Lipid Balance in Adult Sickle Cell Patients

NCT05780775 | Active Not Recruiting

• 1 other identifier: PAP_RIPH2_2021/09
• Study Type: interventional
• Target: 116
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Sickle Cell Disease; Dyslipidemia; Complication

Keywords

Sickle cell disease; lipids; vasoocclusive crisis; priapism; pulmonary arterial hypertension

Outcome Measures

Primary Outcomes (1)

• / 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 Outcomes (19)

• 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

  6 years

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

  6 years

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

  6 years

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

  6 years

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

  6 years

Study Arms (1)

HDL 2 follow up

OTHER

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

Interventions

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.

Also known as: collection of plasma and of cells.

HDL 2 follow up

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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

Sponsors & Collaborators

• Centre Hospitalier Universitaire de la Guadeloupe: lead
• Direction Générale de l'Offre de Soins: collaborator

Study Sites (1)

Unité Transversale de la Drépanocytose

Pointe-à-Pitre, 97159, Guadeloupe

Location

MeSH Terms

Conditions

Anemia, Sickle Cell; Dyslipidemias; Vaso-Occlusive Crises; Priapism; Pulmonary Arterial Hypertension

Interventions

Cell Count

Condition Hierarchy (Ancestors)

Anemia, Hemolytic, Congenital; Anemia, Hemolytic; Anemia; Hematologic Diseases; Hemic and Lymphatic Diseases; Hemoglobinopathies; Genetic Diseases, Inborn; Congenital, Hereditary, and Neonatal Diseases and Abnormalities; Lipid Metabolism Disorders; Metabolic Diseases; Nutritional and Metabolic Diseases; Penile Diseases; Genital Diseases, Male; Genital Diseases; Urogenital Diseases; Male Urogenital Diseases; Hypertension, Pulmonary; Lung Diseases; Respiratory Tract Diseases

Intervention Hierarchy (Ancestors)

Cytological Techniques; Clinical Laboratory Techniques; Diagnostic Techniques and Procedures; Diagnosis; Investigative Techniques; Cell Physiological Phenomena

Study Officials

• Marie-Laure LALANNE-MISTRIH

  : University Hospital of Guadeloupe - Department of Nutrition

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: BASIC SCIENCE
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: December 12, 2022
• First Posted: March 23, 2023
• Study Start: November 30, 2022
• Primary Completion (Estimated): November 30, 2027
• Study Completion (Estimated): November 30, 2027
• Last Updated: December 10, 2025

Record last verified: 2025-12

Data Sharing

• IPD Sharing: Will not share

Locations

GU (1)