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Acute Exercise on Brain Insulin Sensitivity

Sponsor
Rutgers, The State University of New Jersey (Other)
Overall Status
Recruiting
CT.gov ID
NCT05853913
Collaborator
(none)
40
Enrollment
4
Locations
2
Arms
31.7
Anticipated Duration (Months)
10
Patients Per Site
0.3
Patients Per Site Per Month

Study Details

Study Description

Brief Summary

Dementia is a leading cause of death in the United States among aging adults. Brain insulin resistance has emerged as a pathologic factor affecting memory, executive function as well as systemic glucose control. Regular aerobic exercise decreases Alzheimer's Disease (AD) risk, in part, through changes in brain structure and function. However, there is limited data available on how exercise impacts brain insulin resistance in aging. This study will test the effect of acute exercise on brain insulin sensitivity in middle-aged to older adults. The study will also examine cognition and cardiometabolic health in relation to brain insulin sensitivity.

Condition or Disease Intervention/Treatment Phase
  • Behavioral: Exercise
 Phase 2/Phase 3

Detailed Description

Obesity, hypertension, high blood glucose (e.g. prediabetes/type 2 diabetes), and physical inactivity is thought to worsen brain insulin resistance and reduce cerebral blood flow. This suggests lifestyle approaches may be necessary to counteract declines in brain health. Regular aerobic exercise decreases Alzheimer's Disease (AD) risk, in part, through changes in brain structure and function. Moreover, exercise-related structural changes in the brain, namely increased hippocampal volume, is linked to improved memory. However, there is limited data available on how exercise impacts brain insulin resistance in aging. It is also unclear if one bout of exercise may help improve brain insulin responses to insulin before fitness gains or weight loss in people at risk for dementia, type 2 diabetes and cardiovascular disease. Because single bouts of exercise are established to improve metabolic and vascular insulin sensitivity in people with obesity, the investigators anticipate exercise to raise brain insulin sensitivity in relation to cognition and cardiometabolic health.

Study Design

Study Type:
Interventional
Anticipated Enrollment :
40 participants
Allocation:
Randomized
Intervention Model:
Crossover Assignment
Intervention Model Description:
Individuals will perform both rest and exercise conditions.Individuals will perform both rest and exercise conditions.
Masking:
None (Open Label)
Primary Purpose:
Treatment
Official Title:
Impact of Acute Exercise on Brain Insulin Sensitivity in Middle-aged to Older Adults
Actual Study Start Date :
May 11, 2023
Anticipated Primary Completion Date :
Apr 30, 2025
Anticipated Study Completion Date :
Dec 30, 2025

Arms and Interventions

Arm Intervention/Treatment
No Intervention: Rest

Individuals will rest for about 1 hour in the seated position to mimic time exercising.
Experimental: Exercise

Individuals will exercise for at medium to hard intensity for 1 hour.

Behavioral: Exercise
Exercise will be walking/jogging at a medium to hard intensity for 1 hour.

Outcome Measures

Primary Outcome Measures

  1. Brain insulin sensitivity [Change from baseline to exercise; about 1 week apart]

    MRI arterial spin labeling, cerebral blood flow

Secondary Outcome Measures

  1. Cognition [Change from baseline to exercise; about 1 week apart]

    NIH Toolbox Cognitive Battery

  2. Blood Glucose [Change from baseline to exercise; about 1 week apart]

    Blood draw via oxidase method

  3. Blood Free Fatty Acids [Change from baseline to exercise; about 1 week apart]

    Blood draw via colorimetric assays

  4. Carbohydrate Use [Change from baseline to exercise; about 1 week apart]

    Indirect Calorimetry

  5. Systolic and Diastolic Blood Pressure [Change from baseline to exercise; about 1 week apart]

    Cuff around arm

Eligibility Criteria

Criteria

Ages Eligible for Study:
40 Years to 80 Years
Sexes Eligible for Study:
All
Accepts Healthy Volunteers:
No
Inclusion Criteria:

  • Male or female >40 and <80 years old.

  • Has a body mass index >25 and <45 kg/m2.

  • Physical Activity (<150 min of moderate/high intensity exercise per week)

Exclusion Criteria:

  • Subjects who have not been weight stable (>2 kg weight change in past 3 months)

  • Subjects who are smokers or who have quit smoking <1 years ago

  • Subjects with abnormal estimated glomerular filtration rate (eGFR).

  • Hypertriglyceridemic (>400 mg/dl) and hypercholesterolemic (>260 mg/dl) subjects

  • Hypertensive (>160/100 mmHg)

  • Subjects with a history of significant metabolic, cardiac, congestive heart failure, cerebrovascular, hematological, pulmonary, gastrointestinal, liver, renal, or endocrine disease or cancer that in the investigator's opinion would interfere with or alter the outcome measures or impact subject safety.

  • Pregnant (as evidenced by positive urine pregnancy test) or nursing women

  • Subjects with contraindications to participation in an exercise

  • Current Pregnancy

  • Currently taking active weight suppression medication (e.g. phentermine, orlistat, lorcaserin, naltrexone-bupropion in combination, liraglutide, benzphetamine, diethylpropion, phendimetrazine)

  • Subjects currently taking medications that affect heart rate and rhythm (i.e. Ca++ channel blockers, nitrates, alpha- or beta-blockers).

  • Known contraindications for MRI imaging

Contacts and Locations

Locations

Site City State Country Postal Code
1 Institute for Food, Nutrition, and Health New Brunswick New Jersey United States 08901
2 Robert Wood Johnson University Hospital Clinical Research Center New Brunswick New Jersey United States 08901
3 Rutgers University Loree Gymnasium New Brunswick New Jersey United States 08901
4 Center for Advanced Human Brain Imaging Research Piscataway New Jersey United States 08854

Sponsors and Collaborators

  • Rutgers, The State University of New Jersey

Investigators

  • Principal Investigator: Steven K Malin, PhD, Rutgers University - New Brunswick

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.
Responsible Party:
Steven K Malin, PhD, Associate Professor, Rutgers, The State University of New Jersey
ClinicalTrials.gov Identifier:
NCT05853913
Other Study ID Numbers:
  • Pro2022001842
First Posted:
May 11, 2023
Last Update Posted:
May 15, 2023
Last Verified:
May 1, 2023
Individual Participant Data (IPD) Sharing Statement:
No
Plan to Share IPD:
No
Studies a U.S. FDA-regulated Drug Product:
No
Studies a U.S. FDA-regulated Device Product:
No
Keywords provided by Steven K Malin, PhD, Associate Professor, Rutgers, The State University of New Jersey
Exercise
Additional relevant MeSH terms:
Cardiovascular Diseases
Insulin Resistance

Study Results

No Results Posted as of May 15, 2023