Trial Outcomes & Findings for Acute Cardiovascular and Metabolic Effects of Exercise Training in Individuals With Insulin Resistance (NCT NCT00954109)

Last Updated: 2015-04-06

Results Overview

Insulin sensitivity measured during an oral glucose tolerance test measured by the Matsuda Index. Matsuda insulin sensitivity index= 10000/square root of \[(fasting glucose × fasting insulin) × (mean glucose × mean insulin during oral glucose tolerance test).

Recruitment status

COMPLETED

Study phase

Target enrollment

11 participants

Primary outcome timeframe

baseline and 24h after 5-7 days of exercise

Results posted on

2015-04-06

Participant Flow

Participant milestones

Participant milestones
Measure	Exercise exercise - supervised exercise (treadmill walking or cycle ergometer use) Exercise: daily exercise: supervised treadmill walking or cycle ergometry use
Overall Study STARTED	11
Overall Study COMPLETED	11
Overall Study NOT COMPLETED	0

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

Acute Cardiovascular and Metabolic Effects of Exercise Training in Individuals With Insulin Resistance

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Arm 1 n=11 Participants exercise - supervised exercise (treadmill walking or cycle ergometer use) Exercise: daily exercise: supervised treadmill walking or cycle ergometry use
Age, Categorical <=18 years	0 Participants n=93 Participants
Age, Categorical Between 18 and 65 years	11 Participants n=93 Participants
Age, Categorical >=65 years	0 Participants n=93 Participants
Age, Continuous	53 years STANDARD_DEVIATION 2 • n=93 Participants
Sex: Female, Male Female	5 Participants n=93 Participants
Sex: Female, Male Male	6 Participants n=93 Participants
Race (NIH/OMB) American Indian or Alaska Native	0 Participants n=93 Participants
Race (NIH/OMB) Asian	0 Participants n=93 Participants
Race (NIH/OMB) Native Hawaiian or Other Pacific Islander	0 Participants n=93 Participants
Race (NIH/OMB) Black or African American	1 Participants n=93 Participants
Race (NIH/OMB) White	10 Participants n=93 Participants
Race (NIH/OMB) More than one race	0 Participants n=93 Participants
Race (NIH/OMB) Unknown or Not Reported	0 Participants n=93 Participants
Region of Enrollment United States	11 participants n=93 Participants

PRIMARY outcome

Timeframe: baseline and 24h after 5-7 days of exercise

Outcome measures

Outcome measures
Measure	Arm 1 n=11 Participants exercise - supervised exercise (treadmill walking or cycle ergometer use) Exercise: daily exercise: supervised treadmill walking or cycle ergometry use
Insulin Sensitivity After 5-7 Days of Exercise Baseline	3 index score Standard Error .2
Insulin Sensitivity After 5-7 Days of Exercise Post 5-7 days of exercise	2.5 index score Standard Error 0.3

PRIMARY outcome

Timeframe: pre and 24 hours post 5-7 days of exercise

Blood flow response in the femoral artery measured by Doppler ultrasound during and oral glucose tolerance test. Data are represented as % change in blood flow during the oral glucose tolerance at 60 minutes vs. 0 minutes (prior to drinking the glucose)

Outcome measures

Outcome measures
Measure	Arm 1 n=11 Participants exercise - supervised exercise (treadmill walking or cycle ergometer use) Exercise: daily exercise: supervised treadmill walking or cycle ergometry use
Blood Flow in Response to Oral Glucose Tolerance Tests Post 5-7 days of exercise	40 percentage change Standard Error 20
Blood Flow in Response to Oral Glucose Tolerance Tests Baseline	0 percentage change Standard Error 2

Adverse Events

Arm 1

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Serious adverse events

Adverse event data not reported

Other adverse events

Adverse event data not reported

Additional Information

John Thyfault, Associate Professor

Harry S Truman Memorial VA Hospital and University of Missouri

Phone: 573-814-6000

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee
Publication restrictions are in place