DiabetesADHOCNCT00872456
Associations Between Diabetes Care and Haptoglobin Genotype On outComes
An observational study of Diabetes and Cardiovascular Disease, run by Clalit Health Services.
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. Read more about this study
- Who is it for?
- Ages 55 years and older
- Conditions the study is for
- Diabetes, Cardiovascular Disease, Myocardial Infarction
- How many people
- 3,054 participants
- Where
- No sites listed yet
- Study dates
- Mar 2005to 15 Jul 2020
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 55 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Patients recruited from primary care clinics. All are diabetic patients 55 years old or older at the time of ICARE initiation (2005).
Who may be able to join
- Diabetic patients
- 55 years old or older at the time of ICARE initiation.
- Known haptoglobin genotype
- Signed informed consent for ICARE study and registry
Who cannot join
None listed.
About this study
Official title: The ADHOC Project: Associations Between Diabetes Care and Haptoglobin Genotype On outComes
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
- Medical subject headings
- Diabetes Mellitus, Cardiovascular Diseases, Myocardial Infarction, Stroke
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: Data retrived continuously till end of 2015
Secondary outcomes (2)
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.
Measured: Data retrived continuously till end of 2015
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.
Measured: Data retrived continuously till end of 2015
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted31 Mar 2009 (estimated)
- Study startMar 2005
- Primary completion15 Jul 2020
- Study completion15 Jul 2020
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for DiabetesStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 3,054 participants (actual)
Sponsor and investigators
- Lead sponsor
- Clalit Health Services
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Uzi Milman, Clalit Health Services
- Investigators
- 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
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00872456
- Sponsor's protocol ID
- CMC 08-0090CTIL
- Acronym
- ADHOC
- Status last verified
- Jul 2020
- First submitted
- 30 Mar 2009
- Last updated
- 16 Jul 2020
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 16 Jul 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The ADHOC Project: Associations Between Diabetes Care and Haptoglobin Genotype On outComes
- ClinicalTrials.gov ID
- NCT00872456
- Acronym / sponsor ID
- ADHOC / CMC 08-0090CTIL
- Conditions
- Diabetes, Cardiovascular Disease, Myocardial Infarction, Stroke
- Keywords
- Diabetes Mellitus, Cardiovascular Disease, Haptoglobin
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 3,054 participants (actual)
- Lead sponsor
- Clalit Health ServicesUniversity, hospital or other
- Study start
- Mar 2005
- Primary completion
- 15 Jul 2020 (actual)
- Study completion
- 15 Jul 2020 (actual)
- First posted
- 31 Mar 2009 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
Who may qualify
- Ages
- 55 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Patients recruited from primary care clinics. All are diabetic patients 55 years old or older at the time of ICARE initiation (2005).
Key inclusion criteria (4 listed)
- Diabetic patients
- 55 years old or older at the time of ICARE initiation.
- Known haptoglobin genotype
- Signed informed consent for ICARE study and registry
Key exclusion criteria (0 listed)
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Composite of major CVD events (non fatal MI, Stroke and CVD death)
Time frame: Data retrived continuously till end of 2015
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.
2 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
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 16 Jul 2020.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
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
Questions about this trial
What is this clinical trial studying?
An observational study of Diabetes and Cardiovascular Disease, run by Clalit Health Services.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 0 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 16 Jul 2020. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Composite of major CVD events (non fatal MI, Stroke and CVD death) (time frame: Data retrived continuously till end of 2015). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 16 Jul 2020.