Associations Between Diabetes Care and Haptoglobin Genotype On outComes

NCT ID: NCT00872456

Last Updated: 2020-07-16

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Total Enrollment

3054 participants

Study Classification

OBSERVATIONAL

Study Start Date

2005-03-31

Study Completion Date

2020-07-15

Brief Summary

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The ADHOC Cohort comprised 3044 DM individuals, treated in 47 CHS primary care clinics, that underwent haptoglobin genotyping between 2 march, 2005 and 26 September 2006. Individuals were eligible for inclusion if they had DM and were 55 years of age or older. All treatment decisions, regarding all aspects of care and follow-up of the study participants, remained at the discretion of the individual's primary care physician, who was blinded to the individual's Hp type. Hp distribution was: Hp 1-1 285 (9.4%); Hp 2-1 1248 (41.0%); Hp 2-2 1511 (49.6%).

Hypothesis: strict glucose control (HbA1c\<7%) reduces the rate of cardiovascular events only to diabetic patients with the Hp 2-2 phenotype. We also postulated that, since Hp 2-2 DM individuals are at an increased genetic susceptibility for cardiovascular disease (CVD), this unique cohort merits an investigation on the associations between various CVD risk variables and CVD events and establish whether any evident association was dependent of the individual's Hp type.

Detailed Description

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Conditions

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Diabetes Cardiovascular Disease Myocardial Infarction Stroke

Study Design

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Observational Model Type

COHORT

Study Time Perspective

PROSPECTIVE

Eligibility Criteria

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Inclusion Criteria

* Diabetic patients
* 55 years old or older at the time of ICARE initiation.
* Known haptoglobin genotype
* Signed informed consent for ICARE study and registry
Minimum Eligible Age

55 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Clalit Health Services

OTHER

Sponsor Role lead

Responsible Party

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Uzi Milman

Principal Investigator

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Uzi Milman, MD

Role: PRINCIPAL_INVESTIGATOR

Clalit Health Services, Haifa and Western Galilee District, Haifa, Israel.

Chen Shapira, MD

Role: PRINCIPAL_INVESTIGATOR

Carmel Medical Center, Clalit Health Services

Other Identifiers

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CMC 08-0090CTIL

Identifier Type: -

Identifier Source: org_study_id

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