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Associations Between Diabetes Care and Haptoglobin Genotype On outComes

The ADHOC Project: Associations Between Diabetes Care and Haptoglobin Genotype On outComes

Status
Completed
Phases
Unknown
Study type
Observational
Source
ClinicalTrials.gov
Registry ID
NCT00872456
Acronym
ADHOC
Enrollment
3054
Registered
2009-03-31
Start date
2005-03-31
Completion date
2020-07-15
Last updated
2020-07-16

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Cardiovascular Disease, Diabetes, Myocardial Infarction, Stroke

Keywords

Diabetes Mellitus, Cardiovascular Disease, Haptoglobin

Brief summary

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.

Interventions

None listed

Sponsors

Clalit Health Services
Lead SponsorOTHER

Study design

Observational model
COHORT
Time perspective
PROSPECTIVE

Eligibility

Sex/Gender
ALL
Age
55 Years to No maximum
Healthy volunteers
No

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

Design outcomes

Primary

MeasureTime frameDescription
Composite of major CVD events (non fatal MI, Stroke and CVD death)Data retrived continuously till end of 2015Clinical 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

MeasureTime frameDescription
Non cardiovascular deathData retrived continuously till end of 2015Clinical 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 proceduresData retrived continuously till end of 2015Clinical 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.

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026