Clinical trial NCT05853913: Acute Exercise on Brain Insulin Sensitivity
Official title: Impact of Acute Exercise on Brain Insulin Sensitivity in Middle-aged to Older Adults
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: PHASE2
PHASE3
Conditions: Aging
Obesity
Insulin Resistance
Cognition
Cardiovascular Disease Risk
Keywords: Exercise
Lead sponsor: Rutgers, The State University of New Jersey
Sponsor class: OTHER
First posted: 2023-05-11
Enrollment: 40
Sex: ALL
Minimum age (years): 40
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Intervention model description: Individuals will perform both rest and exercise conditions.
Primary purpose: TREATMENT

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.

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.

Eligibility criteria: 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

Primary outcomes:
measure: Brain insulin sensitivity
timeFrame: Change from baseline to exercise; about 1 week apart
Secondary outcomes:
measure: Cognition
timeFrame: Change from baseline to exercise; about 1 week apart
measure: Blood Glucose
timeFrame: Change from baseline to exercise; about 1 week apart
measure: Blood Free Fatty Acids
timeFrame: Change from baseline to exercise; about 1 week apart
measure: Carbohydrate Use
timeFrame: Change from baseline to exercise; about 1 week apart
measure: Systolic and Diastolic Blood Pressure
timeFrame: Change from baseline to exercise; about 1 week apart
Other outcomes:
Locations:
city: New Brunswick
country: United States
facility: Institute for Food, Nutrition, and Health
state: New Jersey
city: New Brunswick
country: United States
facility: Robert Wood Johnson University Hospital Clinical Research Center
state: New Jersey
city: New Brunswick
country: United States
facility: Rutgers University Loree Gymnasium
state: New Jersey
city: Piscataway
country: United States
facility: Center for Advanced Human Brain Imaging Research
state: New Jersey
Study officials:
affiliation: Rutgers University - New Brunswick
name: Steven K Malin, PhD
role: PRINCIPAL_INVESTIGATOR
References: