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The Hellenic Postprandial Lipemia Study (HPLS) (HPLS)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT02163044
Recruitment Status : Completed
First Posted : June 13, 2014
Last Update Posted : August 29, 2019
Sponsor:
Information provided by (Responsible Party):
Hellenic College of Treatment of Atherosclerosis

Brief Summary:
Coronary heart disease (CHD) is the leading cause of death worldwide. The disease is characterized by a high mortality rate (about 40%) and a course continuously altered by lifestyle, gene polymorphisms and therapeutic treatment. Fasting concentration of blood lipids and lipoproteins only partially express the complex relation between dyslipidemia and CHD. Following the indication stated nearly 40 years ago by Zilversmit, there is now accumulating evidence that postprandial lipemia plays an important role in the atherogenic process [ref Kolovou], particularly that most hours of the day are spent in the postprandial state. Furthermore, the increases in blood glucose and triglycerides (TGs) following meals stimulate oxidative stress, impair endothelial function, and rises the inflammatory factors that lead to atherosclerosis. Previous studies reported on postprandial lipemia in subjects with obesity, metabolic syndrome, diabetes mellitus, elderly, patients with CHD and others. However, currently the estimation of cardiovascular disease risk is based on fasting blood values of triglycerides (TGs) and inflammatory markers. The effect of postprandial atherogenic factors on the initiation and progression of atherosclerosis is actually not known.The Hellenic Postprandial Lipemia Study (HPLS) was designed to study the consequences of postprandial lipemia in CRP as inflammatory marker in high-risk adults. Furthermore, the HPLS study will investigate whether hypolipidemic, hypoglycemic or antihypertensive medication may lessen the exaggerated postprandial lipemia as well as the rest abnormal postprandial metabolism. Finally, the HPLS study is intending to evaluate the influence of gene polymorphisms involved in lipid and glucose metabolism on postprandial lipemia and cardiovascular outcomes.

Condition or disease
Coronary Heart Disease Dyslipidemia

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Study Type : Observational
Actual Enrollment : 580 participants
Observational Model: Other
Time Perspective: Prospective
Official Title: A Study to Assess the Consequences of Postprandial Lipemia in CRP as Inflammatory Marker in High-risk Adults, to Investigate Whether Hypolipidemic, Hypoglycemic or Antihypertensive Medication May Lessen the Exaggerated Postprandial Lipemia and Evaluate the Influence of Gene Polymorphisms Involved in Lipid and Glucose Metabolism on Postprandial Lipemia and Cardiovascular Outcomes.
Actual Study Start Date : September 2014
Actual Primary Completion Date : August 2019
Actual Study Completion Date : August 2019

Group/Cohort
Statin
Patients on statin treatment



Primary Outcome Measures :
  1. Change in CRP levels [ Time Frame: 0,6,12,18,24,30,36 months ]
    To study the consequences of postprandial lipemia in CRP as inflammatory marker in high-risk adults.

  2. Change in exaggerated postprandial lipemia [ Time Frame: 0,3,6,12,18,24,30,36 months ]
    To investigate whether hypolipidemic, hypoglycemic or antihypertensive medication may lessen the exaggerated postprandial lipemia as well as the rest abnormal postprandial metabolism.

  3. Change in Lipotest meal values [ Time Frame: 0,3,6,12,18,24,30,36 months ]
    To study the impact of postprandial lipemia using a novel test (Lipotest meal) that distinguishes very-high and high risk subjects in to two subgroups according to first Lipotest meal: the positive group with TG postprandial ≥220 mg/dl, and the negative group with TG postprandial < 220 mg/dl (Consensus criteria).


Secondary Outcome Measures :
  1. Number of major adverse cardiovascular events [ Time Frame: 0-36 months ]
    To report on major adverse cardiovascular events (MACE: death from cardiovascular causes, non-fatal myocardial infarction and non-fatal stroke) in subjects in the positive and negative group.


Other Outcome Measures:
  1. SCORE prediction model value measurement [ Time Frame: 0 - 36 months ]
    To validate a risk prediction model (SCORE) in order to compare the results from the HPLS study with the results expected to be from the SCORE prediction model.



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Ages Eligible for Study:   18 Years to 90 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population
The study aims to recruit 1200 patients that are characterized either as high risk or very-high risk for Coronary Heart Disease. It is assumed that an equal number of high risk and very high risk patients will be included in the study. Patients will be invited to participate in the study from outpatient clinics in the 14 centers in Athens, Greece.
Criteria

Inclusion Criteria:

  • Male or female patients ≥ 18 years of age,
  • Signed informed consent form
  • Fasting triglycerides (TGs) < 220 mg/dl
  • Liver function tests within normal range
  • No more than mild renal impairment (clearance of creatinine >60 ml/min)
  • features of very high risk
  • documented cardiovascular disease by invasive or non-invasive testing (such as coronary angiography, nuclear imaging, stress echocardiography, carotid plaque on ultrasound)
  • previous myocardial infarction
  • acute coronary syndrome
  • coronary revascularization (percutaneous coronary intervention, coronary artery bypass graft) and other arterial revascularization procedures
  • ischemic stroke
  • peripheral artery disease
  • patients with type 2 diabetes
  • patients with type 1 diabetes with target organ damage
  • calculated 10 year risk SCORE ≥10%] or
  • high risk, markedly elevated single risk factors such as:
  • familial dyslipidemias and severe hypertension
  • calculated SCORE ≥5% and <10%

Exclusion Criteria:

  • history of liver, kidney, pancreas, or gall bladder disease,
  • history of acute coronary syndrome one month prior to entering the study
  • pregnancy
  • presence of any inflammatory disease
  • treatment with medications known to affect TGs metabolism or concentration

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02163044


Locations
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Greece
Onassion Cardiology Hospital
Athens, Greece
Sponsors and Collaborators
Hellenic College of Treatment of Atherosclerosis
Investigators
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Study Director: Genovefa Kolovou, M.D., Ph.D., F.E.S.C., S.F.S.A Onassis Cardiac Surgery of Athens
Publications:

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
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Responsible Party: Hellenic College of Treatment of Atherosclerosis
ClinicalTrials.gov Identifier: NCT02163044    
Other Study ID Numbers: 2014-HPLS-IIS
First Posted: June 13, 2014    Key Record Dates
Last Update Posted: August 29, 2019
Last Verified: August 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No
Additional relevant MeSH terms:
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Heart Diseases
Coronary Disease
Coronary Artery Disease
Myocardial Ischemia
Dyslipidemias
Hyperlipidemias
Cardiovascular Diseases
Lipid Metabolism Disorders
Metabolic Diseases
Vascular Diseases
Arteriosclerosis
Arterial Occlusive Diseases