Status:
COMPLETED
Type 2 Diabetes and the Brain in Adolescents
Lead Sponsor:
Nemours Children's Clinic
Conditions:
Type 2 Diabetes Mellitus
Obesity
Eligibility:
All Genders
12-18 years
Phase:
NA
Brief 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 chan...
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) f...
Eligibility Criteria
Inclusion
- 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
- 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)
Key Trial Info
Start Date :
December 5 2017
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
January 30 2019
Estimated Enrollment :
18 Patients enrolled
Trial Details
Trial ID
NCT03461510
Start Date
December 5 2017
End Date
January 30 2019
Last Update
September 9 2019
Active Locations (1)
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1
Nemours Children's Health System
Jacksonville, Florida, United States, 32207