Obesity Clinical Trial
Official title:
Dysglycemia & Obesity: Impact on the Brain in Adolescents With Type 2 Diabetes
NCT number | NCT03461510 |
Other study ID # | 17-35 |
Secondary ID | |
Status | Completed |
Phase | N/A |
First received | |
Last updated | |
Start date | December 5, 2017 |
Est. completion date | January 30, 2019 |
Verified date | September 2019 |
Source | Nemours Children's Clinic |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Interventional |
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.
Status | Completed |
Enrollment | 18 |
Est. completion date | January 30, 2019 |
Est. primary completion date | January 30, 2019 |
Accepts healthy volunteers | Accepts Healthy Volunteers |
Gender | All |
Age group | 12 Years to 18 Years |
Eligibility |
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) |
Country | Name | City | State |
---|---|---|---|
United States | Nemours Children's Health System | Jacksonville | Florida |
Lead Sponsor | Collaborator |
---|---|
Nemours Children's Clinic |
United States,
Bruehl H, Sweat V, Tirsi A, Shah B, Convit A. Obese Adolescents with Type 2 Diabetes Mellitus Have Hippocampal and Frontal Lobe Volume Reductions. Neurosci Med. 2011 Mar 1;2(1):34-42. — View Citation
Cui Y, Jiao Y, Chen YC, Wang K, Gao B, Wen S, Ju S, Teng GJ. Altered spontaneous brain activity in type 2 diabetes: a resting-state functional MRI study. Diabetes. 2014 Feb;63(2):749-60. doi: 10.2337/db13-0519. Epub 2013 Dec 18. — View Citation
Marder TJ, Flores VL, Bolo NR, Hoogenboom WS, Simonson DC, Jacobson AM, Foote SE, Shenton ME, Sperling RA, Musen G. Task-induced brain activity patterns in type 2 diabetes: a potential biomarker for cognitive decline. Diabetes. 2014 Sep;63(9):3112-9. doi: 10.2337/db13-1783. Epub 2014 Apr 4. — View Citation
Marzelli MJ, Mazaika PK, Barnea-Goraly N, Hershey T, Tsalikian E, Tamborlane W, Mauras N, White NH, Buckingham B, Beck RW, Ruedy KJ, Kollman C, Cheng P, Reiss AL; Diabetes Research in Children Network (DirecNet). Neuroanatomical correlates of dysglycemia in young children with type 1 diabetes. Diabetes. 2014 Jan;63(1):343-53. doi: 10.2337/db13-0179. Epub 2013 Oct 29. — View Citation
Mauras N, Mazaika P, Buckingham B, Weinzimer S, White NH, Tsalikian E, Hershey T, Cato A, Cheng P, Kollman C, Beck RW, Ruedy K, Aye T, Fox L, Arbelaez AM, Wilson D, Tansey M, Tamborlane W, Peng D, Marzelli M, Winer KK, Reiss AL; Diabetes Research in Children Network (DirecNet). Longitudinal assessment of neuroanatomical and cognitive differences in young children with type 1 diabetes: association with hyperglycemia. Diabetes. 2015 May;64(5):1770-9. doi: 10.2337/db14-1445. Epub 2014 Dec 8. — View Citation
Mazaika PK, Weinzimer SA, Mauras N, Buckingham B, White NH, Tsalikian E, Hershey T, Cato A, Aye T, Fox L, Wilson DM, Tansey MJ, Tamborlane W, Peng D, Raman M, Marzelli M, Reiss AL; Diabetes Research in Children Network (DirecNet). Variations in Brain Volume and Growth in Young Children With Type 1 Diabetes. Diabetes. 2016 Feb;65(2):476-85. doi: 10.2337/db15-1242. Epub 2015 Oct 28. — View Citation
Yau PL, Javier DC, Ryan CM, Tsui WH, Ardekani BA, Ten S, Convit A. Preliminary evidence for brain complications in obese adolescents with type 2 diabetes mellitus. Diabetologia. 2010 Nov;53(11):2298-306. doi: 10.1007/s00125-010-1857-y. Epub 2010 Jul 30. — View Citation
Yau PL, Kang EH, Javier DC, Convit A. Preliminary evidence of cognitive and brain abnormalities in uncomplicated adolescent obesity. Obesity (Silver Spring). 2014 Aug;22(8):1865-71. doi: 10.1002/oby.20801. Epub 2014 May 28. — View Citation
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Brain Activity using functional MRI (fMRI) | 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 | |
Primary | Neurocognitive battery metrics including IQ as well as executive function and visual-spatial memory | 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 | |
Primary | fMRI performance in relation to dysglycemia | 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 |
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