Ignite Creation Date:
2024-05-05 @ 5:01 PM
Last Modification Date:
2024-10-26 @ 9:26 AM
Study NCT ID:
NCT00362518
Status:
COMPLETED
Last Update Posted:
2024-03-12
First Post:
2006-08-09
Brief Title:
Vitamins C and Vitamin E and Cardiovascular Risk
Sponsor:
University of New Mexico
Organization:
University of New Mexico
Study Overview
Official Title:
Vitamin C and Vitamin E Therapy in Type 2 Diabetes and Cardiovascular Risk
Status:
COMPLETED
Status Verified Date:
2024-03
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
The proposed study will examine the hypothesis that vitamin C and vitamin E given to type 2 diabetic individuals will provide effective anti-inflammatory anti-thrombotic and anti-oxidative atherosclerotic protection when administered at the optimal dose as determined by surrogate markers of inflammation hypercoagulability and oxidation
Detailed Description:
This American Diabetes Association research project is to determine why there are discrepant results between individual studies of Vitamin E and C in both animals and humans compared with the results obtained in large randomized human trials using Vitamin E
Subjects The study will enroll subjects both men and women with type 2 diabetes of at least six months duration An outpatient screening test will utilize the following a complete history and physical examination an EKG a urine hcG only for women of childbearing age and the following blood tests CBC Chem-20 lipid profile hemoglobin A1C and C-peptide stimulation test Subjects will be excluded if they have known vascular disease uncontrolled hypertension 14090 mmHg or marked hyperlipidemia serum low density lipoprotein 41 mmolL or serum triglycerides 78 mmolL Eligible patients must have normal electrocardiogram tracings and normal screening test results described above Other important exclusion criteria are cigarette smoking volunteers taking Coumadin and recent use of antioxidant supplements or aspirin All patients will provide written informed consent before enrollment as approved by the University of New Mexico Human Research Review Committee
Surrogate Markers Based on our preliminary data and the published medical literature it is extremely likely that vitamins C and E will modify all three contributors to atherosclerosis Oxidative stress Hypercoagulability and Inflammation Therefore as shown in the table above we have included standard surrogate markers for all three of these contributors
Specific Aim Determine the optimal oral dose of vitamin C and vitamin E relative to the consumption of an atherogenic high fat supper in type 2 diabetic individuals These data are necessary in order to design prospective clinical trials in which vitamins are given to prevent or delay atherosclerotic events One reason that published clinical trials demonstrate conflicting results may be the different dosages of vitamins that have been utilized In the following study we will utilize our high fat simulated Big Mac meal to assess the beneficial effects of these vitamins on surrogate markers of atherosclerosis Three dosages of vitamins will be utilized in order to determine the optimal dosage
The three dosages to be tested are 1 low dose - vitamin C 250mg vitamin E 200 IU 2 medium dose - vitamin C 500 mg vitamin E 400 IU and 3 high dose - vitamin C 1000mg vitamin E 800 IU The results will be compared to a control meal study in which only placebo hence no vitamins is administered The vitamins will be administered before breakfast on each study day
Subjects The study will enroll subjects both men and women with type 2 diabetes of at least six months duration An outpatient screening test will utilize the following a complete history and physical examination an EKG a urine hcG only for women of childbearing age and the following blood tests CBC Chem-20 lipid profile hemoglobin A1C and C-peptide stimulation test Subjects will be excluded if they have known vascular disease uncontrolled hypertension 14090 mmHg or marked hyperlipidemia serum low density lipoprotein 41 mmolL or serum triglycerides 78 mmolL Eligible patients must have normal electrocardiogram tracings and normal screening test results described above Other important exclusion criteria are cigarette smoking volunteers taking Coumadin and recent use of antioxidant supplements or aspirin All patients will provide written informed consent before enrollment as approved by the University of New Mexico Human Research Review Committee
Surrogate Markers Based on our preliminary data and the published medical literature it is extremely likely that vitamins C and E will modify all three contributors to atherosclerosis Oxidative stress Hypercoagulability and Inflammation Therefore as shown in the table above we have included standard surrogate markers for all three of these contributors
Specific Aim Determine the optimal oral dose of vitamin C and vitamin E relative to the consumption of an atherogenic high fat supper in type 2 diabetic individuals These data are necessary in order to design prospective clinical trials in which vitamins are given to prevent or delay atherosclerotic events One reason that published clinical trials demonstrate conflicting results may be the different dosages of vitamins that have been utilized In the following study we will utilize our high fat simulated Big Mac meal to assess the beneficial effects of these vitamins on surrogate markers of atherosclerosis Three dosages of vitamins will be utilized in order to determine the optimal dosage
The three dosages to be tested are 1 low dose - vitamin C 250mg vitamin E 200 IU 2 medium dose - vitamin C 500 mg vitamin E 400 IU and 3 high dose - vitamin C 1000mg vitamin E 800 IU The results will be compared to a control meal study in which only placebo hence no vitamins is administered The vitamins will be administered before breakfast on each study day
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None
Secondary IDs
| Secondary ID | Type | Domain | Link |
|---|---|---|---|
| 7-04-CR-41 | None | None | None |