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

NCT06107439 | Unknown

• 1 other identifier: 2021/CHU/12
• Study Type: interventional
• Target: 80
• Locations: 1 country
• Sites: 1

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.

Conditions

Lipodystrophy; Dunnigan Syndrome

Outcome Measures

Primary Outcomes (1)

• pro-inflammatory markers

  blood sample and dosage of pro inflammatory cytokine

  inclusion day

Study Arms (1)

sampling and clinical data collection

OTHER

Participant blood and urine are sampled for inflammatory signal analysis

Biological: Bood and urine sampling

Interventions

Bood and urine sampling BIOLOGICAL

Bood and urine sampling

sampling and clinical data collection

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Person affiliated to or beneficiary of a social security scheme.
• Free, informed and written consent signed by the participant and the investigator.

You may not qualify if:

• \- Minor
• 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

Sponsors & Collaborators

• Centre Hospitalier Universitaire de la Réunion: lead

Study Sites (1)

CHU La Réunion DRCI

Saint-Pierre, 97400, Reunion

RECRUITING

MeSH Terms

Conditions

Lipodystrophy; Lipodystrophy, Familial Partial

Condition Hierarchy (Ancestors)

Skin Diseases, Metabolic; Skin Diseases; Skin and Connective Tissue Diseases; Lipid Metabolism Disorders; Metabolic Diseases; Nutritional and Metabolic Diseases; Laminopathies; Genetic Diseases, Inborn; Congenital, Hereditary, and Neonatal Diseases and Abnormalities; Lipid Metabolism, Inborn Errors

Study Design

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

Study Record Dates

• First Submitted: September 14, 2023
• First Posted: October 30, 2023
• Study Start: August 14, 2023
• Primary Completion: August 13, 2024
• Study Completion: August 13, 2025
• Last Updated: October 30, 2023

Record last verified: 2023-09

Locations

RE (1)