Impact of Lipodystrophy on the Inflammatory State of Non-diabetic Dunnigan Reunion Island Subjects

Not Applicable

Recruiting

• Conditions: Lipodystrophy; Dunnigan Syndrome
• Interventions: Biological: Bood and urine sampling

• Registration Number: NCT06107439
• Lead Sponsor: Centre Hospitalier Universitaire de la Réunion

Brief Summary

Few data and small numbers affect the inflammatory profile of Dunnigan patients. The levels of certain pro-inflammatory biomarkers would be found higher in these subjects compared to control individuals. However, in these studies, several confounding factors were not taken into account such as smoking, an underlying chronic inflammatory disease such as diabetes and could limit the interpretation of the results. There is no other observation of the anti-inflammatory status of these patients.

Detailed Description

Not available

Study Timeline

• Study Start: 2023-08-14
• Status Verified: 2023-09
• Study First Submitted: 2023-09-14
• Study First Submitted QC: 2023-10-27
• Last Update Submitted: 2023-10-27
• Study First Posted: 2023-10-30
• Last Update Posted: 2023-10-30
• Primary Completion: 2024-08-13
• Study Completion: 2025-08-13

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 80

Inclusion Criteria

• Adult subject (>18 years old) affected by partial Dunnigan lipodystrophy in the homozygous or heterozygous state (genetic search for the positive mutation carried out before inclusion in the study).
• Person affiliated to or beneficiary of a social security scheme.
• Free, informed and written consent signed by the participant and the investigator.

Exclusion Criteria

• • Minor
• Persons placed under judicial protection, person participating in another research including a period of exclusion still in progress, severely impaired physical and/or psychological health, which, according to the investigator, may affect the participant's compliance with the study
• Previous known diabetes
• Pregnant woman
• Woman who gave birth less than 6 months ago
• Breastfeeding in progress
• Participation in other research that may have an impact on the evaluation of the main judgment criteria
• Hemoglobin b level < 7 mg/dl or < 9-10 mg/dl for patients with cardiovascular or respiratory pathology.
• Proven inflammatory pathologies
• Anti-inflammatory treatment: taking corticosteroids in the last 3 months.
• Active smoking

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
sampling and clinical data collection	Bood and urine sampling	Participant blood and urine are sampled for inflammatory signal analysis

Primary Outcome Measures

Name	Time	Method
pro-inflammatory markers	inclusion day	blood sample and dosage of pro inflammatory cytokine

Trial Locations

Locations (1)

CHU La Réunion DRCI; 🇷🇪 Saint-Pierre, Réunion