Acute Exercise on Brain Insulin Sensitivity

NCT05853913 | Completed DMC

• 1 other identifier: Pro2022001842
• Study Type: interventional
• Target: 16
• Locations: 1 country
• Sites: 4

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.

Conditions

Aging; Obesity; Insulin Resistance; Cognition; Cardiovascular Disease Risk

Keywords

Exercise

Outcome Measures

Primary Outcomes (1)

• Brain insulin sensitivity

  MRI arterial spin labeling, cerebral blood flow

  Change from baseline to exercise; about 1 week apart

Secondary Outcomes (5)

• Cognition

  Change from baseline to exercise; about 1 week apart

• Blood Glucose

  Change from baseline to exercise; about 1 week apart

• Blood Free Fatty Acids

  Change from baseline to exercise; about 1 week apart

• Carbohydrate Use

  Change from baseline to exercise; about 1 week apart

• Systolic and Diastolic Blood Pressure

  Change from baseline to exercise; about 1 week apart

Study Arms (2)

Rest

NO INTERVENTION

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

Exercise

EXPERIMENTAL

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

Behavioral: Exercise

Interventions

Exercise BEHAVIORAL

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

Exercise

Eligibility Criteria

• Age: 40 Years - 80 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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)

You may not qualify if:

• 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

Sponsors & Collaborators

• Rutgers, The State University of New Jersey: lead

Study Sites (4)

Institute for Food, Nutrition, and Health

New Brunswick, New Jersey, 08901, United States

Location

Robert Wood Johnson University Hospital Clinical Research Center

New Brunswick, New Jersey, 08901, United States

Location

Rutgers University Loree Gymnasium

New Brunswick, New Jersey, 08901, United States

Location

Center for Advanced Human Brain Imaging Research

Piscataway, New Jersey, 08854, United States

Location

MeSH Terms

Conditions

Obesity; Insulin Resistance; Motor Activity

Interventions

Exercise

Condition Hierarchy (Ancestors)

Overweight; Overnutrition; Nutrition Disorders; Nutritional and Metabolic Diseases; Body Weight; Signs and Symptoms; Pathological Conditions, Signs and Symptoms; Hyperinsulinism; Glucose Metabolism Disorders; Metabolic Diseases; Behavior

Intervention Hierarchy (Ancestors)

Motor Activity; Movement; Musculoskeletal Physiological Phenomena; Musculoskeletal and Neural Physiological Phenomena

Study Officials

• Steven K Malin, PhD

  Rutgers University - New Brunswick

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: CROSSOVER
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Associate Professor

Model Details: Individuals will perform both rest and exercise conditions.

Study Record Dates

• First Submitted: April 19, 2023
• First Posted: May 11, 2023
• Study Start: May 11, 2023
• Primary Completion: March 20, 2025
• Study Completion: March 25, 2025
• Last Updated: November 21, 2025

Record last verified: 2025-11

Data Sharing

• IPD Sharing: Will not share

Locations

US (4)