DiabetesPhase 3NCT00362518
Vitamins C and Vitamin E and Cardiovascular Risk
A Phase 3 study testing Study Arm A, Study Arm B and Study Arm C in people with Diabetes, run by University of New Mexico at 1 site in United States.
Trial 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… Read more about this study
- Who is it for?
- Ages 18 to 75 yearsHealthy volunteers can take part
- Conditions the study is for
- Diabetes
- What is being tested?
- Study Arm A, Study Arm B and Study Arm C
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 12 participants
- Where
- 1 siteUnited States
- Study dates
- Jul 2004to Mar 2008
- Phase
- Phase 3
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 75 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- The study will enroll subjects, both men and women with type 2 diabetes of at least six months duration. The age of enrolled subjects will range from 21-60 years old. An HbA1c blood test must show that the person's diabetes is under control. Eligible subjects must have normal electrocardiogram tracings and normal hematological, electrolyte and liver laboratory results at screening. Females of childbearing age must agree to use an effective form of birth control throughout the study period.
Who cannot join
- Subjects will be excluded if they have known vascular disease, uncontrolled hypertension (>140/90 mmHg), marked hyperlipidemia (serum low density lipoprotein > 4.1 mmol/L or serum triglycerides > 7.8 mmol/L), and a body mass index greater than 40 kg/m2 (range 27-40). Other important exclusion criteria are cigarette smoking, volunteers taking Coumadin, and recent use of antioxidant supplements or aspirin. Females who are pregnant or breastfeeding will be excluded. People cannot participate in this study if they are taking medications (other than antidiabetic medications) which may affect blood sugar.
Trial locations and contacts
1 site in 1 country.
United States1 site
University of New Mexico Health Sciences Center
Albuquerque, New Mexico, 87131
About this study
Official title: Vitamin C and Vitamin E Therapy in Type 2 Diabetes and Cardiovascular Risk
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.
Read the 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 (>140/90 mmHg) or marked hyperlipidemia (serum low density lipoprotein > 4.1 mmol/L or serum triglycerides > 7.8 mmol/L). 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.
- Conditions
- Diabetes
- Being tested
- Study Arm A, Study Arm B, Study Arm C, Study Arm D
- Keywords
- atherosclerosis, vitamin C, vitamin E
- Medical subject headings
- Diabetes Mellitus, Atherosclerosis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Study Arm ADietary supplement
Control: no vitamins (placebo only). This study will provide baseline metabolic and surrogate marker changes that are caused by the high fat meal. Study arms B, C, and D will be statistically compared to this study.
Study Arm BDietary supplement
This study arm will provide information on the response of atherogenic surrogate markers to a high fat supper when a low dosage form of vitamin C is administered (250 mg) and Vitamin E (200 IU).
Study Arm CDietary supplement
This study arm will provide information on the response of atherogenic surrogate markers to a high fat supper when a medium dosage form of vitamin C administered (500 mg)and Vitamin E (400 IU).
Study Arm DDietary supplement
This study arm will provide information on the response of atherogenic surrogate markers to a high fat supper when a high dosage form of vitamin C is administered (1000 mg) and Vitamin E (800 IU).
| Study group | Role | What they receive |
|---|---|---|
| 1 | Placebo comparator | Study Arm A - Control: no vitamins (placebo only). Receives: Dietary Supplement: Study Arm A |
| 2 | Active comparator | Study Arm B - Low Dose: Vitamin C 250 mg, Vitamin E 200 IU Receives: Dietary Supplement: Study Arm B |
| 3 | Active comparator | Study Arm C - Medium Dose: Vitamin C 500 mg, Vitamin E 400 IU Receives: Dietary Supplement: Study Arm C |
| 4 | Active comparator | Study Arm D - High Dose: Vitamin C 1000 mg, Vitamin E 800 IU. Receives: Dietary Supplement: Study Arm D |
What is being measured
The primary outcome is the main question the study is designed to answer.
The goal is to determine the effects of the vitamin C and vitamin E on surrogate markers of atherosclerosis following an atherogenic meal in type 2 diabetes
Measured: 2 months
Secondary outcomes (1)
To determine changes in surrogate markers of atherosclerosis in type 2 diabetes
Measured: 2 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted10 Aug 2006 (estimated)
- Study startJul 2004
- Primary completionJun 2007
- Study completionMar 2008
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for DiabetesStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 3
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- Enrolment
- 12 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of New Mexico
- Sponsor type
- University, hospital or other
- Collaborators
- American Diabetes Association
- Investigators
- David S Schade, M.D., Principal investigator, University of New Mexico School of Medicine
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00362518
- Sponsor's protocol ID
- 04-319
- Other IDs
- 7-04-CR-41
- Status last verified
- Mar 2024
- First submitted
- 9 Aug 2006
- Last updated
- 12 Mar 2024
- Results posted
- No
- Data monitoring committee
- Yes
Publications
Gutierrez AD, de Serna DG, Robinson I, Schade DS. The response of gamma vitamin E to varying dosages of alpha vitamin E plus vitamin C. Metabolism. 2009 Apr;58(4):469-78. doi: 10.1016/j.metabol.2008.11.003.
