Hyperglycemia, Exercise, and Endothelial Function
Effect of Short-Term Glucose Loading on Vascular Function
1 other identifier
interventional
32
1 country
1
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P25-P50 for not_applicable
Started Oct 2018
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
August 22, 2018
CompletedFirst Posted
Study publicly available on registry
August 29, 2018
CompletedStudy Start
First participant enrolled
October 15, 2018
CompletedPrimary Completion
Last participant's last visit for primary outcome
October 21, 2019
CompletedStudy Completion
Last participant's last visit for all outcomes
October 21, 2019
CompletedMarch 24, 2020
March 1, 2020
1 year
August 22, 2018
March 23, 2020
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Change in Vascular Endothelial Function
Brachial artery flow-mediated dilation (%), measured via Doppler ultrasound, will be assessed before and after the intervention.
Before and after the seven-day intervention in both groups.
Secondary Outcomes (1)
Central Blood Pressure
Before and after the seven-day intervention in both groups.
Other Outcomes (2)
Physical Activity
Continuously throughout the seven-day intervention.
Caloric Consumption
Continuously throughout the seven-day intervention.
Study Arms (2)
GLU+EX
EXPERIMENTALSubjects will consume a 75g glucose beverage three times daily for seven days while participating in five structured aerobic exercise sessions throughout the experimental protocol.
GLU
ACTIVE COMPARATORSubjects will consume a 75g glucose beverage three times daily for seven days without participating in structured aerobic exercise.
Interventions
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.
Subjects will consume a 75g glucose beverage three times daily over a seven-day period.
Eligibility Criteria
You may qualify if:
- \- Healthy young men 18-35 years of age.
You may not qualify if:
- 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
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
Medical Education Building
Iowa City, Iowa, 52242, United States
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- NONE
- Purpose
- BASIC SCIENCE
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- Assistant Professor
Study Record Dates
First Submitted
August 22, 2018
First Posted
August 29, 2018
Study Start
October 15, 2018
Primary Completion
October 21, 2019
Study Completion
October 21, 2019
Last Updated
March 24, 2020
Record last verified: 2020-03
Data Sharing
- IPD Sharing
- Will not share