Homburg Cream & Sugar Study (HCS)

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Ulrich Laufs, University Hospital, Saarland
ClinicalTrials.gov Identifier:
NCT00628524
First received: February 25, 2008
Last updated: December 6, 2013
Last verified: December 2013
  Purpose

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.


Condition
Coronary Artery Disease
Diabetes
Metabolic Syndrome
Glucose Tolerance
Hyperlipidemia

Study Type: Observational
Study Design: Observational Model: Cohort
Time Perspective: Prospective
Official Title: Prospective Investigation of the Influence of Triglyceride Tolerance on Cardiovascular Outcomes in Patients With Coronary Artery Disease

Resource links provided by NLM:


Further study details as provided by University Hospital, Saarland:

Primary Outcome Measures:
  • Parameters of triglyceride tolerance and glucose tolerance in correlation to cardiovascular events, cardiovascular mortality, total mortality. [ Time Frame: 48 months after inclusion. ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • 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. ] [ Designated as safety issue: No ]

Biospecimen Retention:   Samples Without DNA

Serum


Enrollment: 514
Study Start Date: February 2008
Study Completion Date: August 2013
Primary Completion Date: July 2013 (Final data collection date for primary outcome measure)
Groups/Cohorts
1
> 500 consecutive patients with coronary artery disease fulfilling eligibility criteria.

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Sampling Method:   Probability Sample
Study Population

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

Criteria

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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00628524

Locations
Germany
University Hospital Homburg / Saar - Cardiology Department
Homburg, Saarland, Germany, 66421
Sponsors and Collaborators
University Hospital, Saarland
Investigators
Principal Investigator: Ulrich Laufs, MD University Hospital, Saarland
  More Information

No publications provided

Responsible Party: Ulrich Laufs, Prof. Dr. Ulrich Laufs, University Hospital, Saarland
ClinicalTrials.gov Identifier: NCT00628524     History of Changes
Other Study ID Numbers: HCS Study
Study First Received: February 25, 2008
Last Updated: December 6, 2013
Health Authority: Germany: Federal Institute for Drugs and Medical Devices

Additional relevant MeSH terms:
Coronary Artery Disease
Myocardial Ischemia
Coronary Disease
Hyperlipidemias
Metabolic Syndrome X
Heart Diseases
Cardiovascular Diseases
Arteriosclerosis
Arterial Occlusive Diseases
Vascular Diseases
Dyslipidemias
Lipid Metabolism Disorders
Metabolic Diseases
Insulin Resistance
Hyperinsulinism
Glucose Metabolism Disorders

ClinicalTrials.gov processed this record on July 24, 2014