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NCT Number: NCT05780775

Lipid Balance in Adult Sickle Cell Patients

This study aims to describe and/or searches for, in cohorts of adult sickle cell anemia (SCA) and SC sickle cell patients living in the French West Indies and followed by SCD Reference and Competence Centers: 1-lipids profiles and associations at steady state with occurrence of sickle cell disease (SCD) complications, 2-lipids profile evolution during and after prospective acute complications (vasoocclusive crises (VOC) and priapism), 3-lipids profile variation (inter /intra individuals) during 4 prospective years, 4- Genetic primary modulators of SCD complications, 5- insulin resistance (HOMA), free fatty acids and glycerol dosages, 6- lipids enzymes, lipidome and functionality of HDL in sub-groups of SCD population.

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Key information

Conditions

Sickle Cell Disease Anemia Anemia, Hemolytic Anemia, Hemolytic, Congenital Anemia, Sickle Cell Complication Congenital, Hereditary, and Neonatal Diseases and Abnormalities Dyslipidemia Dyslipidemias Genetic Diseases, Inborn Genital Diseases Genital Diseases, Male Hematologic Diseases Hemic and Lymphatic Diseases Hemoglobinopathies Hypertension, Pulmonary Lipid Metabolism Disorders Lung Diseases Male Urogenital Diseases Metabolic Diseases Nutritional and Metabolic Diseases Penile Diseases Priapism Pulmonary Arterial Hypertension Respiratory Tract Diseases Urogenital Diseases Vaso-Occlusive Crises

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Unité Transversale de la Drépanocytose

Pointe-à-Pitre, 97159, Guadeloupe

About this study

  • Cohorts of sickle cell disease patients including sickle cell anemia (SCA) and SC sickle cell patients living in Guadeloupe and Martinique and followed by the Sickle cell disease (SCD) Reference and Competence Centers of French West Indies.
  • Lipid profile includes total cholesterol, HDL-cholesterol, non-HDL-cholesterol, LDL-cholesterol and triglycerides, apolipoprotein A-I and B.

Medical histories and prospective collection of SCD complications include retinopathy, deafness, tinnitus, osteonecrosis, leg ulcers, strokes, acute chest syndrome, VOC, priapism, pulmonary arterial hypertension (PAH) and PAH sd (echocardiography diagnosed when tricuspid regurgitant jet velocity ≥2.5 m/sec), kidney disease: chronic renal insufficiency and/or nephropathy.

  • Objective 4: to describe genetic primary modulators of SCD complications: fetal hemoglobin, alpha-thalassemia, haplotypes of beta S gene.
  • Objective 5 will be performed in the entire cohort at inclusion and during prospective complications (VOC, priapism).
  • Objective 6 will be performed in a sub-group of 90 individuals (n=15 with VOC and n= 15 without VOC, n=15 with priapism and n=15 without priapism, n= 15 with pulmonary arterial hypertension syndrome (PAH Sd) and n=15 without PAH Sd), as well as in a subgroup of n = 15 patients prospectively experiencing VOC and n = 15 patients prospectively experiencing priapism.

A collection of plasma is performed to fulfill objective 6, as well as a collection of blood cells for later researches.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • Aged from 18 years and over
  • Be affected with Sickle cell anemia or SC sickle cell
  • Living in French Caribbean Islands of Guadeloupe or Martinique and followed by physicians issued from a French West Indies Sickle Cell Reference or Competence Center
  • At steady state in the last month (without acute complication)
  • To have given a written consent after information on the study.

Exclusion criteria

  • Other hemoglobinopathies than sickle cell disease
  • Pregnancy or lactation
  • Patient under judicial protection or without freedom
  • Patient not affiliated with a social security system
  • Patient hospitalized for transfusion or bleeding in the last 3 months

Treatment and study plan

HDL2

Other

to perform additional blood samples during acute phase of complications (realized between Day 1 and Day 3) in SCD patients hospitalized for vasoocclusive crisis or priapism.

Other names: collection of plasma and of cells.

Primary outcomes

  1. / Lipids profiles at steady state, in sickle cell anemia and SC sickle cell adult patients, classified according to occurrence of complications.

    Time frame: 6 years

    Cohorts of sickle cell disease patients include sickle cell anemia (SCA) and SC sickle cell patients living in Guadeloupe and Martinique and followed by the Sickle cell disease (SCD) Reference and Competence Centers of French West Indies.

