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Exercise in Adolescents With Insulin Resistance

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT04154865
Recruitment Status : Suspended (Due to COVID-19)
First Posted : November 7, 2019
Last Update Posted : August 27, 2020
Sponsor:
Information provided by (Responsible Party):
University of Wisconsin, Madison

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.

Condition or disease Intervention/treatment Phase
Insulin Resistance Other: Hypercapnia Device: Transcranial Doppler Device: Cycle ergometer Other: Cognitive Tests Not Applicable

Detailed Description:
One in five American adolescents are obese, and many of these patients exhibit some level of insulin resistance (IR). IR is associated with cerebrovascular disease, reduced memory, attention, and cognition, but how IR contributes to these in the course of adolescent brain development is unclear. The goal of this proposal is to investigate the extent and by which IR drives reductions in neurocognitive function and cerebral blood flow (CBF) in adolescents at elevated risk for poor brain and cerebrovascular health. The overall goal of this research program is to investigate IR-related changes in neurocognitive and vascular function. The investigators propose to study adolescents across a spectrum of IR, from healthy to pre-diabetic, without confounding effects of age or diabetes- before the negative effects of IR can exert their full negative impact. The general hypothesis is that cognitive and vascular function is impaired due to dysfunctional brain blood vessel responses.

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 20 participants
Allocation: N/A
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Basic Science
Official Title: Exercise in Adolescents With Insulin Resistance: A Path to Improved Brain Health?
Actual Study Start Date : February 28, 2020
Estimated Primary Completion Date : July 2021
Estimated Study Completion Date : July 2021

Arm Intervention/treatment
Experimental: Enrolled, eligible
Single arm for eligible subjects
Other: Hypercapnia
Eligible subjects will undergo transcranial Doppler assessment before and after hypercapnia exposure.
Other Name: CO2

Device: Transcranial Doppler
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.
Other Name: TCD

Device: Cycle ergometer
A cycle ergometer will be used to acutely increase cerebral blood flow.
Other Name: Stationary bike

Other: Cognitive Tests
A battery of cognitive tests will be completed by the subject.




Primary Outcome Measures :
  1. Cognitive Function as determined by NIH Toolbox Picture Vocabulary Test [ Time Frame: up to 1 day ]

    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.


  2. Cognitive Function as determined by NIH Flanker Inhibitory Control and Attention Test [ Time Frame: up to 1 day ]

    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.


  3. Cognitive Function as determined by NIH List Sorting Working Memory Test [ Time Frame: up to 1 day ]

    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.


  4. Cognitive Function as determined by NIH Dimensional Change Card Sorting Test [ Time Frame: up to 1 day ]

    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.


  5. Cognitive Function as determined by NIH Pattern Comparison Test [ Time Frame: up to 1 day ]

    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.


  6. Cognitive Function as determined by NIH Picture Sequence Test [ Time Frame: up to 1 day ]

    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.


  7. Cognitive Function as determined by NIH Oral Reading Recognition Test [ Time Frame: up to 1 day ]

    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.


  8. Cognitive Function as determined by PedsQL - (Child 8-12/Teen 13-18) [ Time Frame: up to 1 day ]

    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.


  9. Cerebral blood flow as determined by TCD [ Time Frame: up to 1 day ]
    CBF will be measured via TCD before (baseline) and after CO2 at 6 minutes; and before (baseline) and during exercise at 20 minutes.



Information from the National Library of Medicine

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Ages Eligible for Study:   12 Years to 18 Years   (Child, Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Criteria

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04154865


Locations
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United States, Wisconsin
University of Wisconsin-Madison
Madison, Wisconsin, United States, 53706
Sponsors and Collaborators
University of Wisconsin, Madison
Investigators
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Principal Investigator: William Schrage, PhD University of Wisconsin, Madison
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Responsible Party: University of Wisconsin, Madison
ClinicalTrials.gov Identifier: NCT04154865    
Other Study ID Numbers: 2019-0838
2019-0838 ( Other Identifier: Institutional Review Board )
A176000 ( Other Identifier: UW Madison )
EDUC/KINESIOLOGY ( Other Identifier: UW Madison )
Protocol Version 10/18/2019 ( Other Identifier: UW Madison )
First Posted: November 7, 2019    Key Record Dates
Last Update Posted: August 27, 2020
Last Verified: March 2020
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
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Insulin Resistance
Hyperinsulinism
Glucose Metabolism Disorders
Metabolic Diseases