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Insulin ResistanceNCT04154865

Exercise in Adolescents With Insulin Resistance

A study testing Hypercapnia, Transcranial Doppler and Cycle ergometer in people with Insulin Resistance, run by University of Wisconsin, Madison at 1 site in United States.

Terminated

Stopped early. The study ended before it was planned to and will not resume.

Official record
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Trial 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… Read more about this study

Who is it for?
Ages 12 to 18 yearsHealthy volunteers can take part
Conditions the study is for
Insulin Resistance
What is being tested?
Hypercapnia, Transcranial Doppler and Cycle ergometer
Type of treatment
Medical device
Could I receive a placebo?
No, everyone receives an active treatment
How many people
15 participants
Where
1 siteUnited States
Study dates
28 Feb 2020to 19 Nov 2021
Phase
Interventional
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 12 to 18 years
  • All sexes
  • Healthy volunteers accepted
  • Child, Adult

Who may be able to join

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

Who cannot join

  • 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)
Show all 11Show fewer
  • 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

Trial locations and contacts

1 site in 1 country.

United States1 site
  • University of Wisconsin-Madison

    Madison, Wisconsin, 53706

Other trials in United States

About this study

Official title: Exercise in Adolescents With Insulin Resistance: A Path to Improved Brain Health?

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.

Read the detailed description

Insulin resistance (IR), a hallmark of metabolic syndrome and diabetes, is strongly linked to numerous health disorders, including cardiovascular and cerebrovascular disease. In adults, data indicate IR negatively impacts brain structure and function, such as decreased regional brain volumes, increased white matter hyperintensities, and poorer memory and attention, all of which are hallmarks of Alzheimer's disease and related dementias. In parallel with data from adults, emerging data from adolescents with IR suggest similar brain structural and functional changes. Importantly, these changes occur during a critical period for proper brain development and maturation, thus having a potentially fateful impact on these young brains as they mature into adulthood.

In addition to brain structural and cognitive changes, IR is also associated with lower cerebral blood flow (CBF), which is linked to neurocognitive problems in adults. The consequences of IR on cerebrovascular dysfunction- and its interaction with neurocognition- in adolescents remain largely unexplored. Therefore, impaired vascular function may hold tremendous influence over brain health in adolescents at a vital period in brain development.

Exercise is a key factor in treating IR from a metabolic perspective, and acts as the only effective intervention known to combat dementia-related diseases in adults. Furthermore, exercise can acutely increase cognitive abilities and CBF, and adults with higher aerobic fitness demonstrate greater CBF, and CBF is increased following exercise training. With this as background, a few questions emerge regarding adolescents with IR: is there a dose-response relationship between IR severity and cognitive function? Can exercise improve cognition and impact brain health? What is the role of vascular function in cognition on potential exercise-induced improvements?

The long-term goal of this research program is to determine the influence of IR, physical activity, and their interaction on brain development in adolescents by interrogating the relationships between neurocognition, brain structure, and underlying mechanisms. The primary goal of the current pilot project is to quantify neurocognitive function in relation to the severity of IR and use acute exercise as a tool to improve function. The central hypothesis is that as IR worsens: 1) subtle neurocognitive abnormalities worsen, 2) exercise-mediated improvements in neurocognitive function are blunted, due in part to 3) reduced CBF responses.

Participants will be recruited primarily from pediatric and pediatric endocrinology clinics via our collaborator, Dr. Aaron Carrel, and his staff in UWHC Pediatric Endocrinology. Additionally, participants will be recruited from the greater Madison, WI community.

Being tested
Hypercapnia, Transcranial Doppler, Cycle ergometer, Cognitive Tests
Medical subject headings
Insulin Resistance

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • HypercapniaOther

    Also called CO2

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

  • Transcranial DopplerDevice

    Also called TCD

    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.

  • Cycle ergometerDevice

    Also called Stationary bike

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

  • Cognitive TestsOther

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

Study groups in NCT04154865
Study groupRoleWhat they receive
Enrolled, eligibleExperimentalSingle arm for eligible subjects
Receives: Other: Hypercapnia; Device: Transcranial Doppler; Device: Cycle ergometer; Other: Cognitive Tests

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. 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.

    Measured: up to 1 day

  2. 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.

    Measured: up to 1 day

  3. 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.

    Measured: up to 1 day

  4. 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.

    Measured: up to 1 day

  5. 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.

    Measured: up to 1 day

  6. 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.

    Measured: up to 1 day

  7. 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.

    Measured: up to 1 day

  8. 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.

    Measured: up to 1 day

  9. 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.

    Measured: up to 1 day

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted7 Nov 2019
  2. Study start28 Feb 2020
  3. Primary completion19 Nov 2021
  4. Study completion19 Nov 2021

Why it stopped: Equipment failure

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase N/A
Primary purpose
Basic science
Allocation
Not applicable
Intervention model
Single group
Masking
None (open label)
Enrolment
15 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT04154865
Sponsor's protocol ID
2019-0838
Other IDs
2019-0838, A176000, EDUC/KINESIOLOGY, Protocol Version 2/10/2023
Status last verified
Oct 2024
First submitted
4 Nov 2019
Last updated
3 Oct 2024
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
No

Questions about this trial

What is this clinical trial studying?

A study testing Hypercapnia, Transcranial Doppler and Cycle ergometer in people with Insulin Resistance, run by University of Wisconsin, Madison at 1 site in United States.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 2 inclusion and 11 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: stopped early, as of the sponsor's last update on 3 Oct 2024. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

The study was stopped early (reason given: Equipment failure). Results are not available in the source record.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Cognitive Function as determined by NIH Toolbox Picture Vocabulary Test (time frame: up to 1 day). The study lists 9 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 3 Oct 2024.

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