Ignite Creation Date:
2024-05-05 @ 10:28 PM
Last Modification Date:
2024-10-26 @ 10:19 AM
Study NCT ID:
NCT01113671
Status:
COMPLETED
Last Update Posted:
2011-01-11
First Post:
2010-04-28
Brief Title:
Type 2 Diabetes Haptoglobin Phenotype and Vitamin E
Sponsor:
Technion Israel Institute of Technology
Organization:
Technion Israel Institute of Technology
Study Overview
Official Title:
Evaluating the Effect of Vitamin E Treatment on HDL Function of Type 2 Diabetic Patients and the Correlation to Hp Phenotype A Prospective Double Blind Randomized Placebo Controlled Trial IDEAL2 Study
Status:
COMPLETED
Status Verified Date:
2011-01
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:
IDEAL2
Brief Summary:
This is a biomarker exploratory study which is designed to investigate the function and oxidation of the high density lipoprotein HDL the good cholesterol in patients with type 2 diabetes mellitus treated with Vitamin E versus placebo and segregated by the type of the Haptoglobin protein they have in their blood
Detailed Description:
There exists ample evidence supporting the hypothesis that vitamin E supplementation to Hp 2-2 DM individuals will reduce the incidence of stroke myocardial infarction and cardiovascular death Data regarding the association between the Hp 1-1 and 2-1 phenotypes and vitamin E treatment on cardiovascular outcomes such as MI stroke and CV death is lacking Furthermore there is no data correlating Hp phenotype vitamin E and HDL function structure and oxidation We wish to evaluate the effect of vitamin E treatment on all diabetic patients with type 2 diabetes on HDL function structure and oxidation and correlate these parameters to Hp phenotype
This study will be the first study to prospectively evaluate the interaction of the Hp phenotype and vitamin E in type 2 diabetic patients As such we wish to evaluate the surrogate marker of reverse cholesterol transport as evidence to the function or dysfunction of the HDL in a relatively small scale study before engaging in a large scale clinical outcome study
Study objectives To evaluate the effect of vitamin E treatment on HDL function of reverse cholesterol transport
Test product Natural Source Vitamin E d-α-tocopherol 400IU administered PO as soft gel capsules
Study population The study population will be comprised of men and women age 55 and above with type 2 DM 90 DM individuals will comprise the treatment phase of the study and will be divided into 30 patients in each Hp phenotype 1-1 2-1 2-2
All 90 patients will be randomized in a double blind fashion into two treatment groups Vitamin E Natural source 400IU per day versus matching placebo assuring that there will be an equal amount of patients of each phenotype allocated to placebo and Vitamin E
Study power Calculation_We have calculated that a sample of a total 90 patient 30 in each phenotype will be required to identify a 30 difference in Reverse Cholesterol Transport between the groups and a statistically significant interaction between phenotype and treatment with an 80 power and a two sided p value of 005
Study administration Eligible patients will be identified using the ICARE study database with the help of the ICARE study coordinator at Clalit Health Services We will identify patients from the 3 Hp phenotypes those patients were Hp typed as part of the ICARE study and their Hp type is on file We will then call the patients and they will be asked questions according to the screening questioner to be identified as eligible according to inclusionexclusion criteria Those eligible will be invited to the Technion faculty of medicine and will be then recruited to the study after they agree and sign the Informed Consent Form ICF Patients will give a blood sample of 50cc of blood at enrollment which will serve as baseline for testing reverse cholesterol transport as well as HDL structure and oxidation Patients will then be randomized to vitamin E or placebo in a double blinded manner We will recruit consecutive eligible patients from the ICARE registry till we reach the number of 30 patients in each phenotype and a total of 90 patients For all 90 treated patients Blood tests 50cc of blood will be performed after 3 months of treatment then cross over for an additional 3 months of treatment which in its end the last blood test will be performed again 50cc Patients who participate in the treatment phase of the study will have to arrive at the clinic 3 times baseline and randomization visit end of first treatment visit and end of second treatment visit
Analysis Reverse cholesterol transport results will be compared within and between the groups using paired and unpaired students t-tests as appropriate The p for interaction between the 3 phenotype groups and treatment will also be determined
This study will be the first study to prospectively evaluate the interaction of the Hp phenotype and vitamin E in type 2 diabetic patients As such we wish to evaluate the surrogate marker of reverse cholesterol transport as evidence to the function or dysfunction of the HDL in a relatively small scale study before engaging in a large scale clinical outcome study
Study objectives To evaluate the effect of vitamin E treatment on HDL function of reverse cholesterol transport
Test product Natural Source Vitamin E d-α-tocopherol 400IU administered PO as soft gel capsules
Study population The study population will be comprised of men and women age 55 and above with type 2 DM 90 DM individuals will comprise the treatment phase of the study and will be divided into 30 patients in each Hp phenotype 1-1 2-1 2-2
All 90 patients will be randomized in a double blind fashion into two treatment groups Vitamin E Natural source 400IU per day versus matching placebo assuring that there will be an equal amount of patients of each phenotype allocated to placebo and Vitamin E
Study power Calculation_We have calculated that a sample of a total 90 patient 30 in each phenotype will be required to identify a 30 difference in Reverse Cholesterol Transport between the groups and a statistically significant interaction between phenotype and treatment with an 80 power and a two sided p value of 005
Study administration Eligible patients will be identified using the ICARE study database with the help of the ICARE study coordinator at Clalit Health Services We will identify patients from the 3 Hp phenotypes those patients were Hp typed as part of the ICARE study and their Hp type is on file We will then call the patients and they will be asked questions according to the screening questioner to be identified as eligible according to inclusionexclusion criteria Those eligible will be invited to the Technion faculty of medicine and will be then recruited to the study after they agree and sign the Informed Consent Form ICF Patients will give a blood sample of 50cc of blood at enrollment which will serve as baseline for testing reverse cholesterol transport as well as HDL structure and oxidation Patients will then be randomized to vitamin E or placebo in a double blinded manner We will recruit consecutive eligible patients from the ICARE registry till we reach the number of 30 patients in each phenotype and a total of 90 patients For all 90 treated patients Blood tests 50cc of blood will be performed after 3 months of treatment then cross over for an additional 3 months of treatment which in its end the last blood test will be performed again 50cc Patients who participate in the treatment phase of the study will have to arrive at the clinic 3 times baseline and randomization visit end of first treatment visit and end of second treatment visit
Analysis Reverse cholesterol transport results will be compared within and between the groups using paired and unpaired students t-tests as appropriate The p for interaction between the 3 phenotype groups and treatment will also be determined
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