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

This study is ongoing, but not recruiting participants.
Sponsor:
Information provided by (Responsible Party):
Uzi Milman, Clalit Health Services
ClinicalTrials.gov Identifier:
NCT00872456
First received: March 30, 2009
Last updated: June 20, 2015
Last verified: June 2015
  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 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 ] [ Designated as safety issue: No ]
    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 ] [ Designated as safety issue: No ]
    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 ] [ Designated as safety issue: No ]
    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 2015
Estimated Primary Completion Date: December 2015 (Final data collection date for primary outcome measure)
  Eligibility

Ages Eligible for Study:   55 Years and older
Genders Eligible for Study:   Both
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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: 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

No publications provided

Responsible Party: Uzi Milman, Principal Investigator, Clalit Health Services
ClinicalTrials.gov Identifier: NCT00872456     History of Changes
Other Study ID Numbers: CMC 08-0090CTIL
Study First Received: March 30, 2009
Last Updated: June 20, 2015
Health Authority: Israel: Ministry of Health

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

Additional relevant MeSH terms:
Cardiovascular Diseases
Myocardial Infarction
Heart Diseases
Myocardial Ischemia
Vascular Diseases

ClinicalTrials.gov processed this record on July 07, 2015