Insulin Resistance Clinical Trial
Official title:
Insulin Resistance, Cognitive Health, and Perfusion of the Adolescent Brain
Verified date | August 2022 |
Source | University of Wisconsin, Madison |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Interventional |
The growing population of adolescents with insulin resistance (IR) is predicted to create a large public health burden in the next few decades. This study examines the function of brain blood vessels and cognitive function, to test if increasing severity of IR in adolescents is related to reduced cognitive function and reduced brain blood vessel function. Findings from this study may help create treatments to delay or prevent some of the negative effects of IR on cognitive and vascular health.
Status | Completed |
Enrollment | 18 |
Est. completion date | July 31, 2022 |
Est. primary completion date | July 31, 2022 |
Accepts healthy volunteers | Accepts Healthy Volunteers |
Gender | All |
Age group | 12 Years to 18 Years |
Eligibility | Inclusion Criteria: - Age 12-18 years inclusive - Typically developing and cognitively intact Exclusion Criteria: - Diabetes (=126 mg dL-1 fasting glucose) - Insulin treatment or sensitizing drugs - Diagnosis of kidney, pulmonary, or heart disease - Current smoking (defined as use of nicotine >5 times in the past month) - Pregnancy - Neurological or developmental disorders (e.g., intellectual disability, autism) - Significant head injury or medical conditions (e.g., concussion, encephalopathy, seizure disorder) - Inability to undergo the MRI procedure - Weight less than 94.5 lbs (42.9 kg) to adhere to safety guidelines regarding blood sampling and OGTT administration - Tanner Stage <3 - Any other circumstance deemed by the PI not addressed above |
Country | Name | City | State |
---|---|---|---|
United States | University of Wisconsin-Madison | Madison | Wisconsin |
Lead Sponsor | Collaborator |
---|---|
University of Wisconsin, Madison | Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD) |
United States,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Cognitive Function as determined by WASI (Verbal IQ) | Participants will undergo a series of cognitive tests to evaluate intelligence, memory, speed function, executive function, and psychiatric quality of life. The results of these test will be scored and reported individually.
The Wechsler Abbreviated Scale of Intelligence (WASI) for Verbal IQ is composed of 2 of the 4 WASI subtests: 31-item Vocabulary and 24-item Similarities. The total range of possible scores is 40-160; the higher the score, the higher the Verbal IQ. |
up to 1 day | |
Primary | Cognitive Function as determined by WASI (Performance IQ) | Participants will undergo a series of cognitive tests to evaluate intelligence, memory, speed function, executive function, and psychiatric quality of life. The results of these test will be scored and reported individually.
The Wechsler Abbreviated Scale of Intelligence (WASI) for Performance IQ is composed of 2 of the 4 WASI subtests: 13-item Block Design and 30-item Matrix Reasoning. The total range of possible scores is 40-160, the higher the score, the higher the Performance IQ. |
up to 1 day | |
Primary | Cognitive Function as determined by NIH Toolbox (List Learning) Test | Participants will undergo a series of cognitive tests to evaluate intelligence, memory, speed function, executive function, and psychiatric quality of life. The results of these test will be scored and reported individually.
The NIH Toolbox (List Learning) Test assesses working memory by having participants sort images by size order. The total range of possible score is 0-28, with higher scores indicating more improved working memory. |
up to 1 day | |
Primary | Cognitive Function as determined by NIH Toolbox (Oral Symbol Digit Test) | Participants will undergo a series of cognitive tests to evaluate intelligence, memory, speed function, executive function, and psychiatric quality of life. The results of these test will be scored and reported individually.
The NIH Toolbox (Oral Symbol Digit Test) assesses processing speed. The total range of possible scores is 0-144, the higher the score, the faster the processing speed. |
up to 1 day | |
Primary | Cognitive Function as determined by NIH Toolbox (Flanker Inhibitory Control and Attention) | Participants will undergo a series of cognitive tests to evaluate intelligence, memory, speed function, executive function, and psychiatric quality of life. The results of these test will be scored and reported individually.
