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| ID | Type | Description | Link |
|---|---|---|---|
| UL1TR000154 | U.S. NIH Grant/Contract | View source |
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| Name | Class |
|---|---|
| American Diabetes Association | OTHER |
| National Institutes of Health (NIH) | NIH |
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This study will evaluate the effects of impaired blood flow regulation on exercise. It will also determine whether the effects are more important in the heart or in the skeletal muscle tissue during exercise. In addition, this study will decide whether temporarily reversing these problems will improve blood flow control, improve heart and muscle tissue function and help improve exercise capacity in person with type 2 diabetes. This study will do so using two methods: (1) by giving vitamin C intravenously (IV) and (2) a three month exercise training program. Up to 100 subjects will be enrolled in this study.
The investigators have found that persons with type 2 diabetes have an impaired ability to perform exercise even without clinically apparent complications. The reasons for this marked abnormality are unknown but are important as the decreased ability to exercise could contribute to the decreased expenditure of physical activity frequently observed in this population and may potentially constitute an early marker of cardiovascular disease.
The investigators wish to evaluate the effects of impaired blood flow regulation on exercise capacity and whether the effects are more important in the heart or in the skeletal muscle tissue during exercise. In addition, the investigators are determining whether correcting these abnormalities by two methods of improving blood flow regulation (acutely infusing Vitamin C or three months of chronic exercise training) leads to improved blood flow regulation, improved heart and skeletal muscle tissue function and hence to better exercise capacity in person with type 2 diabetes. This information will provide a more mechanistic understanding of causes of abnormal exercise responses observed in person with type 2 diabetes as well as whether and to what degree responses are modifiable. Interventions that reverse the exercise defect may facilitate patient adherence to prescribed physical activity programs and potentially decrease cardiovascular mortality in this large segment of the population.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Ascorbic acid | Experimental | All study subjects have ascorbic acid infusion during one exercise visit as well as a three month exercise training intervention. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Exercise program | Behavioral | Three month exercise program located at the Anschutz Medical Campus at I-225 and Colfax. The program runs three times per week for about an hour each session. Gym is open Monday - Saturday during specific hours (morning, noon, evening). |
| Measure | Description | Time Frame |
|---|---|---|
| Percent Change in Circumferential Strain Before and After Exercise at Baseline, After Vitamin C Infusion, and After Exercise Training | 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. | 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 |
| Ejection Fraction: Percentage of Blood Leaving the Heart Before and After Exercise at Baseline, After a Vitamin C Infusion, and After Exercise Training | Evaluate 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. | 7 months; Measures are made at rest for baseline, at rest for Vitamin C administration, and at rest following the exercise training |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Judith G Regensteiner, PhD | University of Colorado, Denver | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| University of Colorado Denver | Aurora | Colorado | 80045 | United States |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 29456629 | Derived | Scalzo RL, Bauer TA, Harrall K, Moreau K, Ozemek C, Herlache L, McMillin S, Huebschmann AG, Dorosz J, Reusch JEB, Regensteiner JG. Acute vitamin C improves cardiac function, not exercise capacity, in adults with type 2 diabetes. Diabetol Metab Syndr. 2018 Feb 14;10:7. doi: 10.1186/s13098-018-0306-9. eCollection 2018. |
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| ID | Title | Description |
|---|---|---|
| FG000 | 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. |
| FG001 | 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. |
| Title | Milestones | Reasons Not Completed | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
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| ID | Title | Description |
|---|---|---|
| BG000 | 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. |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Mean |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | |||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | Percent Change in Circumferential Strain Before and After Exercise at Baseline, After Vitamin C Infusion, and After Exercise Training | 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. | Posted | Mean | Standard Deviation | percentage of change in length | 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 |
|
