Associations Between Diabetes Care and Haptoglobin Genotype On outComes

NCT00872456 | Completed DMC

• 1 other identifier: CMC 08-0090CTIL
• Study Type: observational
• Target: 3,054
• Locations: 0 countries
• Sites: N/A

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.

Conditions

Diabetes; Cardiovascular Disease; Myocardial Infarction; Stroke

Keywords

Diabetes Mellitus; Cardiovascular Disease; Haptoglobin

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (2)

• Non cardiovascular death

  Data retrived continuously till end of 2015

• Revascularization procedures

  Data retrived continuously till end of 2015

Eligibility Criteria

• Age: 55 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• 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).

You may qualify if:

• Diabetic patients
• years old or older at the time of ICARE initiation.
• Known haptoglobin genotype
• Signed informed consent for ICARE study and registry

Sponsors & Collaborators

• Clalit Health Services: lead

MeSH Terms

Conditions

Diabetes Mellitus; Cardiovascular Diseases; Myocardial Infarction; Stroke

Condition Hierarchy (Ancestors)

Glucose Metabolism Disorders; Metabolic Diseases; Nutritional and Metabolic Diseases; Endocrine System Diseases; Myocardial Ischemia; Heart Diseases; Vascular Diseases; Infarction; Ischemia; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Necrosis; Cerebrovascular Disorders; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases

Study Officials

• Uzi Milman, MD

  Clalit Health Services, Haifa and Western Galilee District, Haifa, Israel.

  PRINCIPAL INVESTIGATOR

• Chen Shapira, MD

  Carmel Medical Center, Clalit Health Services

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Study Record Dates

• First Submitted: March 30, 2009
• First Posted: March 31, 2009
• Study Start: March 1, 2005
• Primary Completion: July 15, 2020
• Study Completion: July 15, 2020
• Last Updated: July 16, 2020

Record last verified: 2020-07