Insulin Resistance
Conditions
Keywords
Insulin Resistance, Type 2 Diabetes
Brief summary
The overall aim of the project is to determine whether or not exercise influences cardiovascular or nervous responses to meal ingestion in individuals with insulin resistance or type 2 diabetes.
Detailed description
Participants will undergo a screening procedure, including telephone screening and physical examination, as well as determination of body composition and fitness. Participants will be asked to complete 5-10 days of supervised exercise training and will undergo testing to assess cardiovascular and metabolic responses to an oral glucose tolerance test, including muscle sympathetic nerve activity, blood flow, and circulating glucose and insulin concentrations at baseline and following training. In addition, day-to-day variations in blood glucose will also be monitored. The overall aim of the project is to determine whether or not acute exercise training influences postprandial metabolic, vascular or autonomic nervous system responses in individuals with insulin resistance or T2D.
Interventions
BEHAVIORALExercise
daily exercise: supervised treadmill walking or cycle ergometry use
Sponsors
US Department of Veterans Affairs
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
30 Years to 65 Years
Healthy volunteers
No
Inclusion criteria
* Insulin resistant: diagnosed with pre-diabetes or fasting blood glucose \>/= 100 mg/dL * T2D: diagnosed by primary care physician * BMI: less than 43 kg/m2 * Age: 30-65
Exclusion criteria
* Smoking * Insulin use (other than once daily) * Underlying conditions that limit ability to exercise safely * Recent weight gain or loss (\>5% of body weight in 3 months) * Physically active (\>30 min aerobic exercise, 2 d/wk) * Recent (\<3 mo) changes in medication use or dose * Uncontrolled T2D (HbA1c\>10%) * Advanced retinopathy or neuropathy * Pregnancy
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Insulin Sensitivity After 5-7 Days of Exercise | baseline and 24h after 5-7 days of exercise | 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). |
| Blood Flow in Response to Oral Glucose Tolerance Tests | 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) |
Countries
United States
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| Arm 1 exercise - supervised exercise (treadmill walking or cycle ergometer use)
Exercise: daily exercise: supervised treadmill walking or cycle ergometry use | 11 |
| Total | 11 |
Baseline characteristics
| Characteristic | Arm 1 |
|---|---|
| Age, Categorical <=18 years | 0 Participants |
| Age, Categorical >=65 years | 0 Participants |
| Age, Categorical Between 18 and 65 years | 11 Participants |
| Age, Continuous | 53 years STANDARD_DEVIATION 2 |
| Race (NIH/OMB) American Indian or Alaska Native | 0 Participants |
| Race (NIH/OMB) Asian | 0 Participants |
| Race (NIH/OMB) Black or African American | 1 Participants |
| Race (NIH/OMB) More than one race | 0 Participants |
| Race (NIH/OMB) Native Hawaiian or Other Pacific Islander | 0 Participants |
| Race (NIH/OMB) Unknown or Not Reported | 0 Participants |
| Race (NIH/OMB) White | 10 Participants |
| Region of Enrollment United States | 11 participants |
| Sex: Female, Male Female | 5 Participants |
| Sex: Female, Male Male | 6 Participants |
Adverse events
| Event type | EG000 affected / at risk |
|---|---|
| deaths Total, all-cause mortality | — / — |
| other Total, other adverse events | 0 / 11 |
| serious Total, serious adverse events | 0 / 11 |
Outcome results
Primary
Blood Flow in Response to Oral Glucose Tolerance Tests
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)
Time frame: pre and 24 hours post 5-7 days of exercise
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Arm 1 | Blood Flow in Response to Oral Glucose Tolerance Tests | Baseline | 0 percentage change | Standard Error 2 |
| Arm 1 | Blood Flow in Response to Oral Glucose Tolerance Tests | Post 5-7 days of exercise | 40 percentage change | Standard Error 20 |
p-value: <0.05t-test, 1 sided
Primary
Insulin Sensitivity After 5-7 Days of Exercise
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).
Time frame: baseline and 24h after 5-7 days of exercise
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Arm 1 | Insulin Sensitivity After 5-7 Days of Exercise | Baseline | 3 index score | Standard Error 0.2 |
| Arm 1 | Insulin Sensitivity After 5-7 Days of Exercise | Post 5-7 days of exercise | 2.5 index score | Standard Error 0.3 |
p-value: <0.05t-test, 1 sided