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Clinical Trial Details — Status: Recruiting

Administrative data

NCT number NCT05853913
Other study ID # Pro2022001842
Secondary ID
Status Recruiting
Phase Phase 2/Phase 3
First received
Last updated
Start date May 11, 2023
Est. completion date December 30, 2025

Study information

Verified date May 2023
Source Rutgers, The State University of New Jersey
Contact Steven K Malin, PhD
Phone 848-932-7054
Email steven.malin@rutgers.edu
Is FDA regulated No
Health authority
Study type Interventional

Clinical 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. 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.


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.


Recruitment information / eligibility

Status Recruiting
Enrollment 40
Est. completion date December 30, 2025
Est. primary completion date April 30, 2025
Accepts healthy volunteers No
Gender All
Age group 40 Years to 80 Years
Eligibility 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

Study Design


Intervention

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

Locations

Country Name City State
United States Institute for Food, Nutrition, and Health New Brunswick New Jersey
United States Robert Wood Johnson University Hospital Clinical Research Center New Brunswick New Jersey
United States Rutgers University Loree Gymnasium New Brunswick New Jersey
United States Center for Advanced Human Brain Imaging Research Piscataway New Jersey

Sponsors (1)

Lead Sponsor Collaborator
Rutgers, The State University of New Jersey

Country where clinical trial is conducted

United States, 

Outcome

Type Measure Description Time frame Safety issue
Primary Brain insulin sensitivity MRI arterial spin labeling, cerebral blood flow Change from baseline to exercise; about 1 week apart
Secondary Cognition NIH Toolbox Cognitive Battery Change from baseline to exercise; about 1 week apart
Secondary Blood Glucose Blood draw via oxidase method Change from baseline to exercise; about 1 week apart
Secondary Blood Free Fatty Acids Blood draw via colorimetric assays Change from baseline to exercise; about 1 week apart
Secondary Carbohydrate Use Indirect Calorimetry Change from baseline to exercise; about 1 week apart
Secondary Systolic and Diastolic Blood Pressure Cuff around arm Change from baseline to exercise; about 1 week apart
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