PubMed 19303966
Study at a glance
From the registry record, last updated by the sponsor on 12 Mar 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Vitamin C and Vitamin E Therapy in Type 2 Diabetes and Cardiovascular Risk
- ClinicalTrials.gov ID
- NCT00362518
- Acronym / sponsor ID
- 04-319
- Conditions
- Diabetes
- Keywords
- atherosclerosis, vitamin C, vitamin E
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 12 participants (actual)
- Lead sponsor
- University of New MexicoUniversity, hospital or other
- Collaborators
- American Diabetes Association
- Study start
- Jul 2004 (actual)
- Primary completion
- Jun 2007 (actual)
- Study completion
- Mar 2008 (actual)
- First posted
- 10 Aug 2006 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 (>140/90 mmHg) or marked hyperlipidemia (serum low density lipoprotein > 4.1 mmol/L or serum triglycerides > 7.8 mmol/L). 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 design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| 1 | Placebo comparator | Dietary Supplement: Study Arm AStudy Arm A - Control: no vitamins (placebo only). |
| 2 | Active comparator | Dietary Supplement: Study Arm BStudy Arm B - Low Dose: Vitamin C 250 mg, Vitamin E 200 IU |
| 3 | Active comparator | Dietary Supplement: Study Arm CStudy Arm C - Medium Dose: Vitamin C 500 mg, Vitamin E 400 IU |
| 4 | Active comparator | Dietary Supplement: Study Arm DStudy Arm D - High Dose: Vitamin C 1000 mg, Vitamin E 800 IU. |
Who may qualify
- Ages
- 18 to 75 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- The study will enroll subjects, both men and women with type 2 diabetes of at least six months duration. The age of enrolled subjects will range from 21-60 years old. An HbA1c blood test must show that the person's diabetes is under control. Eligible subjects must have normal electrocardiogram tracings and normal hematological, electrolyte and liver laboratory results at screening. Females of childbearing age must agree to use an effective form of birth control throughout the study period.
Key exclusion criteria (1 listed)
- Subjects will be excluded if they have known vascular disease, uncontrolled hypertension (>140/90 mmHg), marked hyperlipidemia (serum low density lipoprotein > 4.1 mmol/L or serum triglycerides > 7.8 mmol/L), and a body mass index greater than 40 kg/m2 (range 27-40). Other important exclusion criteria are cigarette smoking, volunteers taking Coumadin, and recent use of antioxidant supplements or aspirin. Females who are pregnant or breastfeeding will be excluded. People cannot participate in this study if they are taking medications (other than antidiabetic medications) which may affect blood sugar.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Study Arm AControl: no vitamins (placebo only). This study will provide baseline metabolic and surrogate marker changes that are caused by the high fat meal. Study arms B, C, and D will be statistically compared to this study. | Dietary supplement | 1 |
| Study Arm BThis study arm will provide information on the response of atherogenic surrogate markers to a high fat supper when a low dosage form of vitamin C is administered (250 mg) and Vitamin E (200 IU). | Dietary supplement | 2 |
| Study Arm CThis study arm will provide information on the response of atherogenic surrogate markers to a high fat supper when a medium dosage form of vitamin C administered (500 mg)and Vitamin E (400 IU). | Dietary supplement | 3 |
| Study Arm DThis study arm will provide information on the response of atherogenic surrogate markers to a high fat supper when a high dosage form of vitamin C is administered (1000 mg) and Vitamin E (800 IU). | Dietary supplement | 4 |
Primary outcome
The goal is to determine the effects of the vitamin C and vitamin E on surrogate markers of atherosclerosis following an atherogenic meal in type 2 diabetes
Time frame: 2 months
1 secondary outcome
To determine changes in surrogate markers of atherosclerosis in type 2 diabetes
Time frame: 2 months
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 12 Mar 2024.
- Derived from this study: PubMed 19303966Gutierrez AD, de Serna DG, Robinson I, Schade DS. The response of gamma vitamin E to varying dosages of alpha vitamin E plus vitamin C. Metabolism. 2009 Apr;58(4):469-78. doi: 10.1016/j.metabol.2008.11.003.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
David S Schade, M.D. principal investigator
University of New Mexico School of Medicine
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing Study Arm A, Study Arm B and Study Arm C in people with Diabetes, run by University of New Mexico at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 12 Mar 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
The goal is to determine the effects of the vitamin C and vitamin E on surrogate markers of atherosclerosis following an atherogenic meal in type 2 diabetes (time frame: 2 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT00362518, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 12 Mar 2024.