Type 2 Diabetes and the Brain in Adolescents

September 5, 2019 updated by: Lydia Snyder, Nemours Children's Clinic

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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.

Study Type

Interventional

Enrollment (Actual)

18

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • Florida
      • Jacksonville, Florida, United States, 32207
        • Nemours Children's Health System

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

10 years to 16 years (Child, Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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)

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Diagnostic
  • Allocation: Non-Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Type 2 Diabetes
Hyperglycemic clamp and Hyperinsulinemic Euglycemic clamp
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.
No Intervention: Lean Control
Controls do not undergo Hyperglycemic clamp and Hyperinsulinemic Euglycemic clamp
No Intervention: Obese Control
Controls do not undergo Hyperglycemic clamp and Hyperinsulinemic Euglycemic clamp

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Brain Activity using functional MRI (fMRI)
Time Frame: 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.
Baseline
Neurocognitive battery metrics including IQ as well as executive function and visual-spatial memory
Time Frame: 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.
Baseline
fMRI performance in relation to dysglycemia
Time Frame: 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.
Baseline

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Nemours Children's Clinic

Investigators

  • Principal Investigator: Lydia Snyder, MD, Nemours Children's Health System

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

December 5, 2017

Primary Completion (Actual)

January 30, 2019

Study Completion (Actual)

January 30, 2019

Study Registration Dates

First Submitted

January 4, 2018

First Submitted That Met QC Criteria

March 8, 2018

First Posted (Actual)

March 12, 2018

Study Record Updates

Last Update Posted (Actual)

September 9, 2019

Last Update Submitted That Met QC Criteria

September 5, 2019

Last Verified

September 1, 2019

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 17-35

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

Undecided

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

product manufactured in and exported from the U.S.

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

Clinical Trials on Hyperglycemia

Clinical Trials on Hyperglycemic clamp

Search Similar Trials

Sponsors and Collaborators

Medical Conditions

Drug Interventions

CROs by country

CROs in Cyprus

Conditions

Rare Diseases

Drug Interventions

Dietary Supplements

Sponsor/Collaborators

Locations

3
Subscribe