AgingNCT05853913
Acute Exercise on Brain Insulin Sensitivity
A study testing Exercise in people with Aging and Obesity, run by Rutgers, The State University of New Jersey at 4 sites in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 40 to 80 years
- Conditions the study is for
- Aging, Obesity, Insulin Resistance
- What is being tested?
- Exercise
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 16 participants
- Where
- 4 sitesUnited States
- Study dates
- 11 May 2023to 25 Mar 2025
- 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 40 to 80 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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)
Who cannot join
- 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.
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- 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
Trial locations and contacts
4 sites in 1 country.
United States4 sites
Institute for Food, Nutrition, and Health
New Brunswick, New Jersey, 08901
Robert Wood Johnson University Hospital Clinical Research Center
New Brunswick, New Jersey, 08901
Rutgers University Loree Gymnasium
New Brunswick, New Jersey, 08901
Center for Advanced Human Brain Imaging Research
Piscataway, New Jersey, 08854
About this study
Official title: Impact of Acute Exercise on Brain Insulin Sensitivity in Middle-aged to Older Adults
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.
Read the 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.
- Conditions
- Aging, Obesity, Insulin Resistance, Cognition, Cardiovascular Disease Risk
- Being tested
- Exercise
- Keywords
- Exercise
- Medical subject headings
- Obesity, Insulin Resistance, Motor Activity
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
ExerciseBehavioural
Exercise will be walking/jogging at a medium to hard intensity for 1 hour.
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: Behavioral: Exercise |
What is being measured
The primary outcome is the main question the study is designed to answer.
Brain insulin sensitivity
MRI arterial spin labeling, cerebral blood flow
Measured: Change from baseline to exercise; about 1 week apart
Secondary outcomes (5)
Cognition
NIH Toolbox Cognitive Battery
Measured: Change from baseline to exercise; about 1 week apart
Blood Glucose
Blood draw via oxidase method
Measured: Change from baseline to exercise; about 1 week apart
Blood Free Fatty Acids
Blood draw via colorimetric assays
Measured: Change from baseline to exercise; about 1 week apart
Carbohydrate Use
Indirect Calorimetry
Measured: Change from baseline to exercise; about 1 week apart
Systolic and Diastolic Blood Pressure
Cuff around arm
Measured: Change from baseline to exercise; about 1 week apart
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted11 May 2023
- Study start11 May 2023
- Primary completion20 Mar 2025
- Study completion25 Mar 2025
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for AgingStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
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
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Model description
- Individuals will perform both rest and exercise conditions.
- Masking
- None (open label)
- Enrolment
- 16 participants (actual)
Sponsor and investigators
- Lead sponsor
- Rutgers, The State University of New Jersey
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Steven K Malin, PhD, Rutgers, The State University of New Jersey
- Investigators
- Steven K Malin, PhD, Principal investigator, Rutgers University - New Brunswick
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05853913
- Sponsor's protocol ID
- Pro2022001842
- Status last verified
- Nov 2025
- First submitted
- 19 Apr 2023
- Last updated
- 21 Nov 2025
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Malin SK, Zald DH, Battillo DJ. Acute exercise reduces intranasal insulin-mediated elevations in blood pressure in aging adults with cardiometabolic risk. Am J Physiol Regul Integr Comp Physiol. 2026 Aug 1;331(2):R147-R154. doi: 10.1152/ajpregu.00119.2026. Epub 2026 Jun 15.
PubMed 42295834Malin SK, Battillo DJ, Beeri MS, Mustapic M, Kapogiannis D. A Single Bout of Aerobic Exercise Increases Neuronal Extracellular Vesicle-Derived Insulin Signaling Biomarkers in Adults With Cardiometabolic Risk. Compr Physiol. 2026 Apr;16(2):e70131. doi: 10.1002/cph4.70131.
PubMed 41876945
Study at a glance
From the registry record, last updated by the sponsor on 21 Nov 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Impact of Acute Exercise on Brain Insulin Sensitivity in Middle-aged to Older Adults
- ClinicalTrials.gov ID
- NCT05853913
- Acronym / sponsor ID
- Pro2022001842
- Conditions
- Aging, Obesity, Insulin Resistance, Cognition, Cardiovascular Disease Risk
- Keywords
- Exercise
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 16 participants (actual)
- Lead sponsor
- Rutgers, The State University of New JerseyUniversity, hospital or other
- Study start
- 11 May 2023 (actual)
- Primary completion
- 20 Mar 2025 (actual)
- Study completion
- 25 Mar 2025 (actual)
- First posted
- 11 May 2023 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- Number of arms
- 2
- Model description
- Individuals will perform both rest and exercise conditions.
| Arm | Type | Receives |
|---|---|---|
| Rest | No intervention | –Individuals will rest for about 1 hour in the seated position to mimic time exercising. |
| Exercise | Experimental | Behavioral: ExerciseIndividuals will exercise for at medium to hard intensity for 1 hour. |
Who may qualify
- Ages
- 40 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- 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)
Key exclusion criteria (12 listed)
- 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)
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| ExerciseExercise will be walking/jogging at a medium to hard intensity for 1 hour. | Behavioural | Exercise |
Primary outcome
Brain insulin sensitivity
Time frame: Change from baseline to exercise; about 1 week apart
MRI arterial spin labeling, cerebral blood flow
5 secondary outcomes
Cognition
Time frame: Change from baseline to exercise; about 1 week apart
Blood Glucose
Time frame: Change from baseline to exercise; about 1 week apart
Blood Free Fatty Acids
Time frame: Change from baseline to exercise; about 1 week apart
Carbohydrate Use
Time frame: Change from baseline to exercise; about 1 week apart
Systolic and Diastolic Blood Pressure
Time frame: Change from baseline to exercise; about 1 week apart
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 21 Nov 2025.
- Derived from this study: PubMed 42295834Malin SK, Zald DH, Battillo DJ. Acute exercise reduces intranasal insulin-mediated elevations in blood pressure in aging adults with cardiometabolic risk. Am J Physiol Regul Integr Comp Physiol. 2026 Aug 1;331(2):R147-R154. doi: 10.1152/ajpregu.00119.2026. Epub 2026 Jun 15.
- Derived from this study: PubMed 41876945Malin SK, Battillo DJ, Beeri MS, Mustapic M, Kapogiannis D. A Single Bout of Aerobic Exercise Increases Neuronal Extracellular Vesicle-Derived Insulin Signaling Biomarkers in Adults With Cardiometabolic Risk. Compr Physiol. 2026 Apr;16(2):e70131. doi: 10.1002/cph4.70131.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Steven K Malin, PhD principal investigator
Rutgers University - New Brunswick
4 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Exercise in people with Aging and Obesity, run by Rutgers, The State University of New Jersey at 4 sites 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 3 inclusion and 12 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: finished, as of the sponsor's last update on 21 Nov 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 4 sites 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 is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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?
Brain insulin sensitivity (time frame: Change from baseline to exercise; about 1 week apart). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT05853913, which also lists 2 linked publications.
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 21 Nov 2025.