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Associations Between Diabetes Care and Haptoglobin Genotype On outComes (ADHOC)

This study is ongoing, but not recruiting participants.
Sponsor:
ClinicalTrials.gov Identifier:
NCT00872456
First Posted: March 31, 2009
Last Update Posted: June 15, 2017
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Information provided by (Responsible Party):
Uzi Milman, Clalit Health Services
  Purpose

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.


Condition
Diabetes Cardiovascular Disease Myocardial Infarction Stroke

Study Type: Observational
Study Design: Observational Model: Cohort
Time Perspective: Prospective
Official Title: The ADHOC Project: Associations Between Diabetes Care and Haptoglobin Genotype On outComes

Further study details as provided by Uzi Milman, Clalit Health Services:

Primary Outcome Measures:
  • Composite of major CVD events (non fatal MI, Stroke and CVD death) [ Time Frame: Data retrived continuously till end of 2015 ]
    Clinical data (eg. BP, weight, smoking, etc) medications use, Lab tests and reports on CVD events will be centrally collected from patient's records and Hospital admission summaries. Admission summaries are retrieved using the computerized systems of Clalit Health Services assuring that whenever a patient in the registry is hospitalized the admission summary is retrieve. An events adjudication committee will assess each event in a blinded fashion to determine the nature of the events.


Secondary Outcome Measures:
  • Non cardiovascular death [ Time Frame: Data retrived continuously till end of 2015 ]
    Clinical data (eg. BP, weight, smoking, etc) medications use, Lab tests and reports on CVD events will be centrally collected from patient's records and Hospital admission summaries. Admission summaries are retrieved using the computerized systems of Clalit Health Services assuring that whenever a patient in the registry is hospitalized the admission summary is retrieve. An events adjudication committee will assess each event in a blinded fashion to determine the nature of the events.

  • Revascularization procedures [ Time Frame: Data retrived continuously till end of 2015 ]
    Clinical data (eg. BP, weight, smoking, etc) medications use, Lab tests and reports on CVD events will be centrally collected from patient's records and Hospital admission summaries. Admission summaries are retrieved using the computerized systems of Clalit Health Services assuring that whenever a patient in the registry is hospitalized the admission summary is retrieve. An events adjudication committee will assess each event in a blinded fashion to determine the nature of the events.


Enrollment: 3054
Study Start Date: March 2005
Estimated Study Completion Date: December 2017
Estimated Primary Completion Date: December 2017 (Final data collection date for primary outcome measure)
  Eligibility

Information from the National Library of Medicine

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Ages Eligible for Study:   55 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Probability Sample
Study Population
Patients recruited from primary care clinics. All are diabetic patients 55 years old or older at the time of ICARE initiation (2005).
Criteria

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
  Contacts and Locations
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00872456


Sponsors and Collaborators
Clalit Health Services
Investigators
Principal Investigator: Uzi Milman, MD Clalit Health Services, Haifa and Western Galilee District, Haifa, Israel.
Principal Investigator: Chen Shapira, MD Carmel Medical Center, Clalit Health Services
  More Information

Responsible Party: Uzi Milman, Principal Investigator, Clalit Health Services
ClinicalTrials.gov Identifier: NCT00872456     History of Changes
Other Study ID Numbers: CMC 08-0090CTIL
First Submitted: March 30, 2009
First Posted: March 31, 2009
Last Update Posted: June 15, 2017
Last Verified: June 2017

Keywords provided by Uzi Milman, Clalit Health Services:
Diabetes Mellitus
Cardiovascular Disease
Haptoglobin

Additional relevant MeSH terms:
Diabetes Mellitus
Infarction
Cardiovascular Diseases
Myocardial Infarction
Glucose Metabolism Disorders
Metabolic Diseases
Endocrine System Diseases
Ischemia
Pathologic Processes
Necrosis
Myocardial Ischemia
Heart Diseases
Vascular Diseases