NCT00882986

Brief Summary

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
20

participants targeted

Target at below P25 for all trials

Timeline
Completed

Started Jan 2009

Typical duration for all trials

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

January 1, 2009

Completed
3 months until next milestone

First Submitted

Initial submission to the registry

April 14, 2009

Completed
3 days until next milestone

First Posted

Study publicly available on registry

April 17, 2009

Completed
2.3 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

August 1, 2011

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

August 1, 2011

Completed
Last Updated

September 24, 2015

Status Verified

September 1, 2015

Enrollment Period

2.6 years

First QC Date

April 14, 2009

Last Update Submit

September 22, 2015

Conditions

Insulin Resistance

Keywords

insulin resistance

Outcome Measures

Primary Outcomes (1)

  • insulin/glucose response to mixed meal ingestion

    This study is cross-sectional. Primary and secondary measures will be assessed at a single timepoint.

Secondary Outcomes (2)

  • MSNA

    This is a cross-sectional study. Primary and seconardy measures will be assessed at a single visit lasting 4-6 hours.

  • Blood flow

    This is a cross-sectional study. Primary and seconardy measures will be assessed at a single visit lasting 4-6 hours.

Study Arms (2)

1

Men with high fitness (above VO2max of 60)

2

Men with average fitness (below VO2max of 50)

Eligibility Criteria

Age20 Years - 50 Years
Sexmale
Healthy VolunteersYes
Age GroupsAdult (18-64)
Sampling MethodNon-Probability Sample
Study Population

young, lean, healthy men

You may qualify if:

  • healthy, not currently taking any medications

You may not qualify if:

  • unhealthy, taking medications

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

University of Kansas Medical Center

Kansas City, Kansas, 66160, United States

Location

MeSH Terms

Conditions

Insulin Resistance

Condition Hierarchy (Ancestors)

HyperinsulinismGlucose Metabolism DisordersMetabolic DiseasesNutritional and Metabolic Diseases

Study Officials

  • John P Thyfault, PhD

    University of Kansas Medical Center

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
observational
Observational Model
CASE CONTROL
Time Perspective
CROSS SECTIONAL
Sponsor Type
OTHER
Responsible Party
SPONSOR INVESTIGATOR
PI Title
Associate Professor

Study Record Dates

First Submitted

April 14, 2009

First Posted

April 17, 2009

Study Start

January 1, 2009

Primary Completion

August 1, 2011

Study Completion

August 1, 2011

Last Updated

September 24, 2015

Record last verified: 2015-09

Locations

US(1)