Prevention of Cardiovascular Complications in Diabetic Patients With Vitamin E Treatment

NCT00220831 | Terminated Phase 2

• 1 other identifier: KL-2004
• Study Type: interventional
• Target: 2,000
• Locations: 1 country
• Sites: 1

Brief Summary

The purpose of this study is to determine whether Vitamin E treatment to Diabetic patients, who carry the Haptoglobin 2-2 Phenotype, prevents cardiovascular complications such as acute MI and Stroke.

Conditions

Diabetes; Myocardial Infarction; Cardiovascular Disease

Keywords

Diabetes; MI; CVD disease

Outcome Measures

Primary Outcomes (1)

• A combination of CVD mortality non fatal MI and Stoke at a 4 year follow up.

Secondary Outcomes (2)

• Cardiac Interventions (Angioplasty, Bypass surgery

• etc…), all cause mortality, heart failure, at a 4 year follow up.

Interventions

Natural source Vitamin E 400IU/day DRUG

Eligibility Criteria

• Age: 55 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Diabetic patients aged 55 and above

You may not qualify if:

• Patient who takes antioxidant treatment will be asked to stop, or can't be included in the study
• Patients who had a CVD incident (MI, Stroke, TIA), Unstable angina pectoris, Uncontrolled HTN, will have to wait a month after stabilization to be included in the study
• Allergy to Vitamin E

Sponsors & Collaborators

• Technion, Israel Institute of Technology: lead
• Clalit Health Services: collaborator
• The Kennedy Leigh Charitable Trust: collaborator

Study Sites (1)

Clalit Health Services, Haifa and West Galilee - primary health care clinics, in the north of Israel And the Bruce Rappaport Faculty of Medicine, Technion, Haifa, Israel.

Haifa, Israel

Location

Related Publications (9)

• Melamed-Frank M, Lache O, Enav BI, Szafranek T, Levy NS, Ricklis RM, Levy AP. Structure-function analysis of the antioxidant properties of haptoglobin. Blood. 2001 Dec 15;98(13):3693-8. doi: 10.1182/blood.v98.13.3693.

  PMID: 11739174 BACKGROUND

• Levy AP, Roguin A, Hochberg I, Herer P, Marsh S, Nakhoul FM, Skorecki K. Haptoglobin phenotype and vascular complications in patients with diabetes. N Engl J Med. 2000 Sep 28;343(13):969-70. doi: 10.1056/NEJM200009283431313. No abstract available.

  PMID: 11012324 BACKGROUND

• Nakhoul FM, Marsh S, Hochberg I, Leibu R, Miller BP, Levy AP. Haptoglobin genotype as a risk factor for diabetic retinopathy. JAMA. 2000 Sep 13;284(10):1244-5. doi: 10.1001/jama.284.10.1244-a. No abstract available.

  PMID: 10979109 BACKGROUND

• Nakhoul FM, Zoabi R, Kanter Y, Zoabi M, Skorecki K, Hochberg I, Leibu R, Miller B, Levy AP. Haptoglobin phenotype and diabetic nephropathy. Diabetologia. 2001 May;44(5):602-4. doi: 10.1007/s001250051666.

  PMID: 11380078 BACKGROUND

• Roguin A, Hochberg I, Nikolsky E, Markiewicz W, Meisel SR, Hir J, Grenadier E, Beyar R, Levy AP. Haptoglobin phenotype as a predictor of restenosis after percutaneous transluminal coronary angioplasty. Am J Cardiol. 2001 Feb 1;87(3):330-2, A9. doi: 10.1016/s0002-9149(00)01368-0.

  PMID: 11165970 BACKGROUND

• Levy AP, Hochberg I, Jablonski K, Resnick HE, Lee ET, Best L, Howard BV; Strong Heart Study. Haptoglobin phenotype is an independent risk factor for cardiovascular disease in individuals with diabetes: The Strong Heart Study. J Am Coll Cardiol. 2002 Dec 4;40(11):1984-90. doi: 10.1016/s0735-1097(02)02534-2.

  PMID: 12475459 BACKGROUND

• Hochberg I, Roguin A, Nikolsky E, Chanderashekhar PV, Cohen S, Levy AP. Haptoglobin phenotype and coronary artery collaterals in diabetic patients. Atherosclerosis. 2002 Apr;161(2):441-6. doi: 10.1016/s0021-9150(01)00657-8.

  PMID: 11888529 BACKGROUND

• Levy AP, Gerstein HC, Miller-Lotan R, Ratner R, McQueen M, Lonn E, Pogue J. The effect of vitamin E supplementation on cardiovascular risk in diabetic individuals with different haptoglobin phenotypes. Diabetes Care. 2004 Nov;27(11):2767. doi: 10.2337/diacare.27.11.2767. No abstract available.

  PMID: 15505023 BACKGROUND

• Milman U, Blum S, Shapira C, Aronson D, Miller-Lotan R, Anbinder Y, Alshiek J, Bennett L, Kostenko M, Landau M, Keidar S, Levy Y, Khemlin A, Radan A, Levy AP. Vitamin E supplementation reduces cardiovascular events in a subgroup of middle-aged individuals with both type 2 diabetes mellitus and the haptoglobin 2-2 genotype: a prospective double-blinded clinical trial. Arterioscler Thromb Vasc Biol. 2008 Feb;28(2):341-7. doi: 10.1161/ATVBAHA.107.153965. Epub 2007 Nov 21.

  PMID: 18032779 DERIVED

MeSH Terms

Conditions

Diabetes Mellitus; Myocardial Infarction; Cardiovascular Diseases

Condition Hierarchy (Ancestors)

Glucose Metabolism Disorders; Metabolic Diseases; Nutritional and Metabolic Diseases; Endocrine System Diseases; Myocardial Ischemia; Heart Diseases; Vascular Diseases; Infarction; Ischemia; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Necrosis

Study Officials

• Uzi Milman, MD

  Clalit Health Services

  PRINCIPAL INVESTIGATOR

• Chen Shapira, MD

  Clalit Health Services

  STUDY CHAIR

• Shany Blum, MD MSc

  Laboratory of Vascular Medicine, the Bruce Rappaport Faculty of Medicine, Technion - Israel Institute of Technology.

  STUDY CHAIR

• Andrew P Levy, MD PhD

  Laboratory of Vascular Medicine, the Bruce Rappaport Faculty of Medicine, Technion - Israel Institute of Technology.

  STUDY CHAIR

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER

Study Record Dates

• First Submitted: September 13, 2005
• First Posted: September 22, 2005
• Study Start: April 1, 2005
• Study Completion: December 1, 2009
• Last Updated: March 1, 2007

Record last verified: 2007-02

Locations

IL (1)