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Cardiovascular and Metabolic Responses to a Mixed Meal

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
John Thyfault, University of Kansas Medical Center Research Institute
ClinicalTrials.gov Identifier:
NCT00882986
First received: April 14, 2009
Last updated: September 22, 2015
Last verified: September 2015
  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 University of Kansas Medical Center:

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. ] [ Designated as safety issue: No ]

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. ] [ Designated as safety issue: No ]
  • 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. ] [ Designated as safety issue: No ]

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

Ages Eligible for Study:   20 Years to 50 Years   (Adult)
Genders 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
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, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: 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 
Study First Received: April 14, 2009
Last Updated: September 22, 2015
Health Authority: United States: Institutional Review Board

Keywords provided by University of Kansas Medical Center:
insulin resistance

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

ClinicalTrials.gov processed this record on December 09, 2016