Back to resultsHyperglycemia, Exercise, and Endothelial Function
Primary Purpose
Endothelial Function, Hyperglycemia
Status
Completed
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
GLU+EX
GLU
Sponsored by
About this trial
This is an interventional basic science trial for Endothelial Function focused on measuring exercise, glucose, vascular function
Eligibility Criteria
Inclusion Criteria:
- Healthy young men 18-35 years of age.
Exclusion Criteria:
- Hypertension,
- Hyperlipidemia,
- Smoking,
- Heart disease,
- Chest pain upon exertion,
- Previous heart surgeries or history of arrhythmias,
- Diabetes,
- Obesity (body mass index ≥30kg/m2),
- Kidney disease,
- Pulmonary disease,
- Autonomic disorders,
- Individuals whom engage in structured exercise (≥30min, ≥2d/wk),
- Current use of medications which influence outcome measures
Sites / Locations
- Medical Education Building
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Active Comparator
Arm Label
GLU+EX
GLU
Arm Description
Subjects will consume a 75g glucose beverage three times daily for seven days while participating in five structured aerobic exercise sessions throughout the experimental protocol.
Subjects will consume a 75g glucose beverage three times daily for seven days without participating in structured aerobic exercise.
Outcomes
Primary Outcome Measures
Change in Vascular Endothelial Function
Brachial artery flow-mediated dilation (%), measured via Doppler ultrasound, will be assessed before and after the intervention.
Secondary Outcome Measures
Central Blood Pressure
Aortic blood pressure will be derived from radial artery pressure wave measurements (via applanation tonometry) during resting conditions.
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT03651713
Brief Title
Hyperglycemia, Exercise, and Endothelial Function
Official Title
Effect of Short-Term Glucose Loading on Vascular Function
Study Type
Interventional
2. Study Status
Record Verification Date
March 2020
Overall Recruitment Status
Completed
Study Start Date
October 15, 2018 (Actual)
Primary Completion Date
October 21, 2019 (Actual)
Study Completion Date
October 21, 2019 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
University of Iowa
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No
5. Study Description
Brief Summary
The main purpose of this study is to determine if exercise preserves vascular function during hyperglycemia. All subjects will consume a sugary beverage three times daily for seven days. Subjects will be randomly assigned to either the glucose with (GLU+EX) or without (GLU) structured exercise group.
Detailed Description
Acute (oral glucose tolerance test) and chronic (type 2 diabetes) hyperglycemia are associated with impaired endothelial function. Both a single bout of exercise and chronic exercise training are associated with improvements in vascular endothelial function. It remains unknown if exercise can preserve vascular endothelial function during hyperglycemia.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Endothelial Function, Hyperglycemia
Keywords
exercise, glucose, vascular function
7. Study Design
Primary Purpose
Basic Science
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Model Description
Randomized
Masking
None (Open Label)
Allocation
Randomized
Enrollment
32 (Actual)
8. Arms, Groups, and Interventions
Arm Title
GLU+EX
Arm Type
Experimental
Arm Description
Subjects will consume a 75g glucose beverage three times daily for seven days while participating in five structured aerobic exercise sessions throughout the experimental protocol.
Arm Title
GLU
Arm Type
Active Comparator
Arm Description
Subjects will consume a 75g glucose beverage three times daily for seven days without participating in structured aerobic exercise.
Intervention Type
Behavioral
Intervention Name(s)
GLU+EX
Intervention Description
Subjects will complete 45 minutes of recumbent cycling at 60-65% of age-predicted maximal heart rate five times over seven days while ingesting a 75g glucose beverage three times daily.
Intervention Type
Dietary Supplement
Intervention Name(s)
GLU
Intervention Description
Subjects will consume a 75g glucose beverage three times daily over a seven-day period.
Primary Outcome Measure Information:
Title
Change in Vascular Endothelial Function
Description
Brachial artery flow-mediated dilation (%), measured via Doppler ultrasound, will be assessed before and after the intervention.
Time Frame
Before and after the seven-day intervention in both groups.
Secondary Outcome Measure Information:
Title
Central Blood Pressure
Description
Aortic blood pressure will be derived from radial artery pressure wave measurements (via applanation tonometry) during resting conditions.
Time Frame
Before and after the seven-day intervention in both groups.
Other Pre-specified Outcome Measures:
Title
Physical Activity
Description
Steps per day will be recorded via accelerometry throughout the intervention in both groups.
Time Frame
Continuously throughout the seven-day intervention.
Title
Caloric Consumption
Description
Subjects will record their dietary intake throughout the intervention.
Time Frame
Continuously throughout the seven-day intervention.
10. Eligibility
Sex
Male
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
35 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
Inclusion Criteria:
- Healthy young men 18-35 years of age.
Exclusion Criteria:
Hypertension,
Hyperlipidemia,
Smoking,
Heart disease,
Chest pain upon exertion,
Previous heart surgeries or history of arrhythmias,
Diabetes,
Obesity (body mass index ≥30kg/m2),
Kidney disease,
Pulmonary disease,
Autonomic disorders,
Individuals whom engage in structured exercise (≥30min, ≥2d/wk),
Current use of medications which influence outcome measures
Facility Information:
Facility Name
Medical Education Building
City
Iowa City
State/Province
Iowa
ZIP/Postal Code
52242
Country
United States
12. IPD Sharing Statement
Plan to Share IPD
No
Learn more about this trial
Hyperglycemia, Exercise, and Endothelial Function
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