Trial Outcomes & Findings for Influence of Endothelial Function on Central and Peripheral Causes Of Exercise Impairment in Type 2 Diabetes (NCT NCT00786019)
NCT ID: NCT00786019
Last Updated: 2023-07-12
Results Overview
Characterize the purported cardiac dysfunction during exercise in people with type 2 diabetes (T2D). In a normal patient when measuring circumferential strain, results are negative with downward tracing (as strain is a relative change in length). Circumferential strain is a measurement of ventricular circumference within the heart vessels, measured via echocardiography.
Recruitment status
COMPLETED
Study phase
NA
Target enrollment
47 participants
Primary outcome timeframe
7 months; Measures are made at rest and after exercise for baseline, at rest and after infusion for Vitamin C administration, and at rest and after exercise following the exercise training
Results posted on
2023-07-12
Participant Flow
Participant milestones
| Measure |
Ascorbic Acid - Control
All study subjects have ascorbic acid infusion during one exercise visit as well as a three month exercise training intervention.
Exercise program: Three month exercise program located at the Anschutz Medical Campus. The program runs three times per week for about an hour each session.
Ascorbic Acid (Vitamin C): During one exercise study visit, 0.06 grams of Vitamin C per kilogram (kg) fat-free mass per 100 milliliters (mL) of normal saline administered; Subjects will receive a bolus of 100mL Vitamin C solution given at 5ml/minute over 20 minutes followed by a "drip-infusion" given at 1.7ml/minute.
|
Ascorbic Acid - Type 2 Diabetes
All study subjects have ascorbic acid infusion during one exercise visit as well as a three month exercise training intervention.
Exercise program: Three month exercise program located at the Anschutz Medical Campus. The program runs three times per week for about an hour each session.
Ascorbic Acid (Vitamin C): During one exercise study visit, 0.06 grams Vitamin C per kilogram fat-free mass per 100 milliliters (mL) of normal saline administered; Subjects will receive a bolus of 100mL Vitamin C solution given at 5ml/minute over 20 minutes followed by a "drip-infusion" given at 1.7ml/minute.
|
|---|---|---|
|
Overall Study
STARTED
|
20
|
27
|
|
Overall Study
COMPLETED
|
15
|
17
|
|
Overall Study
NOT COMPLETED
|
5
|
10
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
Influence of Endothelial Function on Central and Peripheral Causes Of Exercise Impairment in Type 2 Diabetes
Baseline characteristics by cohort
| Measure |
Ascorbic Acid - Control
n=20 Participants
All study subjects have ascorbic acid infusion during one exercise visit as well as a three month exercise training intervention.
Exercise program: Three month exercise program located at the Anschutz Medical Campus. The program runs three times per week for about an hour each session.
Ascorbic Acid (Vitamin C): During one exercise study visit, 0.06 grams of Vitamin C per kilogram (kg) fat-free mass per 100 milliliters (mL) of normal saline administered; Subjects will receive a bolus of 100mL Vitamin C solution given at 5ml/minute over 20 minutes followed by a "drip-infusion" given at 1.7ml/minute.
|
Ascorbic Acid - Type 2 Diabetes
n=27 Participants
All study subjects have ascorbic acid infusion during one exercise visit as well as a three month exercise training intervention.
Exercise program: Three month exercise program located at the Anschutz Medical Campus. The program runs three times per week for about an hour each session.
Ascorbic Acid (Vitamin C): During one exercise study visit, 0.06 grams of Vitamin C per kilogram (kg) fat-free mass per 100 milliliters (mL) of normal saline administered; Subjects will receive a bolus of 100mL Vitamin C solution given at 5ml/minute over 20 minutes followed by a "drip-infusion" given at 1.7ml/minute.
