Acute Exercise on Brain Insulin Sensitivity

Obesity Clinical Trial

Official title:

Impact of Acute Exercise on Brain Insulin Sensitivity in Middle-aged to Older Adults

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05853913
• Other study ID #: Pro2022001842
• Status: Recruiting
• Phase: Phase 2/Phase 3
• 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
• 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

Related Conditions & MeSH terms

• Aging
• Cardiovascular Disease Risk
• Cardiovascular Diseases
• Cognition
• Insulin Resistance
• Obesity

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