 85th percentile for Lean Controls
* Pubertal
* Normal A1c \& Fasting glucose

Exclusion Criteria

* 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)

Minimum Eligible Age

12 Years

Maximum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes