| Trial ID: | L6731 |
| Source ID: | NCT01113671
|
| Associated Drug: |
Vitamin E (D-Alpha-Tocopheryl Acetate)
|
| Title: |
Type 2 Diabetes Haptoglobin Phenotype and Vitamin E
|
| Acronym: |
IDEAL2
|
| Status: |
COMPLETED
|
| Study Results: |
NO
|
| Results: |
|
| Conditions: |
Diabetes Mellitus Type 2
|
| Interventions: |
DRUG: Vitamin E (d-alpha-tocopheryl acetate)|DRUG: Placebo
|
| Outcome Measures: |
Primary: Reverse Cholesterol transport of the HDL, Reverse Cholesterol transport of the HDL will be assessed using patients' serum samples in a specified in vitro laboratory assay on baseline, after the first treatment and after the second treatment, Vitamin E treatment effect on this molecular marker will be compared between the 3 different Haptoglobin phenotype patients groups., 3 months | Secondary: HDL oxidation, HDL oxidation will be assessed using patients' serum samples in a specified in vitro laboratory assay on baseline, after the first treatment and after the second treatment, Vitamin E treatment effect on this molecular marker will be compared between the 3 different Haptoglobin phenotype patients groups., 3 months|HDL structure, HDL structure will be assessed using patients' serum samples in a specified in vitro laboratory assay on baseline, after the first treatment and after the second treatment, Vitamin E treatment effect on this molecular marker will be compared between the 3 different Haptoglobin phenotype patients groups., 3 months|Serum inflammatory markers, Serum inflammatory markers will be assessed using patients' serum samples in a specified in vitro laboratory assay on baseline, after the first treatment and after the second treatment, Vitamin E treatment effect on these molecular markers will be compared between the 3 different Haptoglobin phenotype patients groups., 3 months
|
| Sponsor/Collaborators: |
Sponsor: Technion, Israel Institute of Technology
|
| Gender: |
ALL
|
| Age: |
ADULT, OLDER_ADULT
|
| Phases: |
PHASE2|PHASE3
|
| Enrollment: |
90
|
| Study Type: |
INTERVENTIONAL
|
| Study Designs: |
Allocation: RANDOMIZED|Intervention Model: CROSSOVER|Masking: QUADRUPLE (PARTICIPANT, CARE_PROVIDER, INVESTIGATOR, OUTCOMES_ASSESSOR)|Primary Purpose: BASIC_SCIENCE
|
| Start Date: |
2009-01
|
| Completion Date: |
2011-01
|
| Results First Posted: |
|
| Last Update Posted: |
2011-01-11
|
| Locations: |
Laboratory of Vascular Medicine, Technion Faculty of Medicine, Haifa, Israel
|
| URL: |
https://clinicaltrials.gov/show/NCT01113671
|
