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

• Sponsor: Centre Hospitalier Universitaire de la Réunion (Other)
• Overall Status: Recruiting
• CT.gov ID: NCT06107439
• Collaborator: (none)
• Enrollment: 80
• Location: 1
• Arm: 1
• Anticipated Duration (Months): 24
• Patients Per Site Per Month: 3.3

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
Lipodystrophy; Dunnigan Syndrome	Biological: Bood and urine sampling	N/A

Study Design

• Study Type: Interventional
• Anticipated Enrollment: 80 participants
• Allocation: N/A
• Intervention Model: Single Group Assignment
• Masking: None (Open Label)
• Primary Purpose: Health Services Research
• Official Title: Impact of Lipodystrophy on the Inflammatory State of Non-diabetic Dunnigan Reunion Island Subjects
• Actual Study Start Date: Aug 14, 2023
• Anticipated Primary Completion Date: Aug 13, 2024
• Anticipated Study Completion Date: Aug 13, 2025

Arms and Interventions

Arm	Intervention/Treatment
Other: sampling and clinical data collection Participant blood and urine are sampled for inflammatory signal analysis	Biological: Bood and urine sampling; Bood and urine sampling

Outcome Measures

Primary Outcome Measures

1. pro-inflammatory markers [inclusion day]

   blood sample and dosage of pro inflammatory cytokine

Eligibility Criteria

Criteria

• Ages Eligible for Study: 18 Years and Older
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: Yes

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

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	CHU La Réunion DRCI	Saint-Pierre		Réunion	97400

Sponsors and Collaborators

• Centre Hospitalier Universitaire de la Réunion

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

• Responsible Party: Centre Hospitalier Universitaire de la Réunion
• ClinicalTrials.gov Identifier: NCT06107439
• Other Study ID Numbers: 2021/CHU/12
• First Posted: Oct 30, 2023
• Last Update Posted: Oct 30, 2023
• Last Verified: Sep 1, 2023

• Studies a U.S. FDA-regulated Drug Product: No
• Studies a U.S. FDA-regulated Device Product: No
• Additional relevant MeSH terms: Lipodystrophy, Familial Partial; Lipodystrophy

Study Results

No Results Posted as of Oct 30, 2023