|
Total
n=47 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Continuous
|
45.4 years
STANDARD_DEVIATION 6.0 • n=5 Participants
|
46.5 years
STANDARD_DEVIATION 5.7 • n=7 Participants
|
46.0 years
STANDARD_DEVIATION 6.0 • n=5 Participants
|
|
Sex: Female, Male
Female
|
11 Participants
n=5 Participants
|
6 Participants
n=7 Participants
|
17 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
9 Participants
n=5 Participants
|
21 Participants
n=7 Participants
|
30 Participants
n=5 Participants
|
|
Race/Ethnicity, Customized
Asian
|
0 Participants
n=5 Participants
|
2 Participants
n=7 Participants
|
2 Participants
n=5 Participants
|
|
Race/Ethnicity, Customized
Black/African American
|
6 Participants
n=5 Participants
|
7 Participants
n=7 Participants
|
13 Participants
n=5 Participants
|
|
Race/Ethnicity, Customized
Hispanic
|
4 Participants
n=5 Participants
|
5 Participants
n=7 Participants
|
9 Participants
n=5 Participants
|
|
Race/Ethnicity, Customized
White
|
10 Participants
n=5 Participants
|
11 Participants
n=7 Participants
|
21 Participants
n=5 Participants
|
|
Race/Ethnicity, Customized
American Indian
|
0 Participants
n=5 Participants
|
1 Participants
n=7 Participants
|
1 Participants
n=5 Participants
|
|
Race/Ethnicity, Customized
Other
|
0 Participants
n=5 Participants
|
1 Participants
n=7 Participants
|
1 Participants
n=5 Participants
|
|
Region of Enrollment
United States
|
20 Participants
n=5 Participants
|
27 Participants
n=7 Participants
|
47 Participants
n=5 Participants
|
|
Height (cm)
|
171.30 centimeters
STANDARD_DEVIATION 10.8 • n=5 Participants
|
175.17 centimeters
STANDARD_DEVIATION 8.7 • n=7 Participants
|
173.52 centimeters
STANDARD_DEVIATION 9.7 • n=5 Participants
|
|
Weight (kg)
|
89.67 kilograms
STANDARD_DEVIATION 10.8 • n=5 Participants
|
97.89 kilograms
STANDARD_DEVIATION 18.0 • n=7 Participants
|
94.39 kilograms
STANDARD_DEVIATION 15.8 • n=5 Participants
|
|
Body Mass Index (BMI)
|
30.60 kg/m^2
STANDARD_DEVIATION 3.0 • n=5 Participants
|
31.75 kg/m^2
STANDARD_DEVIATION 4.7 • n=7 Participants
|
31.26 kg/m^2
STANDARD_DEVIATION 4.0 • n=5 Participants
|
|
Body Fat Percentage (%)
|
35.00 percentage
STANDARD_DEVIATION 7.0 • n=5 Participants
|
32.61 percentage
STANDARD_DEVIATION 6.1 • n=7 Participants
|
33.63 percentage
STANDARD_DEVIATION 6.5 • n=5 Participants
|
|
Glucose (mg/dL)
|
87.15 mg/dL
STANDARD_DEVIATION 5.7 • n=5 Participants
|
118.33 mg/dL
STANDARD_DEVIATION 22.2 • n=7 Participants
|
105.06 mg/dL
STANDARD_DEVIATION 23.1 • n=5 Participants
|
|
Insulin (uIU/mL)
|
15.45 uIU/mL
STANDARD_DEVIATION 7.7 • n=5 Participants
|
29.93 uIU/mL
STANDARD_DEVIATION 19.6 • n=7 Participants
|
23.77 uIU/mL
STANDARD_DEVIATION 17.1 • n=5 Participants
|
|
Total Cholesterol (mg/dL)
|
173.45 mg/dL
STANDARD_DEVIATION 28.8 • n=5 Participants
|
147.30 mg/dL
STANDARD_DEVIATION 20.6 • n=7 Participants
|
158.43 mg/dL
STANDARD_DEVIATION 27.5 • n=5 Participants
|
|
Triglycerides (mg/dL)
|
108.55 mg/dL
STANDARD_DEVIATION 37.1 • n=5 Participants
|
151.52 mg/dL
STANDARD_DEVIATION 65.5 • n=7 Participants
|
133.23 mg/dL
STANDARD_DEVIATION 58.8 • n=5 Participants
|
|
LDL Cholesterol (mg/dL)
|
105.00 mg/dL
STANDARD_DEVIATION 22.4 • n=5 Participants
|
87.33 mg/dL
STANDARD_DEVIATION 19.2 • n=7 Participants
|
94.85 mg/dL
STANDARD_DEVIATION 22.2 • n=5 Participants
|
|
HDL Cholesterol (mg/dL)
|
52.2 mg/dL
STANDARD_DEVIATION 13.0 • n=5 Participants
|
38.26 mg/dL
STANDARD_DEVIATION 8.1 • n=7 Participants
|
44.19 mg/dL
STANDARD_DEVIATION 12.5 • n=5 Participants
|
|
Hemoglobin A1c
|
5.37 percentage
STANDARD_DEVIATION 0.4 • n=5 Participants
|
6.85 percentage
STANDARD_DEVIATION 0.7 • n=7 Participants
|
6.22 percentage
STANDARD_DEVIATION 1.0 • n=5 Participants
|
|
Peak VO2 (relative)
|
22.32 mL/kg/min
STANDARD_DEVIATION 4.9 • n=5 Participants
|
20.93 mL/kg/min
STANDARD_DEVIATION 3.8 • n=7 Participants
|
21.52 mL/kg/min
STANDARD_DEVIATION 4.3 • n=5 Participants
|
|
Peak VO2 (absolute)
|
2027.65 mL/min
STANDARD_DEVIATION 529.2 • n=5 Participants
|
2076.67 mL/min
STANDARD_DEVIATION 531.6 • n=7 Participants
|
2055.81 mL/min
STANDARD_DEVIATION 525.3 • n=5 Participants
|
PRIMARY outcome
Timeframe: 7 months; Measures are made at rest and after exercise for baseline, at rest and after infusion for Vitamin C administration, and at rest and after exercise following the exercise trainingCharacterize the purported cardiac dysfunction during exercise in people with type 2 diabetes (T2D). In a normal patient when measuring circumferential strain, results are negative with downward tracing (as strain is a relative change in length). Circumferential strain is a measurement of ventricular circumference within the heart vessels, measured via echocardiography.
