Influence of Endothelial Function on Central and Peripheral Causes Of Exercise Impairment in Type… (NCT00786019) | Clinical Trial Compass
CompletedNot Applicable
Influence of Endothelial Function on Central and Peripheral Causes Of Exercise Impairment in Type 2 Diabetes
United States47 participantsStarted 2008-05
Plain-language summary
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.
Who can participate
Age range
30 Years – 55 Years
Sex
ALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
Inclusion Criteria:
* Men and women with uncomplicated Type 2 Diabetes
* Healthy men and women without Type 2 Diabetes
* Patients with Type 2 Diabetes may be taking metformin or sulfonylurea drugs to treat diabetes
* Persons with history of hypercholesteremia if controlled with statins and/or diet
* Patients who are moderately overweight (BMI 25-37.5)
* Must be sedentary (defined as regular exercise \< 2 times a week at a low to moderate level).
* Patients with Hemoglobin A1c (HBA1C) \<8%
* Patients between the ages of 30 to 55 years
* Premenopausal women.
* Former smokers who have quit smoking for at least one year
* Absence of comorbid conditions
* Mild neuropathy is O.K. as long as it will not hamper exercise performance.
* Resting systolic blood pressure (SBP) \< 140, Resting diastolic blood pressure (DBP) \< 90
* Total Cholesterol \< 205 Triglycerides \< 250 low density lipoprotein (LDL) \< 130
* Control subjects with a normal A1C and fasting glucose
Exclusion Criteria:
* People with T2DM taking oral medications, other than metformin or sulfonylurea drugs to control their diabetes.
* Persons treated with insulin will be excluded
* People who are currently smoking or have not quit for at least one year
* Controls who have immediate family history of T2DM
* Peri-menopausal or post-menopausal women.
* Peripheral neuropathy
* Total cholesterol \> 205
* Regional wall motion abnormalities
* LV wall thickness ≥1.1 cm
* Decreased contractility (fractional shortening \<30%)
* …
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.
What they're measuring
1
Percent Change in Circumferential Strain Before and After Exercise at Baseline, After Vitamin C Infusion, and After Exercise Training
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
2
Ejection Fraction: Percentage of Blood Leaving the Heart Before and After Exercise at Baseline, After a Vitamin C Infusion, and After Exercise Training
Timeframe: 7 months; Measures are made at rest for baseline, at rest for Vitamin C administration, and at rest following the exercise training