ClinicalTrials.gg
CompletedNCT00872456ADHOCUpdated Jul 16, 2020

Associations Between Diabetes Care and Haptoglobin Genotype On outComes

An observational study in Diabetes, Cardiovascular Disease and Myocardial Infarction, sponsored by Clalit Health Services. Completed. Open to participants aged 55 Years and older. Per ClinicalTrials.gov, last updated 2020-07-16.

Sponsored by Clalit Health Services · Observational

Study type
Observational
Model
Cohort
Time perspective
Prospective
Enrollment
3,054
Ages
55 Years and older
Sex
All
01

Study 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.

02

Conditions studied

  • Diabetes
  • Cardiovascular Disease
  • Myocardial Infarction
  • Stroke

Keywords

  • Diabetes Mellitus
  • Cardiovascular Disease
  • Haptoglobin
03

In context

Diabetes Mellitus

8,290 studies on the registry are indexed under Diabetes Mellitus; 1,077 are open to participants now.

This study's enrollment of 3,054 is above the median of 246 across 1,936 observational studies indexed under Diabetes Mellitus.

Browse Diabetes Mellitus studies →

Lead sponsor

Clalit Health Services is the lead sponsor of 44 studies on the registry; none are open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
55 Years and older
Sexes eligible
All
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).

Eligibility criteria

Inclusion Criteria:

  • Diabetic patients
  • 55 years old or older at the time of ICARE initiation.
  • Known haptoglobin genotype
  • Signed for ICARE study and registry
Terms in these criteria, in plain language(1)

Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.

Informed consent

Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.

You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.

05

Study design

Observational model
Cohort
Time perspective
Prospective
Enrollment
3,054 participants (actual)
06

What researchers measure

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.

    Time frame: Data retrived continuously till end of 2015

Secondary outcomes

  1. 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.

    Time frame: Data retrived continuously till end of 2015

  2. 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.

    Time frame: Data retrived continuously till end of 2015

07

Study locations

No study locations are listed for this record.

08

Timeline

Tracking since Sep 25, 2026
Not marked actual or estimatedDates not marked actual or estimated

The record gives a start of Mar 2005, a primary completion of Jul 2020 and a completion of Jul 2020. It does not say whether these dates are actual or estimated.

How these figures are worked out, and which studies are left out of them.

Registered
Mar 30, 2009
First posted
Mar 31, 2009
Start
Mar 2005
Primary completionActual
Jul 15, 2020
CompletionActual
Jul 15, 2020
Last update
Jul 16, 2020
What these dates mean
Start.
When the first participant enrolled; while estimated, when the study expects to open to recruitment.
Primary completion.
When the last participant was examined or treated to collect data for the study's main question, its primary outcome. A study that stopped early gives the date its data collection stopped.
Completion.
When the last participant's last visit took place, for every outcome, secondary ones and side effects included: the end of the study. Often later than primary completion, sometimes the same day.
Actual and Est.
Actual means the registry says the date has happened. Est. (estimated) is a date the sponsor plans or expects. It can still move, and the sponsor is expected to change it to actual once it has passed.
No changes since tracking began. The registry record was last updated on Jul 16, 2020, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
09

Registry details

Key details

Study ID
NCT00872456
Lead sponsor
Clalit Health Services
Responsible party
Uzi Milman (Principal Investigator, Clalit Health Services) — Principal investigator
First posted
Mar 31, 2009
Start date
Mar 2005
Primary completion
Jul 15, 2020
Completion
Jul 15, 2020
Last update
Jul 16, 2020

Study contacts

Uzi Milman, MD
principal investigator · Clalit Health Services, Haifa and Western Galilee District, Haifa, Israel.
Chen Shapira, MD
principal investigator · Carmel Medical Center, Clalit Health Services

Oversight

Data monitoring committee
Yes
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is completed, as verified in Jul 2020. You cannot join it, but the record below documents what was studied.

Follow this study

Get an email when the registry record changes — status, dates, results — or when someone posts here.

Sign in to follow

Discussion

Questions and observations about this study, from anyone following it. Not medical advice, and not a channel to the study team — their contact details are on the registry record.

Sign in to join the discussion. Reading takes no account; posting does. You choose a display name, and a pseudonym is the default.

Nothing here yet. If you are running this trial, taking part in it, or weighing whether to, this is the place to say so.

Start the discussion