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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT03651713
Other study ID # 201807752
Secondary ID
Status Completed
Phase N/A
First received
Last updated
Start date October 15, 2018
Est. completion date October 21, 2019

Study information

Verified date March 2020
Source University of Iowa
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial 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.


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.


Recruitment information / eligibility

Status Completed
Enrollment 32
Est. completion date October 21, 2019
Est. primary completion date October 21, 2019
Accepts healthy volunteers Accepts Healthy Volunteers
Gender Male
Age group 18 Years to 35 Years
Eligibility 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 Design


Related Conditions & MeSH terms


Intervention

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

Locations

Country Name City State
United States Medical Education Building Iowa City Iowa

Sponsors (1)

Lead Sponsor Collaborator
University of Iowa

Country where clinical trial is conducted

United States, 

Outcome

Type Measure Description Time frame Safety issue
Other Physical Activity Steps per day will be recorded via accelerometry throughout the intervention in both groups. Continuously throughout the seven-day intervention.
Other Caloric Consumption Subjects will record their dietary intake throughout the intervention. Continuously throughout the seven-day intervention.
Primary 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 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.
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