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Cardiovascular and Metabolic Responses to a Mixed Meal

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT00882986
First Posted: April 17, 2009
Last Update Posted: September 24, 2015
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. Read our disclaimer for details.
Information provided by (Responsible Party):
John Thyfault, University of Kansas Medical Center Research Institute
  Purpose
The purpose is to determine whether regular endurance exercise and/or body weight influence the way our nervous and vascular systems respond during the metabolism of meals.

Condition
Insulin Resistance

Study Type: Observational
Study Design: Observational Model: Case Control
Time Perspective: Cross-Sectional
Official Title: Role of Exercise Training and Body Weight on Cardiovascular and Metabolic Responses to a Mixed Meal Tolerance Test

Further study details as provided by John Thyfault, University of Kansas Medical Center Research Institute:

Primary Outcome Measures:
  • insulin/glucose response to mixed meal ingestion [ Time Frame: This study is cross-sectional. Primary and secondary measures will be assessed at a single timepoint. ]

Secondary Outcome Measures:
  • MSNA [ Time Frame: This is a cross-sectional study. Primary and seconardy measures will be assessed at a single visit lasting 4-6 hours. ]
  • Blood flow [ Time Frame: This is a cross-sectional study. Primary and seconardy measures will be assessed at a single visit lasting 4-6 hours. ]

Enrollment: 20
Study Start Date: January 2009
Study Completion Date: August 2011
Primary Completion Date: August 2011 (Final data collection date for primary outcome measure)
Groups/Cohorts
1
Men with high fitness (above VO2max of 60)
2
Men with average fitness (below VO2max of 50)

Detailed Description:
To begin to examine this question we recruited healthy endurance-trained (high fit, HF) and normally active (average fit, AF) subjects. It is well characterized that chronic endurance training results in enhanced peripheral insulin sensitivity. Therefore, our rationale was that inclusion of two healthy subject groups, with distinct differences in insulin sensitivity, would allow us to investigate how enhanced insulin sensitivity influences insulin-mediated changes in central sympathetic outflow. Direct measurements of central sympathetic outflow to skeletal muscle (i.e., MSNA) were recorded, and a mixed meal was used as a physiological method to evoke robust and sustained increases in MSNA, which have been primarily attributed to insulin. We hypothesized that HF subjects would have a greater MSNA response, for a given plasma insulin concentration, following consumption of a mixed meal (i.e., greater central insulin sensitivity).
  Eligibility

Information from the National Library of Medicine

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Ages Eligible for Study:   20 Years to 50 Years   (Adult)
Sexes Eligible for Study:   Male
Accepts Healthy Volunteers:   Yes
Sampling Method:   Non-Probability Sample
Study Population
young, lean, healthy men
Criteria

Inclusion Criteria:

  • healthy, not currently taking any medications

Exclusion Criteria:

  • unhealthy, taking medications
  Contacts and Locations
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): NCT00882986


Locations
United States, Kansas
University of Kansas Medical Center
Kansas City, Kansas, United States, 66160
Sponsors and Collaborators
John Thyfault
Investigators
Principal Investigator: John P Thyfault, PhD University of Kansas Medical Center
  More Information

Responsible Party: John Thyfault, Associate Professor, University of Kansas Medical Center Research Institute
ClinicalTrials.gov Identifier: NCT00882986     History of Changes
Other Study ID Numbers: 1121717
First Submitted: April 14, 2009
First Posted: April 17, 2009
Last Update Posted: September 24, 2015
Last Verified: September 2015

Keywords provided by John Thyfault, University of Kansas Medical Center Research Institute:
insulin resistance

Additional relevant MeSH terms:
Insulin Resistance
Hyperinsulinism
Glucose Metabolism Disorders
Metabolic Diseases