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Acute Exercise on Brain Insulin Sensitivity

Primary Purpose

Aging, Obesity, Insulin Resistance

Status
Recruiting
Phase
Phase 2
Locations
United States
Study Type
Interventional
Intervention
Exercise
Sponsored by
Rutgers, The State University of New Jersey
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Aging focused on measuring Exercise

Eligibility Criteria

40 Years - 80 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • Institute for Food, Nutrition, and HealthRecruiting
  • Robert Wood Johnson University Hospital Clinical Research CenterRecruiting
  • Rutgers University Loree GymnasiumRecruiting
  • Center for Advanced Human Brain Imaging ResearchRecruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

No Intervention

Experimental

Arm Label

Rest

Exercise

Arm Description

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

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

Outcomes

Primary Outcome Measures

Brain insulin sensitivity
MRI arterial spin labeling, cerebral blood flow

Secondary Outcome Measures

Cognition
NIH Toolbox Cognitive Battery
Blood Glucose
Blood draw via oxidase method
Blood Free Fatty Acids
Blood draw via colorimetric assays
Carbohydrate Use
Indirect Calorimetry
Systolic and Diastolic Blood Pressure
Cuff around arm

Full Information

First Posted
April 19, 2023
Last Updated
May 11, 2023
Sponsor
Rutgers, The State University of New Jersey
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1. Study Identification

Unique Protocol Identification Number
NCT05853913
Brief Title
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

2. Study Status

Record Verification Date
May 2023
Overall Recruitment Status
Recruiting
Study Start Date
May 11, 2023 (Actual)
Primary Completion Date
April 30, 2025 (Anticipated)
Study Completion Date
December 30, 2025 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Rutgers, The State University of New Jersey

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Aging, Obesity, Insulin Resistance, Cognition, Cardiovascular Disease Risk
Keywords
Exercise

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 2, Phase 3
Interventional Study Model
Crossover Assignment
Model Description
Individuals will perform both rest and exercise conditions.
Masking
None (Open Label)
Allocation
Randomized
Enrollment
40 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Rest
Arm Type
No Intervention
Arm Description
Individuals will rest for about 1 hour in the seated position to mimic time exercising.
Arm Title
Exercise
Arm Type
Experimental
Arm Description
Individuals will exercise for at medium to hard intensity for 1 hour.
Intervention Type
Behavioral
Intervention Name(s)
Exercise
Intervention Description
Exercise will be walking/jogging at a medium to hard intensity for 1 hour.
Primary Outcome Measure Information:
Title
Brain insulin sensitivity
Description
MRI arterial spin labeling, cerebral blood flow
Time Frame
Change from baseline to exercise; about 1 week apart
Secondary Outcome Measure Information:
Title
Cognition
Description
NIH Toolbox Cognitive Battery
Time Frame
Change from baseline to exercise; about 1 week apart
Title
Blood Glucose
Description
Blood draw via oxidase method
Time Frame
Change from baseline to exercise; about 1 week apart
Title
Blood Free Fatty Acids
Description
Blood draw via colorimetric assays
Time Frame
Change from baseline to exercise; about 1 week apart
Title
Carbohydrate Use
Description
Indirect Calorimetry
Time Frame
Change from baseline to exercise; about 1 week apart
Title
Systolic and Diastolic Blood Pressure
Description
Cuff around arm
Time Frame
Change from baseline to exercise; about 1 week apart

10. Eligibility

Sex
All
Minimum Age & Unit of Time
40 Years
Maximum Age & Unit of Time
80 Years
Accepts Healthy Volunteers
No
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
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Steven K Malin, PhD
Phone
848-932-7054
Email
steven.malin@rutgers.edu
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Steven K Malin, PhD
Organizational Affiliation
Rutgers University - New Brunswick
Official's Role
Principal Investigator
Facility Information:
Facility Name
Institute for Food, Nutrition, and Health
City
New Brunswick
State/Province
New Jersey
ZIP/Postal Code
08901
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Sue Shapses, PhD
Phone
848-932-9403
Email
shapses@rutgers.edu
Facility Name
Robert Wood Johnson University Hospital Clinical Research Center
City
New Brunswick
State/Province
New Jersey
ZIP/Postal Code
08901
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Deborah McCloskey
Phone
732-235-5965
Email
mcclosda@rwjms.rutgers.edu
Facility Name
Rutgers University Loree Gymnasium
City
New Brunswick
State/Province
New Jersey
ZIP/Postal Code
08901
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Steven K Malin, PhD
Phone
848-932-7540
Email
steven.malin@rutgers.edu
Facility Name
Center for Advanced Human Brain Imaging Research
City
Piscataway
State/Province
New Jersey
ZIP/Postal Code
08854
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
David Zald, PhD
Phone
732-235-7211
Email
dz268@rbhs.rutgers.edu

12. IPD Sharing Statement

Plan to Share IPD
No

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Acute Exercise on Brain Insulin Sensitivity

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