    Lipid profile includes total cholesterol, HDL-cholesterol, non-HDL-cholesterol, LDL-cholesterol and triglycerides, apolipoproteins A-I and B.

    Collection of medical histories and of prospective SCD complications include retinopathy, deafness, tinnitus, osteonecrosis, leg ulcers, strokes, acute chest syndrome, VOC, priapism, pulmonary arterial hypertension (PAH) and PAH sd (echocardiography diagnosed when tricuspid regurgitant jet velocity ≥2.5 m/sec), kidney disease: chronic renal insufficiency and/or nephropathy

Secondary outcomes

  1. Kinetic study of lipids profile during hospitalized vasoocclusive crisis (VOC, with or without ACS) and Priapism, at return to steady state at first annual check-up, and one year after this last measurement

    Time frame: 6 years

    Past and prospective collection of previously listed SCD complications

  2. Study of variation of lipid profile, at steady state, during a 4 years period study intra and inter individual levels.

    Time frame: 6 years

    total cholesterol

  3. Study of variation of lipid profile, at steady state, during a 4 years period study intra and inter individual levels.

    Time frame: 6 years

    HDL-cholesterol

  4. Study of variation of lipid profile, at steady state, during a 4 years period study intra and inter individual levels.

    Time frame: 6 years

    non HDL-cholesterol

  5. Study of variation of lipid profile, at steady state, during a 4 years period study intra and inter individual levels.

    Time frame: 6 years

    LDL-cholesterol

  6. Study of variation of lipid profile, at steady state, during a 4 years period study intra and inter individual levels.

    Time frame: 6 years

    triglycerides

  7. Study of variation of lipid profile, at steady state, during a 4 years period study intra and inter individual levels.

    Time frame: 6 years

    Apolipoproteins A-I and B

  8. Description of genetic primary modulators of SCD complications.

    Time frame: 6 years

    Fetal hemoglobin,

  9. Description of genetic primary modulators of SCD complications.

    Time frame: 6 years

    alpha-thalassemia,

  10. Description of genetic primary modulators of SCD complications.

    Time frame: 6 years

    haplotypes of beta S gene

  11. Dosages of Insulin resistance (HOMA),

    Time frame: 6 years

    Plasmatic insulinemia and glycemia (HOMA) will be performed in the entire cohort at inclusion and during prospective complications (VOC, priapism); lipids dosages

  12. free fatty acids

    Time frame: 6 years

    kinetic study of free fatty acids at inclusion and during prospective complications (VOC, priapism);

  13. plasmatic glycerol.

    Time frame: 6 years

    Kinetic study of plasmatic at inclusion and during prospective complications (VOC, priapism);

  14. Dosages of lipids enzymes, lipidome and functionality of HDL at steady state

    Time frame: 6 years

    The dosages of CETP (Cholesteryl Ester Transfer Protein) enzymes activities

  15. Dosages of lipids enzymes, lipidome and functionality of HDL at steady state

    Time frame: 6 years

    The dosages of L-CAT (Lécithine Cholestérol Acyl Transférase) enzymes activities

  16. Dosages of lipids enzymes, lipidome and functionality of HDL at steady state

    Time frame: 6 years

    The dosages of HDL lipidome,

  17. Dosages of lipids enzymes, lipidome and functionality of HDL at steady state

    Time frame: 6 years

    The dosages of HDL functionality,

  18. Dosages of lipids enzymes, lipidome and functionality of HDL at steady state

    Time frame: 6 years

    The dosages of free fatty acid

  19. Dosages of lipids enzymes, lipidome and functionality of HDL at steady state

    Time frame: 6 years

    The dosages of glycerol

Sponsors and collaborators

Lead sponsor

Centre Hospitalier Universitaire de la Guadeloupe

Other

Collaborators

  • Direction Générale de l'Offre de Soins

Registry information

Official study title

Study of Lipid Balance in Adult Sickle Cell SS or SC Patients at Steady State and According to Clinical Phenotypes and During Acute Complications Acronym : "HDL2"

Acronym: HDL2

Important dates

Study start
2022
Primary completion
2027
Study completion
2027
First posted
Mar 23, 2023
Registry last updated
Dec 10, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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