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

Lipodystrophy Clinical Trial

— LIPOKINES  

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT06107439
• Other study ID #: 2021/CHU/12
• Status: Recruiting
• Phase: N/A
• Start date: August 14, 2023
• Est. completion date: August 13, 2025

Study information

• Verified date: September 2023
• Source: Centre Hospitalier Universitaire de la Réunion
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 80
• Est. completion date: August 13, 2025
• Est. primary completion date: August 13, 2024
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Lipodystrophy
• Lipodystrophy, Familial Partial

Intervention

Biological:
• Bood and urine sampling
Bood and urine sampling

Locations

Country	Name	City	State
Réunion	CHU La Réunion DRCI	Saint-Pierre

Sponsors (1)

Lead Sponsor	Collaborator
Centre Hospitalier Universitaire de la Réunion

Country where clinical trial is conducted

Réunion, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	pro-inflammatory markers	blood sample and dosage of pro inflammatory cytokine	inclusion day