Lipid Balance in Adult Sickle Cell Patients (HDL2)

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"

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.

Study Overview

• Status: Active, not recruiting
• Conditions: Dyslipidemia; Sickle Cell Disease; Complication
• Intervention / Treatment: Other: HDL2

Detailed Description

• 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.

• Study Type: Interventional
• Enrollment (Actual): 116
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Guadeloupe
  • Pointe-à-Pitre, Guadeloupe, 97159
    • Unité Transversale de la Drépanocytose

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Basic Science
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Other: HDL 2 follow up; Cohort of adult sickle cell anemia (SCA) and SC sickle cell patients living in Guadeloupe and followed by SCD Reference and Competence Center of Guadeloupe.	Other: HDL2; 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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
/ Lipids profiles at steady state, in sickle cell anemia and SC sickle cell adult patients, classified according to occurrence of complications.	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	6 years

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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	Past and prospective collection of previously listed SCD complications	6 years
Study of variation of lipid profile, at steady state, during a 4 years period study intra and inter individual levels.	total cholesterol	6 years
Study of variation of lipid profile, at steady state, during a 4 years period study intra and inter individual levels.	HDL-cholesterol	6 years
Study of variation of lipid profile, at steady state, during a 4 years period study intra and inter individual levels.	non HDL-cholesterol	6 years
Study of variation of lipid profile, at steady state, during a 4 years period study intra and inter individual levels.	LDL-cholesterol	6 years
Study of variation of lipid profile, at steady state, during a 4 years period study intra and inter individual levels.	triglycerides	6 years
Study of variation of lipid profile, at steady state, during a 4 years period study intra and inter individual levels.	Apolipoproteins A-I and B	6 years
Description of genetic primary modulators of SCD complications.	Fetal hemoglobin,	6 years
Description of genetic primary modulators of SCD complications.	alpha-thalassemia,	6 years
Description of genetic primary modulators of SCD complications.	haplotypes of beta S gene	6 years
Dosages of Insulin resistance (HOMA),	Plasmatic insulinemia and glycemia (HOMA) will be performed in the entire cohort at inclusion and during prospective complications (VOC, priapism); lipids dosages	6 years
free fatty acids	kinetic study of free fatty acids at inclusion and during prospective complications (VOC, priapism);	6 years
plasmatic glycerol.	Kinetic study of plasmatic at inclusion and during prospective complications (VOC, priapism);	6 years
Dosages of lipids enzymes, lipidome and functionality of HDL at steady state	The dosages of CETP (Cholesteryl Ester Transfer Protein) enzymes activities	6 years
Dosages of lipids enzymes, lipidome and functionality of HDL at steady state	The dosages of L-CAT (Lécithine Cholestérol Acyl Transférase) enzymes activities	6 years
Dosages of lipids enzymes, lipidome and functionality of HDL at steady state	The dosages of HDL lipidome,	6 years
Dosages of lipids enzymes, lipidome and functionality of HDL at steady state	The dosages of HDL functionality,	6 years
Dosages of lipids enzymes, lipidome and functionality of HDL at steady state	The dosages of free fatty acid	6 years
Dosages of lipids enzymes, lipidome and functionality of HDL at steady state	The dosages of glycerol	6 years

Collaborators and Investigators

• Sponsor: Centre Hospitalier Universitaire de la Guadeloupe
• Collaborators: Direction Générale de l'Offre de Soins
• Investigators: Principal Investigator: Marie-Laure LALANNE-MISTRIH, : University Hospital of Guadeloupe - Department of Nutrition

Study record dates

Study Major Dates

• Study Start (Actual): November 30, 2022
• Primary Completion (Estimated): November 30, 2027
• Study Completion (Estimated): November 30, 2027

Study Registration Dates

• First Submitted: December 12, 2022
• First Submitted That Met QC Criteria: March 21, 2023
• First Posted (Actual): March 23, 2023

Study Record Updates

• Last Update Posted (Actual): December 10, 2025
• Last Update Submitted That Met QC Criteria: December 3, 2025
• Last Verified: December 1, 2025

More Information

Terms related to this study

• Keywords: priapism; lipids; Sickle cell disease; pulmonary arterial hypertension; vasoocclusive crisis
• Additional Relevant MeSH Terms: Urogenital Diseases; Genital Diseases; Genital Diseases, Male; Male Urogenital Diseases; Genetic Diseases, Inborn; Metabolic Diseases; Respiratory Tract Diseases; Lung Diseases; Hematologic Diseases; Lipid Metabolism Disorders; Anemia, Hemolytic, Congenital; Anemia, Hemolytic; Anemia; Hemoglobinopathies; Penile Diseases; Hypertension, Pulmonary; Congenital, Hereditary, and Neonatal Diseases and Abnormalities; Nutritional and Metabolic Diseases; Hemic and Lymphatic Diseases; Pulmonary Arterial Hypertension; Anemia, Sickle Cell; Dyslipidemias; Priapism; Vaso-Occlusive Crises; Investigative Techniques; Clinical Laboratory Techniques; Diagnostic Techniques and Procedures; Diagnosis; Cytological Techniques; Cell Physiological Phenomena; Cell Count
• Other Study ID Numbers: PAP_RIPH2_2021/09

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No