Homburg Cream & Sugar Study (HCS)

December 6, 2013 updated by: Ulrich Laufs, University Hospital, Saarland

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.

Study Overview

Status

Completed

Conditions

Study Type

Observational

Enrollment (Actual)

514

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Germany
    • Saarland
      • Homburg, Saarland, Germany, 66421
        • University Hospital Homburg / Saar - Cardiology Department

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Sampling Method

Probability Sample

Study Population

> 500 consecutive patients with stable coronary artery disease being treated in the cardiology department of the university hospital.

Description

Inclusion Criteria:

  • Stable CAD

Exclusion Criteria:

  • Acute Coronary Syndrom
  • Relevant Arrhythmias
  • Severe valvular heart disease
  • Decompensated heart failure
  • Severe inflammtory disease (infectious, rheumatoid)
  • Metabolic diseases (e.g. thyroid)
  • 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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Cohorts and Interventions

Group / Cohort
1
> 500 consecutive patients with coronary artery disease fulfilling eligibility criteria.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Parameters of triglyceride tolerance and glucose tolerance in correlation to cardiovascular events, cardiovascular mortality, total mortality.
Time Frame: 48 months after inclusion.
48 months after inclusion.

Secondary Outcome Measures

Outcome Measure
Time Frame
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.
Directly after inclusion.

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

University Hospital, Saarland

Investigators

  • Principal Investigator: Ulrich Laufs, MD, University Hospital, Saarland

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

February 1, 2008

Primary Completion (Actual)

July 1, 2013

Study Completion (Actual)

August 1, 2013

Study Registration Dates

First Submitted

February 25, 2008

First Submitted That Met QC Criteria

February 25, 2008

First Posted (Estimate)

March 5, 2008

Study Record Updates

Last Update Posted (Estimate)

December 9, 2013

Last Update Submitted That Met QC Criteria

December 6, 2013

Last Verified

December 1, 2013

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • HCS Study

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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