Outcome measures
| Measure |
Circumferential Strain - Control
n=15 Participants
All study subjects have ascorbic acid infusion during one exercise visit as well as a three month exercise training intervention.
Exercise program: Three month exercise program located at the Anschutz Medical Campus. The program runs three times per week for about an hour each session.
Ascorbic Acid (Vitamin C): During one exercise study visit, 0.06 grams of Vitamin C per kilogram (kg) fat-free mass per 100 milliliters (mL) of normal saline administered; Subjects will receive a bolus of 100mL Vitamin C solution given at 5ml/minute over 20 minutes followed by a "drip-infusion" given at 1.7ml/minute.
|
Circumferential Strain - Type 2 Diabetes
n=17 Participants
All study subjects have ascorbic acid infusion during one exercise visit as well as a three month exercise training intervention.
Exercise program: Three month exercise program located at the Anschutz Medical Campus. The program runs three times per week for about an hour each session.
Ascorbic Acid (Vitamin C): During one exercise study visit, 0.06 grams of Vitamin C per kilogram (kg) fat-free mass per 100 milliliters (mL) of normal saline administered; Subjects will receive a bolus of 100mL Vitamin C solution given at 5ml/minute over 20 minutes followed by a "drip-infusion" given at 1.7ml/minute.
|
|---|---|---|
|
Percent Change in Circumferential Strain Before and After Exercise at Baseline, After Vitamin C Infusion, and After Exercise Training
Baseline
|
-24 percentage of change in length
Standard Deviation 1
|
-20 percentage of change in length
Standard Deviation 1
|
|
Percent Change in Circumferential Strain Before and After Exercise at Baseline, After Vitamin C Infusion, and After Exercise Training
Vitamin C
|
-23 percentage of change in length
Standard Deviation 1
|
-21 percentage of change in length
Standard Deviation 1
|
|
Percent Change in Circumferential Strain Before and After Exercise at Baseline, After Vitamin C Infusion, and After Exercise Training
Post Exercise Training
|
-22 percentage of change in length
Standard Deviation 1
|
-22 percentage of change in length
Standard Deviation 1
|
PRIMARY outcome
Timeframe: 7 months; Measures are made at rest for baseline, at rest for Vitamin C administration, and at rest following the exercise trainingEvaluate potential changes in cardiac function by echocardiography following 2 interventions: Three months of exercise training and acute vitamin C administration. Ejection fraction (EF) is a measurement of the percentage of blood leaving your heart each time it contracts, typically measure by echocardiography. Numbers listed are absolute EF values.
Outcome measures
| Measure |
Circumferential Strain - Control
n=15 Participants
All study subjects have ascorbic acid infusion during one exercise visit as well as a three month exercise training intervention.
Exercise program: Three month exercise program located at the Anschutz Medical Campus. The program runs three times per week for about an hour each session.
Ascorbic Acid (Vitamin C): During one exercise study visit, 0.06 grams of Vitamin C per kilogram (kg) fat-free mass per 100 milliliters (mL) of normal saline administered; Subjects will receive a bolus of 100mL Vitamin C solution given at 5ml/minute over 20 minutes followed by a "drip-infusion" given at 1.7ml/minute.
|
Circumferential Strain - Type 2 Diabetes
n=17 Participants
All study subjects have ascorbic acid infusion during one exercise visit as well as a three month exercise training intervention.
