Coronary Artery DiseaseHCSNCT00628524
Homburg Cream & Sugar Study
An observational study of Coronary Artery Disease and Diabetes, run by Universität des Saarlandes at 1 site in Germany.
Trial summary
The purpose of this study is to prospectivly analyze the correlation of triglyceride tolerance and glucose tolerance with cardiovascular morbidity and mortality in patients with stable coronary artery disease within 18 months and to determine, whether measurement of triglyceride tolerance can discriminate patients at… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Coronary Artery Disease, Diabetes, Metabolic Syndrome
- How many people
- 514 participants
- Where
- 1 siteGermany
- Study dates
- Feb 2008to Aug 2013
- 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: > 500 consecutive patients with stable coronary artery disease being treated in the cardiology department of the university hospital.
Who may be able to join
- Stable CAD
Who cannot join
- Acute Coronary Syndrom
- Relevant Arrhythmias
- Severe valvular heart disease
- Decompensated heart failure
- Severe inflammtory disease (infectious, rheumatoid)
- Metabolic diseases (e.g. thyroid)
Show all 13Show fewer
- Inability to swallow
- Liver or kidney failure
- Lactose intolerance
- Fat intolerance (e.g. chronic pancreatitis, gall stones)
- Malignant Disease
- Psychiatric Diseases (including alcohol / drug abuse)
- Pregnancy
Trial locations and contacts
1 site in 1 country.
Germany1 site
University Hospital Homburg / Saar - Cardiology Department
Homburg, Saarland, 66421
About this study
Official title: Prospective Investigation of the Influence of Triglyceride Tolerance on Cardiovascular Outcomes in Patients With Coronary Artery Disease
The purpose of this study is to prospectivly analyze the correlation of triglyceride tolerance and glucose tolerance with cardiovascular morbidity and mortality in patients with stable coronary artery disease within 18 months and to determine, whether measurement of triglyceride tolerance can discriminate patients at risk for cardiovascular events.
- Medical subject headings
- Coronary Artery Disease, Diabetes Mellitus, Metabolic Syndrome, Hyperlipidemias
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 |
|---|---|---|
| 1 | > 500 consecutive patients with coronary artery disease fulfilling eligibility criteria. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Parameters of triglyceride tolerance and glucose tolerance in correlation to cardiovascular events, cardiovascular mortality, total mortality.
Measured: 48 months after inclusion.
Secondary outcomes (1)
Waist-to-Hip ratio, nutrition protocol, physical activity, non-invasive endothelial function, body fat composition, other biomarkers of lipid and glucose metabolism.
Measured: Directly after inclusion.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted5 Mar 2008 (estimated)
- Study startFeb 2008
- Primary completionJul 2013
- Study completionAug 2013
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (3)Papers the sponsor has linked to this study.
- Other trials for Coronary Artery DiseaseStudies 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
- 514 participants (actual)
Sponsor and investigators
- Lead sponsor
- Universität des Saarlandes
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Ulrich Laufs, MD, Principal investigator, University Hospital, Saarland
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00628524
- Sponsor's protocol ID
- HCS Study
- Acronym
- HCS
- Status last verified
- Dec 2013
- First submitted
- 25 Feb 2008
- Last updated
- 2 Dec 2025
- Results posted
- No
- Data monitoring committee
- No
Publications
Werner C, Filmer A, Fritsch M, Groenewold S, Graber S, Bohm M, Laufs U. Risk prediction with triglycerides in patients with stable coronary disease on statin treatment. Clin Res Cardiol. 2014 Dec;103(12):984-97. doi: 10.1007/s00392-014-0740-0. Epub 2014 Jul 11.
PubMed 25012240Katzmann JL, Werner CM, Stojakovic T, Marz W, Scharnagl H, Laufs U. Apolipoprotein CIII predicts cardiovascular events in patients with coronary artery disease: a prospective observational study. Lipids Health Dis. 2020 May 30;19(1):116. doi: 10.1186/s12944-020-01293-9.
PubMed 32473635Hoffmann MM, Werner C, Bohm M, Laufs U, Winkler K. Association of secreted frizzled-related protein 4 (SFRP4) with type 2 diabetes in patients with stable coronary artery disease. Cardiovasc Diabetol. 2014 Nov 19;13:155. doi: 10.1186/s12933-014-0155-2.
PubMed 25408147
Study at a glance
From the registry record, last updated by the sponsor on 2 Dec 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Prospective Investigation of the Influence of Triglyceride Tolerance on Cardiovascular Outcomes in Patients With Coronary Artery Disease
- ClinicalTrials.gov ID
- NCT00628524
- Acronym / sponsor ID
- HCS / HCS Study
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 514 participants (actual)
- Lead sponsor
- Universität des SaarlandesUniversity, hospital or other
- Study start
- Feb 2008
- Primary completion
- Jul 2013 (actual)
- Study completion
- Aug 2013 (actual)
- First posted
- 5 Mar 2008 (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 purpose of this study is to prospectivly analyze the correlation of triglyceride tolerance and glucose tolerance with cardiovascular morbidity and mortality in patients with stable coronary artery disease within 18 months and to determine, whether measurement of triglyceride tolerance can discriminate patients at risk for cardiovascular events.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| 1 | – | –> 500 consecutive patients with coronary artery disease fulfilling eligibility criteria. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- > 500 consecutive patients with stable coronary artery disease being treated in the cardiology department of the university hospital.
Key inclusion criteria (1 listed)
- Stable CAD
Key exclusion criteria (13 listed)
- Acute Coronary Syndrom
- Relevant Arrhythmias
- Severe valvular heart disease
- Decompensated heart failure
- Severe inflammtory disease (infectious, rheumatoid)
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
Parameters of triglyceride tolerance and glucose tolerance in correlation to cardiovascular events, cardiovascular mortality, total mortality.
Time frame: 48 months after inclusion.
1 secondary outcome
Waist-to-Hip ratio, nutrition protocol, physical activity, non-invasive endothelial function, body fat composition, other biomarkers of lipid and glucose metabolism.
Time frame: Directly after inclusion.
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 2 Dec 2025.
- Results publication: PubMed 25012240Werner C, Filmer A, Fritsch M, Groenewold S, Graber S, Bohm M, Laufs U. Risk prediction with triglycerides in patients with stable coronary disease on statin treatment. Clin Res Cardiol. 2014 Dec;103(12):984-97. doi: 10.1007/s00392-014-0740-0. Epub 2014 Jul 11.
- Derived from this study: PubMed 32473635Katzmann JL, Werner CM, Stojakovic T, Marz W, Scharnagl H, Laufs U. Apolipoprotein CIII predicts cardiovascular events in patients with coronary artery disease: a prospective observational study. Lipids Health Dis. 2020 May 30;19(1):116. doi: 10.1186/s12944-020-01293-9.
- Derived from this study: PubMed 25408147Hoffmann MM, Werner C, Bohm M, Laufs U, Winkler K. Association of secreted frizzled-related protein 4 (SFRP4) with type 2 diabetes in patients with stable coronary artery disease. Cardiovasc Diabetol. 2014 Nov 19;13:155. doi: 10.1186/s12933-014-0155-2.
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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.
Ulrich Laufs, MD principal investigator
University Hospital, Saarland
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 Coronary Artery Disease and Diabetes, run by Universität des Saarlandes at 1 site in Germany.
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 13 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 2 Dec 2025. 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 Germany. 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?
Parameters of triglyceride tolerance and glucose tolerance in correlation to cardiovascular events, cardiovascular mortality, total mortality. (time frame: 48 months after inclusion.). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT00628524, which also lists 3 linked publications.
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 2 Dec 2025.