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The Effect of a Natural Polyphenolic Extract From Pomegrnate (POMX) on the Development of Atherosclerosis in Diabetic Patients (POMX)

Primary Purpose

Atherosclerosis

Status

Unknown status

Phase

Phase 4

Locations

Israel

Study Type

Interventional

Intervention

POMx

About this trial

This is an interventional treatment trial for Atherosclerosis focused on measuring Minors, Enrollment in another study, Males, HBA1C greater than 7, Drug therapy for DM

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)MaleDoes not accept healthy volunteers

Inclusion Criteria:

Males
HBA1C>7%
Drug therapy given for DM

Exclusion Criteria:

Age<18
Inclusion in another study

Sites / Locations

Ha'Emek Medical Center

Outcomes

Primary Outcome Measures

Secondary Outcome Measures

Full Information

NCT ID

NCT00470808

First Posted

May 7, 2007

Last Updated

May 7, 2007

Sponsor

HaEmek Medical Center, Israel

1. Study Identification

Unique Protocol Identification Number

NCT00470808

Brief Title

The Effect of a Natural Polyphenolic Extract From Pomegrnate (POMX) on the Development of Atherosclerosis in Diabetic Patients

Acronym

POMX

Study Type

Interventional

2. Study Status

Record Verification Date

April 2007

Overall Recruitment Status

Unknown status

Study Start Date

May 2007 (undefined)

Primary Completion Date

undefined (undefined)

Study Completion Date

August 2007 (Anticipated)

3. Sponsor/Collaborators

Name of the Sponsor

HaEmek Medical Center, Israel

4. Oversight

Data Monitoring Committee

5. Study Description

Brief Summary

Diabetes is a highly atherogenic disease. Pomegranate juice has impressive antioxidant properties. It has been proven to decrease oxidant stress and to cause the regression of atherosclerotic plaques in hypercholestrolemic and diabetic patients.Furthermore it has been proven to potentiate the biologic activity of the enzyme paraoxonase 1 which is very important in preventing atherosclerosis. The study will try to prove that a polyphenolic extract from pomegranate (POMx) has the same desired effects.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Atherosclerosis

Keywords

Minors, Enrollment in another study, Males, HBA1C greater than 7, Drug therapy for DM

7. Study Design

Primary Purpose

Treatment

Study Phase

Phase 4

Interventional Study Model

Single Group Assignment

Masking

None (Open Label)

Allocation

Non-Randomized

8. Arms, Groups, and Interventions

Intervention Type

Drug

Intervention Name(s)

POMx

10. Eligibility

Sex

Male

Minimum Age & Unit of Time

18 Years

Accepts Healthy Volunteers

Eligibility Criteria

Inclusion Criteria: Males HBA1C>7% Drug therapy given for DM Exclusion Criteria: Age<18 Inclusion in another study

Central Contact Person:

First Name & Middle Initial & Last Name or Official Title & Degree

Wasseem Rock, MD

Phone

0547866896

wasseem_rock@yahoo.com

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Wasseem Rock, MD

Organizational Affiliation

Ha'Emek Medical Center

Official's Role

Principal Investigator

Facility Information:

Facility Name

Ha'Emek Medical Center

City

Afula

ZIP/Postal Code

18101

Country

Israel

Facility Contact:

First Name & Middle Initial & Last Name & Degree

Wasseem Rock, MD

Phone

0547-866806

First Name & Middle Initial & Last Name & Degree

Wasseem Rock, MD

12. IPD Sharing Statement

Learn more about this trial

The Effect of a Natural Polyphenolic Extract From Pomegrnate (POMX) on the Development of Atherosclerosis in Diabetic Patients

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