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Assessment of Compliance With European and French Guidelines for the Management of Dyslipidaemias (OBDYSLIP)

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. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details. Identifier: NCT03449784
Recruitment Status : Recruiting
First Posted : February 28, 2018
Last Update Posted : August 6, 2019
Information provided by (Responsible Party):
University Hospital, Montpellier

Brief Summary:

Cardiovascular disease (CVD) due to atherosclerosis of the arterial vessel wall and to thrombosis is the foremost cause of premature mortality and of disability-adjusted life years in Europe, and is also increasingly common in developing countries. In the European Union, the economic cost of CVD represents annually €192 billion in direct and indirect healthcare costs. The main clinical entities are coronary artery disease (CAD), ischaemic stroke, and peripheral arterial disease (PAD). The causes of these CVDs are multifactorial. Some of these factors relate to lifestyles, such as tobacco smoking, lack of physical activity, and dietary habits, and are thus modifiable. Other risk factors are also modifiable, such as elevated blood pressure, type 2 diabetes, and dyslipidaemias, or non-modifiable, such as age and male gender. LDL-cholesterol (LDL-C) is one of the major risk factors for CVD, through its role in the development of atherosclerosis. The efficacy of statins has been demonstrated by a considerable amount of literature not only in lowering LDL cholesterol levels but also in reducing cardiovascular events, both in diabetes and non-diabetes patients. Guidelines for the management of dyslipidemia have emerged from different countries. Thereby, in 2016 the French Society of Endocrinology (SFE) and the New French Society of Atherosclerosis (NSFA) published a consensus statement on the management of dyslipidemias integrating features from European recommendations and in 2017 the Haute Autorité de Santé updated the French guidelines. However, LDL-C goal attainment has rarely been assessed specifically in diabetes population, in which CVD is of particular importance. This study aimed to assess the rate of dyslipidaemias in a population of patient hospitalized in Endocrinology-Diabetology-Nutrition unit.

This observational study was carried in the Diabetes-Nutrition unit of the University Hospital of Montpellier - France. All consecutive patients admitted to that unit during the study period were assessed for eligibility. Data on age, sex, tobacco smoking, body mass index, hypertension (treatment of previously diagnosed hypertension or blood values > 140/90 mmHg), presence and type of CVD (coronary artery disease, stroke and transient ischemic attack, peripheral arterial disease), were collected at admission. LDL-C, HDL-C and triglycerides levels calculated with the Friedewald formula, and glomerular filtration rate calculated according to the CKD-EPI formula were obtained from blood samples taken within 24 hours of hospitalization admission. Information on the name and daily dose of lipid lowering drugs (statins, fibrate, ezetimibe …) at admission was documented. Cardiovascular risk level and LDL-C target values were defined according to 2011 and 2016 ESC guidelines and 2017 French guidelines.

Condition or disease Intervention/treatment
Patient With Dyslipidemia Other: Detection of patients with dyslipidemia

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Study Type : Observational
Estimated Enrollment : 977 participants
Observational Model: Cohort
Time Perspective: Prospective
Official Title: Observatory of Patients With Dyslipidemia Hospitalized in Endocrinology-Diabetology-Nutrition Unit: Observational Study
Actual Study Start Date : May 1, 2012
Estimated Primary Completion Date : November 1, 2040
Estimated Study Completion Date : May 1, 2041

Group/Cohort Intervention/treatment
patients with dyslipidemia non achieving LDL-C target
patients with dyslipidemia non achieving LDL-C target
Other: Detection of patients with dyslipidemia
Detection of patients with dyslipidemia

patients with dyslipidemia achieving LDL-C target
patients with dyslipidemia achieving LDL-C target
Other: Detection of patients with dyslipidemia
Detection of patients with dyslipidemia

Primary Outcome Measures :
  1. number with dyslipidemia [ Time Frame: 1 day ]
    number of patient with dyslipidemia

Secondary Outcome Measures :
  1. number of patient not achieving LDL-C target according to cardiovascular risk [ Time Frame: 1 day ]
    number of patient not achieving LDL-C target according to cardiovascular risk

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population
Study population was composed of patient hospitalized in Diabetes-Nutrition unit of Montpellier University hospital.

Inclusion criteria:

- Patients aged above 18 years old, admitted to the department during the study period and hospitalized for at least 24 hours, blood samples taken within 24 hours of hospitalization admission (LDL-C, triglycerides)

Exclusion criteria:

- Patients with elevated triglycerides (>4.5 mmol/L or >400 mg/dL)

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 identifier (NCT number): NCT03449784

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Contact: Cyril BREUKER, PharmD,Phd 467337121 ext 33

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Uhmontpellier Recruiting
Montpellier, France, 34295
Contact: cyril BREUKER   
Sponsors and Collaborators
University Hospital, Montpellier
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Principal Investigator: Cyril BREUKER University Hospital, Montpellier

Publications automatically indexed to this study by Identifier (NCT Number):
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Responsible Party: University Hospital, Montpellier Identifier: NCT03449784     History of Changes
Other Study ID Numbers: RECHMPL18_0104
First Posted: February 28, 2018    Key Record Dates
Last Update Posted: August 6, 2019
Last Verified: April 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Undecided
Plan Description: NC

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by University Hospital, Montpellier:
lipid-lowering therapy
cardiovascular risk
low-density lipoprotein cholesterol
Additional relevant MeSH terms:
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Lipid Metabolism Disorders
Metabolic Diseases