Exercise program: Three month exercise program located at the Anschutz Medical Campus. The program runs three times per week for about an hour each session.
Ascorbic Acid (Vitamin C): During one exercise study visit, 0.06 grams of Vitamin C per kilogram (kg) fat-free mass per 100 milliliters (mL) of normal saline administered; Subjects will receive a bolus of 100mL Vitamin C solution given at 5ml/minute over 20 minutes followed by a "drip-infusion" given at 1.7ml/minute.
|
|---|---|---|
|
Ejection Fraction: Percentage of Blood Leaving the Heart Before and After Exercise at Baseline, After a Vitamin C Infusion, and After Exercise Training
Baseline
|
65 percentage of blood leaving the heart
Standard Deviation 2
|
65 percentage of blood leaving the heart
Standard Deviation 1
|
|
Ejection Fraction: Percentage of Blood Leaving the Heart Before and After Exercise at Baseline, After a Vitamin C Infusion, and After Exercise Training
Vitamin C
|
67 percentage of blood leaving the heart
Standard Deviation 2
|
63 percentage of blood leaving the heart
Standard Deviation 1
|
|
Ejection Fraction: Percentage of Blood Leaving the Heart Before and After Exercise at Baseline, After a Vitamin C Infusion, and After Exercise Training
Post Exercise Training
|
61 percentage of blood leaving the heart
Standard Deviation 3
|
65 percentage of blood leaving the heart
Standard Deviation 3
|
Adverse Events
Ascorbic Acid - Control
Serious events: 1 serious events
Other events: 0 other events
Deaths: 0 deaths
Ascorbic Acid - T2D
Serious events: 1 serious events
Other events: 2 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
Ascorbic Acid - Control
n=20 participants at risk
All study subjects have ascorbic acid infusion during one exercise visit as well as a three month exercise training intervention.
Exercise program: Three month exercise program located at the Anschutz Medical Campus. The program runs three times per week for about an hour each session.
Ascorbic Acid (Vitamin C): During one exercise study visit, 0.06 g Vit C per kg fat-free mass per 100 ml of normal saline administered; Subjects will receive a bolus of 100mL Vit C solution given at 5ml/min over 20minutes followed by a "drip-infusion" given at 1.7ml/min.
|
Ascorbic Acid - T2D
n=27 participants at risk
All study subjects have ascorbic acid infusion during one exercise visit as well as a three month exercise training intervention.
Exercise program: Three month exercise program located at the Anschutz Medical Campus. The program runs three times per week for about an hour each session.
Ascorbic Acid (Vitamin C): During one exercise study visit, 0.06 g Vit C per kg fat-free mass per 100 ml of normal saline administered; Subjects will receive a bolus of 100mL Vit C solution given at 5ml/min over 20minutes followed by a "drip-infusion" given at 1.7ml/min.
|
|---|---|---|
|
Pregnancy, puerperium and perinatal conditions
Pregnancy
|
5.0%
1/20
|
0.00%
0/27
|
|
Injury, poisoning and procedural complications
Needle stick
|
0.00%
0/20
|
3.7%
1/27
|
Other adverse events
| Measure |
Ascorbic Acid - Control
n=20 participants at risk
All study subjects have ascorbic acid infusion during one exercise visit as well as a three month exercise training intervention.
Exercise program: Three month exercise program located at the Anschutz Medical Campus. The program runs three times per week for about an hour each session.
Ascorbic Acid (Vitamin C): During one exercise study visit, 0.06 g Vit C per kg fat-free mass per 100 ml of normal saline administered; Subjects will receive a bolus of 100mL Vit C solution given at 5ml/min over 20minutes followed by a "drip-infusion" given at 1.7ml/min.
|
Ascorbic Acid - T2D
n=27 participants at risk
All study subjects have ascorbic acid infusion during one exercise visit as well as a three month exercise training intervention.
Exercise program: Three month exercise program located at the Anschutz Medical Campus. The program runs three times per week for about an hour each session.
Ascorbic Acid (Vitamin C): During one exercise study visit, 0.06 g Vit C per kg fat-free mass per 100 ml of normal saline administered; Subjects will receive a bolus of 100mL Vit C solution given at 5ml/min over 20minutes followed by a "drip-infusion" given at 1.7ml/min.
|
|---|---|---|
|
Cardiac disorders
Vasovagal Episodes
|
0.00%
0/20
|
3.7%
1/27
|
|
Musculoskeletal and connective tissue disorders
Minor Exercise Injury
|
0.00%
0/20
|
3.7%
1/27
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place