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Completed

NCT Number: NCT03651713

Hyperglycemia, Exercise, and Endothelial 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.

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Key information

Conditions

Endothelial Function Behavior Glucose Metabolism Disorders Hyperglycemia Metabolic Diseases Motor Activity Nutritional and Metabolic Diseases

Age range

18 year–35 year

Sex eligibility

Male

Study type

Interventional

Phase

Not applicable

Primary location

Medical Education Building

Iowa City, Iowa, 52242, United States

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

GLU+EX

Behavioral

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.

GLU

Dietary Supplement

Subjects will consume a 75g glucose beverage three times daily over a seven-day period.

Primary outcomes

  1. Change in Vascular Endothelial Function

    Time frame: Before and after the seven-day intervention in both groups.

    Brachial artery flow-mediated dilation (%), measured via Doppler ultrasound, will be assessed before and after the intervention.

Secondary outcomes

  1. Central Blood Pressure

    Time frame: Before and after the seven-day intervention in both groups.

    Aortic blood pressure will be derived from radial artery pressure wave measurements (via applanation tonometry) during resting conditions.

Other outcomes

  1. Physical Activity

    Time frame: Continuously throughout the seven-day intervention.

    Steps per day will be recorded via accelerometry throughout the intervention in both groups.

  2. Caloric Consumption

    Time frame: Continuously throughout the seven-day intervention.

    Subjects will record their dietary intake throughout the intervention.

Sponsors and collaborators

Lead sponsor

University of Iowa

Other

Registry information

Official study title

Effect of Short-Term Glucose Loading on Vascular Function

Important dates

Study start
2018
Primary completion
2019
Study completion
2019
First posted
Aug 29, 2018
Registry last updated
Mar 24, 2020

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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