Associations Between Diabetes Care and Haptoglobin Genotype On outComes

Stroke Clinical Trial

— ADHOC  

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00872456
• Other study ID #: CMC 08-0090CTIL
• Status: Completed
• Start date: March 2005
• Est. completion date: July 15, 2020

Study information

• Verified date: July 2020
• Source: Clalit Health Services
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 3054
• Est. completion date: July 15, 2020
• Est. primary completion date: July 15, 2020
• Accepts healthy volunteers: No
• Gender: All
• Age group: 55 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Cardiovascular Disease
• Cardiovascular Diseases
• Diabetes
• Diabetes Mellitus
• Infarction
• Myocardial Infarction
• Stroke

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Clalit Health Services

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Composite of major CVD events (non fatal MI, Stroke and CVD death)	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.	Data retrived continuously till end of 2015
Secondary	Non cardiovascular death	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.	Data retrived continuously till end of 2015
Secondary	Revascularization procedures	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.	Data retrived continuously till end of 2015