DiabetesNCT00516204
Diabetic Under 70 (Diabetics Below 70)
An observational study of Diabetes and Hyperlipidemia, run by AstraZeneca at 1 site in Austria.
Trial summary
A screening project of diabetics with a very high cardiovascular risk (e.g. diabetes plus coronary heart disease) who already receive cholesterol-lowering therapy. Lipid profile and rate of patients who are treated to target (which is <70mg/dl for such patients with very high risk) are screened. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Diabetes, Hyperlipidemia, Atherosclerosis
- How many people
- 685 participants
- Where
- 1 siteAustria
- Study dates
- Jul 2007to Dec 2007
- 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 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Male and female secondary prevention patients with: coronary disease with event: acute coronary syndrome, status post MI, PTCA, CABG, angiographically verified), PAVK (min. IIb or S.p. revascularization), stroke/TIA, carotis-plaque (asymptomatic min. 70% or S.p. revascularization), Diabetes Mellitus (type I, II)
Who may be able to join
- Diabetics with hyperlipidemia and atherosclerosis (coronary heart disease, carotid stenosis, PAVK, etc.) who already receive cholesterol-lowering therapy
Who cannot join
- Diabetics w/o CVD; diabetics who do not receive cholesterol-lowering therapy
Trial locations and contacts
1 site in 1 country.
About this study
A screening project of diabetics with a very high cardiovascular risk (e.g. diabetes plus coronary heart disease) who already receive cholesterol-lowering therapy. Lipid profile and rate of patients who are treated to target (which is <70mg/dl for such patients with very high risk) are screened. The doctors therapy decisions after the screening will be documented and 8-10 weeks later the lipid profile of each patient will be evaluated again. Our aim is to evaluate dosing habits, to evaluate how many patients are treated to their LDL-C target and to underline the importance of treating patients to their cholesterol targets.
- Conditions
- Diabetes, Hyperlipidemia, Atherosclerosis
- Keywords
- Hyperlipidemia, Diabetics, NIS, Diabetics with hyperlipidemia and atherosclerosis (coronary heart disease, carotid stenosis, PAVK, etc.)
- Medical subject headings
- Diabetes Mellitus, Hyperlipidemias, Atherosclerosis, Coronary Disease, Carotid Stenosis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| Patients at very high risk | Not described | |
| Patients at high risk | Not described | |
| Patients at medium risk | Not described | |
| Patients at low risk | Not described |
What is being measured
The primary outcome is the main question the study is designed to answer.
Cholesterol levels
Cholesterol levels from high risk patients after 4 weeks of cholesterol-lowering drug therapy under target values
Measured: After 4 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted15 Aug 2007 (estimated)
- Study startJul 2007
- Primary completionDec 2007
- Study completionDec 2007
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.
- More trials run by AstraZenecaThe sponsor's other registered studies.
- 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
- 685 participants (actual)
Sponsor and investigators
- Lead sponsor
- AstraZeneca
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Michael Roden, MD, Study chair, Chairs of the Austrian Diabetes Society
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00516204
- Sponsor's protocol ID
- NIS-CAT-CRE-2007/3
- Other IDs
- NIS-CAT-DUM-2007/3
- Status last verified
- Oct 2014
- First submitted
- 14 Aug 2007
- Last updated
- 30 Oct 2014
- Results posted
- No
Study at a glance
From the registry record, last updated by the sponsor on 30 Oct 2014. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Diabetic Under 70 (Diabetics Below 70)
- ClinicalTrials.gov ID
- NCT00516204
- Acronym / sponsor ID
- NIS-CAT-CRE-2007/3
- Conditions
- Diabetes, Hyperlipidemia, Atherosclerosis
- Keywords
- Hyperlipidemia, Diabetics, NIS, Diabetics with hyperlipidemia and atherosclerosis (coronary heart disease, carotid stenosis, PAVK, etc.)
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 685 participants (actual)
- Lead sponsor
- AstraZenecaIndustry (pharma, biotech, devices)
- Study start
- Jul 2007
- Primary completion
- Dec 2007 (actual)
- Study completion
- Dec 2007 (actual)
- First posted
- 15 Aug 2007 (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.
A screening project of diabetics with a very high cardiovascular risk (e.g. diabetes plus coronary heart disease) who already receive cholesterol-lowering therapy. Lipid profile and rate of patients who are treated to target (which is <70mg/dl for such patients with very high risk) are screened. The doctors therapy decisions after the screening will be documented and 8-10 weeks later the lipid profile of each patient will be evaluated again. Our aim is to evaluate dosing habits, to evaluate how many patients are treated to their LDL-C target and to underline the importance of treating patients to their cholesterol targets.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| Patients at very high risk | – | – |
| Patients at high risk | – | – |
| Patients at medium risk | – | – |
| Patients at low risk | – | – |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Male and female secondary prevention patients with: coronary disease with event: acute coronary syndrome, status post MI, PTCA, CABG, angiographically verified), PAVK (min. IIb or S.p. revascularization), stroke/TIA, carotis-plaque (asymptomatic min. 70% or S.p. revascularization), Diabetes Mellitus (type I, II)
Key inclusion criteria (1 listed)
- Diabetics with hyperlipidemia and atherosclerosis (coronary heart disease, carotid stenosis, PAVK, etc.) who already receive cholesterol-lowering therapy
Key exclusion criteria (1 listed)
- Diabetics w/o CVD; diabetics who do not receive cholesterol-lowering therapy
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
Cholesterol levels
Time frame: After 4 weeks
Cholesterol levels from high risk patients after 4 weeks of cholesterol-lowering drug therapy under target values
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 30 Oct 2014.
Related trials for Diabetes
Recruiting
Clinical Study to Evaluate the Impact of the Accu-Chek SmartGuide CGM Solution on the Mean Change in Time in Range Compared With Self-Monitoring of Blood Glucose in Participants With Type 1 and Type 2 Diabetes Mellitus
Type 1 Diabetes Mellitus, Type 2 Diabetes Mellitus
Not yet recruitingPhase 2
Effects of Meal Macronutrients on Postprandial Lipids
Nephrotic Syndrome, Lipodystrophy
Enrolling by invitation
MTM2MTG Pilot Ancillary Study
Diet, Healthy, HbA1c
Active, not recruitingPhase 3
Compassionate Use of Metreleptin in Previously Treated People With Generalized Lipodystrophy
Lipodystrophy, Diabetes
Active, not recruitingPhase 2
Islet Cell Transplant for Type 1 Diabetes
Type 1 Diabetes Mellitus
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.
Michael Roden, MD study chair
Chairs of the Austrian Diabetes Society
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Diabetes and Hyperlipidemia, run by AstraZeneca at 1 site in Austria.
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 1 inclusion and 1 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 30 Oct 2014. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Austria. Whether a site is taking part right now should be confirmed with that site. See every site.
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?
Cholesterol levels (time frame: After 4 weeks). 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 30 Oct 2014.