Working...
ClinicalTrials.gov
ClinicalTrials.gov Menu

Hyperglycemia, Exercise, and Endothelial Function

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
ClinicalTrials.gov Identifier: NCT03651713
Recruitment Status : Recruiting
First Posted : August 29, 2018
Last Update Posted : January 9, 2019
Sponsor:
Information provided by (Responsible Party):
Darren P Casey, University of Iowa

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.

Condition or disease Intervention/treatment Phase
Endothelial Function Hyperglycemia Behavioral: GLU+EX Dietary Supplement: GLU Not Applicable

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.

Layout table for study information
Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 30 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Intervention Model Description: Randomized
Masking: None (Open Label)
Primary Purpose: Basic Science
Official Title: Effect of Short-Term Glucose Loading on Vascular Function
Actual Study Start Date : October 15, 2018
Estimated Primary Completion Date : September 1, 2019
Estimated Study Completion Date : September 1, 2019

Resource links provided by the National Library of Medicine


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.




Primary Outcome Measures :
  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 Outcome Measures :
  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 Outcome Measures:
  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.



Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Layout table for eligibility information
Ages Eligible for Study:   18 Years to 35 Years   (Adult)
Sexes Eligible for Study:   Male
Accepts Healthy Volunteers:   Yes
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03651713


Contacts
Layout table for location contacts
Contact: Darren P Casey, PhD 319-384-1009 darren-casey@uiowa.edu

Locations
Layout table for location information
United States, Iowa
Medical Education Building Recruiting
Iowa City, Iowa, United States, 52242
Contact: Darren P Casey, Ph.D.    319-334-1009    darren-casey@uiowa.edu   
Sponsors and Collaborators
University of Iowa

Layout table for additonal information
Responsible Party: Darren P Casey, Assistant Professor, University of Iowa
ClinicalTrials.gov Identifier: NCT03651713     History of Changes
Other Study ID Numbers: 201807752
First Posted: August 29, 2018    Key Record Dates
Last Update Posted: January 9, 2019
Last Verified: January 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

Layout table for additional information
Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No

Keywords provided by Darren P Casey, University of Iowa:
exercise
glucose
vascular function

Additional relevant MeSH terms:
Layout table for MeSH terms
Hyperglycemia
Glucose Metabolism Disorders
Metabolic Diseases