Hyperglycemia, Exercise, and Endothelial Function

Effect of Short-Term Glucose Loading on Vascular Function

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.

Study Overview

• Status: Completed
• Conditions: Hyperglycemia; Endothelial Function
• Intervention / Treatment: Behavioral: GLU+EX; Dietary supplement: GLU

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.

• Study Type: Interventional
• Enrollment (Actual): 32
• Phase: Not Applicable

Contacts and Locations

Study Locations

• United States
  • Iowa
    • Iowa City, Iowa, United States, 52242
      • Medical Education Building

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 35 years (Adult)
• Accepts Healthy Volunteers: Yes
• Genders Eligible for Study: Male

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Basic Science
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: GLU+EX; 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.	Behavioral: GLU+EX; 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.
Active Comparator: GLU; Subjects will consume a 75g glucose beverage three times daily for seven days without participating in structured aerobic exercise.	Dietary supplement: GLU; Subjects will consume a 75g glucose beverage three times daily over a seven-day period.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
Central Blood Pressure	Aortic blood pressure will be derived from radial artery pressure wave measurements (via applanation tonometry) during resting conditions.	Before and after the seven-day intervention in both groups.

Other Outcome Measures

Outcome Measure	Measure Description	Time Frame
Physical Activity	Steps per day will be recorded via accelerometry throughout the intervention in both groups.	Continuously throughout the seven-day intervention.
Caloric Consumption	Subjects will record their dietary intake throughout the intervention.	Continuously throughout the seven-day intervention.

Collaborators and Investigators

• Sponsor: University of Iowa

Study record dates

Study Major Dates

• Study Start (Actual): October 15, 2018
• Primary Completion (Actual): October 21, 2019
• Study Completion (Actual): October 21, 2019

Study Registration Dates

• First Submitted: August 22, 2018
• First Submitted That Met QC Criteria: August 27, 2018
• First Posted (Actual): August 29, 2018

Study Record Updates

• Last Update Posted (Actual): March 24, 2020
• Last Update Submitted That Met QC Criteria: March 23, 2020
• Last Verified: March 1, 2020

More Information

Terms related to this study

• Keywords: exercise; vascular function; glucose
• Additional Relevant MeSH Terms: Glucose Metabolism Disorders; Metabolic Diseases; Hyperglycemia
• Other Study ID Numbers: 201807752

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No