The NIH Toolbox (Flanker Inhibitory Control and Attention) assess executive attention. It is a visual display using a central arrow flanked by arrows either pointing in the same direction or different that the central arrow. The participant is to indicate the direction of the central arrow when they are all pointing in the same direction. Scoring is algorithm derived and based on accuracy and reaction time, with a total range of possible scores 0-10 with higher scores indicating increased executive attention. |
up to 1 day | |
Primary | Cognitive Function as determined by NIH Toolbox (Pattern Completion) | Participants will undergo a series of cognitive tests to evaluate intelligence, memory, speed function, executive function, and psychiatric quality of life. The results of these test will be scored and reported individually.
The NIH Toolbox (Pattern Completion) assesses processing speed by asking participants to indicate if visual stimuli are the same or not the same. This test is scored by the total number of correct responses in 90 seconds (maximum score is 130). The higher the score, the better the processing speed. |
up to 1 day | |
Primary | Cognitive Function as determined by NIH Toolbox (Picture Sequence) | Participants will undergo a series of cognitive tests to evaluate intelligence, memory, speed function, executive function, and psychiatric quality of life. The results of these test will be scored and reported individually.
The NIH Toolbox (Picture Sequence) assesses episodic memory. Participants are shown a series of pictures one at a time, related to a single theme. After the last picture is shown, the participants is asked to place the pictures in the demonstrated sequence. The total number of correct placements across 3 trials provides the score, up to a maximum of 48. The higher the score, the better the episodic memory. |
up to 1 day | |
Primary | Cognitive Function as determined by WRAML (Picture Memory) | Participants will undergo a series of cognitive tests to evaluate intelligence, memory, speed function, executive function, and psychiatric quality of life. The results of these test will be scored and reported individually.
The Wide Range Assessment of Memory and Learning (WRAML) (Picture Memory Recognition) assesses visual memory function by asking participants to recall altered information from 4 pictures. Scoring is based on the number of correct items, up to a maximum of 51. The higher the score, the better the visual memory. |
up to 1 day | |
Primary | Cognitive Function as determined by D-KEFS (Color-Word Interference) | Participants will undergo a series of cognitive tests to evaluate intelligence, memory, speed function, executive function, and psychiatric quality of life. The results of these test will be scored and reported individually.
The Delis-Kaplan Executive Function System (D-KEFS) (Color-Word Interference) test assesses executive function and consists of 4 parts: color naming, word reading, inhibition, and inhibition/switching. Test performance is measured by completion time and errors on each part. Raw scores are converted to norm-referenced scaled scores adjusted for age and education. These scores are aligned with a population mean of 10, and standard deviation of 3. Higher scores indicate better executive function. |
up to 1 day | |
Primary | Cognitive Function as determined by D-KEFS (Trail Making Test) | Participants will undergo a series of cognitive tests to evaluate intelligence, memory, speed function, executive function, and psychiatric quality of life. The results of these test will be scored and reported individually.
The Delis-Kaplan Executive Function System (D-KEFS) (Trail Making Test) assesses executive function using visual scanning, number sequencing, letter sequencing, number-letter switching, and motor speed. Performance time is measured, with lower times indicative of higher executive function. |
up to 1 day | |
Primary | Cognitive Function as determined by PedsQL - (Child 8-12/Teen 13-18) | Participants will undergo a series of cognitive tests to evaluate intelligence, memory, speed function, executive function, and psychiatric quality of life. The results of these test will be scored and reported individually.
The Pediatric Quality of Life Inventory (PedsQL) is a 23-item survey assessing 4 functional dimensions: Physical, Emotional, Social, and School. Each item is scored on a 5-point Likert scale where 0 is 'not at all' and 4 is 'almost always'. Items are reversed scored (0=100, 1=75, 2=50, 3=25, 4=0) and linearly transformed to a 1-100 scale, where the higher the score, the better the Quality of Life. |
up to 1 day | |
Primary | Cerebral blood flow as determined by MRI | CBF will be measured via MRI before OGTT (baseline) and after OGTT at 55 minutes. | up to 1 day | |
Primary | Mediation analysis between insulin resistance, cerebral blood flow, and cognitive function | Following relationships will be tested via linear regression:
insulin resistance and cerebral blood flow; cerebral blood flow and cognitive tests; and insulin resistance and cognitive tests with cerebral blood flow as the mediator |
through study completion (up to 2 years) |
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