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RecruitingNCT03449784OBDYSLIPUpdated Jul 5, 2022

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

An observational study in Patient With Dyslipidemia, sponsored by University Hospital, Montpellier. Recruiting at 1 site in France. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2022-07-05.

Sponsored by University Hospital, Montpellier · Observational

Study type
Observational
Model
Cohort
Time perspective
Prospective
Enrollment
977
Ages
18 Years and older
Sex
All
01

Study 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.

02

Conditions studied

  • Patient With Dyslipidemia

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Keywords

  • dyslipidemia
  • lipid-lowering therapy
  • cardiovascular risk
  • diabetes
  • low-density lipoprotein cholesterol
03

Who can participate

Ages eligible
18 Years and older
Sexes eligible
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

Exclusion criteria:

  • Patients with elevated triglycerides (>4.5 mmol/L or >400 mg/dL)
04

Study design

Observational model
Cohort
Time perspective
Prospective
Enrollment
977 participants (estimated)
Patient registry
No

Groups and cohorts

  • patients with dyslipidemia non achieving LDL-C target

    patients with dyslipidemia non achieving LDL-C target

    Other: 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

Interventions

  • OtherDetection of patients with dyslipidemia

    Detection of patients with dyslipidemia

05

What researchers measure

Primary outcomes

  1. number with dyslipidemia

    number of patient with dyslipidemia

    Time frame: 1 day

Secondary outcomes

  1. number of patient not achieving LDL-C target according to cardiovascular risk

    number of patient not achieving LDL-C target according to cardiovascular risk

    Time frame: 1 day

06

Study locations

1 of 1 sites recruiting
  • Uhmontpellier
    Montpellier, 34295, France
    • cyril BREUKER · Contact · c-breuker@chu-montpellier.fr
    • P Goudry · Principal investigator
    • A Avignon · Principal investigator
    • A Sultan · Principal investigator
    • P Cestac · Principal investigator
    • B Sallerin · Principal investigator
    Recruiting
07

References and documents

Publications

  • Breuker C, Clement F, Mura T, Macioce V, Castet-Nicolas A, Audurier Y, Boegner C, Morcrette E, Jalabert A, Villiet M, Avignon A, Sultan A. Non-achievement of LDL-cholesterol targets in patients with diabetes at very-high cardiovascular risk receiving statin treatment: Incidence and risk factors. Int J Cardiol. 2018 Oct 1;268:195-199. doi: 10.1016/j.ijcard.2018.04.068. PubMed 30041785 ↗

Individual participant data

Plan to share: Undecided — NC

08

Registry details

Key details

Study ID
NCT03449784
Lead sponsor
University Hospital, Montpellier
Collaborators
University Hospital, Toulouse
Responsible party
Sponsor
First posted
Feb 28, 2018
Start date
May 1, 2012
Primary completion
Nov 1, 2040 (estimated)
Completion
May 1, 2041 (estimated)
Last update
Jul 5, 2022

Study contacts

Cyril BREUKER, PharmD,Phd
Contact
c-breuker@chu-montpellier.fr
467337121 ext. 33
Cyril BREUKER
principal investigator · University Hospital, Montpellier

Oversight

Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

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