This trial is active, not recruiting.

Conditions diabetes, cardiovascular disease, myocardial infarction, stroke
Sponsor Clalit Health Services
Start date March 2005
End date December 2016
Trial size 3054 participants
Trial identifier NCT00872456, CMC 08-0090CTIL


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.

United States No locations recruiting
Other Countries No locations recruiting

Study Design

Observational model cohort
Time perspective prospective

Primary Outcomes

Composite of major CVD events (non fatal MI, Stroke and CVD death)
time frame: Data retrived continuously till end of 2015

Secondary Outcomes

Non cardiovascular death
time frame: Data retrived continuously till end of 2015
Revascularization procedures
time frame: Data retrived continuously till end of 2015

Eligibility Criteria

Male or female participants at least 55 years old.

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

Additional Information

Official title The ADHOC Project: Associations Between Diabetes Care and Haptoglobin Genotype On outComes
Principal investigator Uzi Milman, MD
Trial information was received from ClinicalTrials.gov and was last updated in July 2016.
Information provided to ClinicalTrials.gov by Clalit Health Services.