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | 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 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. |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Pregnancy | Pregnancy, puerperium and perinatal conditions | Systematic Assessment | A subject informed study staff that she was pregnant and was immediately withdrawn from the study as per exclusion criteria. A negative pregnancy test was recorded at start of study involvement. |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Vasovagal Episodes | Cardiac disorders | Systematic Assessment | Subject had two vasovagal episodes during initial visits. MD present had no concern; cardiologist found no evidence of ischemia on EKG. Another during intervention, upon which subject was withdrawn from study (pending resolution of health issues). |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Judith Regensteiner, PhD | University of Colorado | 303-724-2247 | judy.regensteiner@ucdenver.edu |
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| ID | Term |
|---|---|
| D003924 | Diabetes Mellitus, Type 2 |
| C535900 | Limb-girdle muscular dystrophy, type 2C |
| D003920 | Diabetes Mellitus |
| D009043 | Motor Activity |
| D018761 | Multiple Endocrine Neoplasia Type 1 |
| ID | Term |
|---|---|
| D044882 | Glucose Metabolism Disorders |
| D008659 | Metabolic Diseases |
| D009750 | Nutritional and Metabolic Diseases |
| D004700 | Endocrine System Diseases |
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| ID | Term |
|---|---|
| D055070 | Resistance Training |
| D015444 | Exercise |
| D001205 | Ascorbic Acid |
| ID | Term |
|---|---|
| D005081 | Exercise Therapy |
| D012046 | Rehabilitation |
| D000359 | Aftercare |
| D003266 | Continuity of Patient Care |
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|
| Ascorbic Acid (Vitamin C) | Drug | During one exercise study visit, 0.06 grams of 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. |
|
|
| BG001 | 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 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. |
| BG002 | Total | Total of all reporting groups |
| years |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Race/Ethnicity, Customized | Count of Participants | Participants |
|
| Region of Enrollment | Count of Participants | Participants |
|
| Height (cm) | Mean | Standard Deviation | centimeters |
|
| Weight (kg) | Mean | Standard Deviation | kilograms |
|
| Body Mass Index (BMI) | Mean | Standard Deviation | kg/m^2 |
|
| Body Fat Percentage (%) | Mean | Standard Deviation | percentage |
|
| Glucose (mg/dL) | Mean | Standard Deviation | mg/dL |
|
| Insulin (uIU/mL) | Mean | Standard Deviation | uIU/mL |
|
| Total Cholesterol (mg/dL) | Mean | Standard Deviation | mg/dL |
|
| Triglycerides (mg/dL) | Mean | Standard Deviation | mg/dL |
|
| LDL Cholesterol (mg/dL) | Mean | Standard Deviation | mg/dL |
|
| HDL Cholesterol (mg/dL) | Mean | Standard Deviation | mg/dL |
|
| Hemoglobin A1c | Mean | Standard Deviation | percentage |
|
| Peak VO2 (relative) | Mean | Standard Deviation | mL/kg/min |
|
| Peak VO2 (absolute) | Mean | Standard Deviation | mL/min |
|
| OG001 | Circumferential Strain - 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 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. |
|
|
| Primary | Ejection Fraction: Percentage of Blood Leaving the Heart Before and After Exercise at Baseline, After a Vitamin C Infusion, and After Exercise Training | Evaluate 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. | Posted | Mean | Standard Deviation | percentage of blood leaving the heart | 7 months; Measures are made at rest for baseline, at rest for Vitamin C administration, and at rest following the exercise training |
|
|
|
| 1 |
| 20 |
| 0 |
| 20 |
| EG001 | Ascorbic Acid - T2D | 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. | 1 | 27 | 2 | 27 |
|
| Needle stick | Injury, poisoning and procedural complications | Systematic Assessment | Nursing staff member stuck by participant's used lancet as they were experiencing a feeling of faintness after exercise. Nurse informed HR and visited infectious disease department for testing, all of which was negative. |
|
|
| Minor Exercise Injury | Musculoskeletal and connective tissue disorders | Systematic Assessment | Subject felt pop in L hamstring when on leg curl machine during 7th week of intervention. MD immediately evaluated, advised subject to massage, heat/ice, and take ibuprofen as needed. Next day, no visible swelling, pain substantially reduced. |
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| D001519 | Behavior |
| D009377 | Multiple Endocrine Neoplasia |
| D004701 | Endocrine Gland Neoplasms |
| D009371 | Neoplasms by Site |
| D009369 | Neoplasms |
| D009378 | Neoplasms, Multiple Primary |
| D009386 | Neoplastic Syndromes, Hereditary |
| D030342 | Genetic Diseases, Inborn |
| D009358 | Congenital, Hereditary, and Neonatal Diseases and Abnormalities |
| D005791 |
| Patient Care |
| D013812 | Therapeutics |
| D026741 | Physical Therapy Modalities |
| D064797 | Physical Conditioning, Human |
| D009043 | Motor Activity |
| D009068 | Movement |
| D009142 | Musculoskeletal Physiological Phenomena |
| D055687 | Musculoskeletal and Neural Physiological Phenomena |
| D013400 | Sugar Acids |
| D000144 | Acids, Acyclic |
| D002264 | Carboxylic Acids |
| D009930 | Organic Chemicals |
| D006880 | Hydroxy Acids |
| D002241 | Carbohydrates |
| Post Exercise Training |
|