Exercise in Adolescents With Insulin Resistance

NCT04154865 | Terminated

• 4 other identifiers: 2019-0838A176000EDUC/KINESIOLOGYProtocol Version 2/10/2023
• Study Type: interventional
• Target: 15
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Insulin Resistance

Outcome Measures

Primary Outcomes (9)

• Cognitive Function as determined by NIH Toolbox Picture Vocabulary 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 Picture Vocabulary Test assesses the mental processes that translate thought into symbols (words, gestures) that can be shared among individuals for purposes of communication. The respondent is presented with an audio recording of a word and four photographic images on the computer screen and is asked to select the picture that most closely matches the meaning of the word. This test is scored by the total number of correct responses with a total range of possible scores 0-130 with higher scores indicating better vocabulary skills.

  up to 1 day

• Cognitive Function as determined by NIH Flanker Inhibitory Control and Attention 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 Flanker Inhibitory Control and Attention Test 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

• Cognitive Function as determined by NIH List Sorting Working Memory 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 Sorting Working Memory 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

• Cognitive Function as determined by NIH Dimensional Change Card Sorting 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 Dimensional Change Card Sorting Test assesses cognitive flexibility and attention. Two target pictures are presented that vary along two dimensions (e.g., shape and color). Participants are asked to match a series of bivalent test pictures (e.g., yellow balls and blue trucks) to the target pictures, first according to one dimension (e.g., color) and then, after a number of trials, according to the other dimension (e.g., shape). "Switch" trials are also employed, in which the participant must change the dimension being matched. Scoring is based on a combination of accuracy and reaction time with a total range of possible scores 0-10 with higher scores indicating increased cognitive flexibility and attention.

  up to 1 day

• Cognitive Function as determined by NIH Pattern Comparison 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 (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

• Cognitive Function as determined by NIH Picture Sequence 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 (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

• Cognitive Function as determined by NIH Oral Reading Recognition 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 Reading Recognition Test assesses reading decoding skill and of crystallized abilities. The participant is asked to read and pronounce letters and words as accurately as possible. Scoring is based on the number of correct items with a possible score up to 2500. The higher the score, the better the crystallized abilities.

  up to 1 day

• 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

• Cerebral blood flow as determined by TCD

  CBF will be measured via TCD before (baseline) and after CO2 at 6 minutes; and before (baseline) and during exercise at 20 minutes.

  up to 1 day

Study Arms (1)

Enrolled, eligible

EXPERIMENTAL

Single arm for eligible subjects

Other: Hypercapnia; Device: Transcranial Doppler; Device: Cycle ergometer; Other: Cognitive Tests

Interventions

Hypercapnia OTHER

Eligible subjects will undergo transcranial Doppler assessment before and after hypercapnia exposure.

Also known as: CO2

Enrolled, eligible

Transcranial Doppler DEVICE

A transcranial Doppler ultrasound probe will be used to assess middle cerebral artery velocity to quantify cerebral blood flow at various time points throughout the study visit.

Also known as: TCD

Enrolled, eligible

Cycle ergometer DEVICE

A cycle ergometer will be used to acutely increase cerebral blood flow.

Also known as: Stationary bike

Enrolled, eligible

Cognitive Tests OTHER

A battery of cognitive tests will be completed by the subject.

Enrolled, eligible

Eligibility Criteria

• Age: 12 Years - 18 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Child (0-17), Adult (18-64)

You may qualify if:

• Age 12-18 years inclusive
• Typically developing and cognitively intact

You may not qualify if:

• Diabetes (≥126 mg dL-1 fasting glucose)
• Insulin treatment or sensitizing drugs
• Diagnosis of kidney, pulmonary, or heart disease (an asthma diagnosis that is not currently being treated with a daily controller medicine or asthma that requires medication use prior to exercise is not considered a pulmonary 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

Sponsors & Collaborators

• University of Wisconsin, Madison: lead

Study Sites (1)

University of Wisconsin-Madison

Madison, Wisconsin, 53706, United States

Location

MeSH Terms

Conditions

Insulin Resistance

Interventions

Ultrasonography, Doppler, Transcranial; Neuropsychological Tests

Condition Hierarchy (Ancestors)

Hyperinsulinism; Glucose Metabolism Disorders; Metabolic Diseases; Nutritional and Metabolic Diseases

Intervention Hierarchy (Ancestors)

Echoencephalography; Neuroradiography; Neuroimaging; Diagnostic Imaging; Diagnostic Techniques and Procedures; Diagnosis; Radiography; Ultrasonography; Ultrasonography, Doppler; Diagnostic Techniques, Neurological; Investigative Techniques; Psychological Tests; Behavioral Disciplines and Activities

Study Officials

• William Schrage, PhD

  University of Wisconsin, Madison

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: BASIC SCIENCE
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: November 4, 2019
• First Posted: November 7, 2019
• Study Start: February 28, 2020
• Primary Completion: November 19, 2021
• Study Completion: November 19, 2021
• Last Updated: October 3, 2024

Record last verified: 2024-10

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)