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

October 27, 2023 updated by: Centre Hospitalier Universitaire de la Réunion
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.

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Estimated)

80

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

Yes

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Health Services Research
  • Allocation: N/A
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / 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

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
pro-inflammatory markers
Time Frame: inclusion day
blood sample and dosage of pro inflammatory cytokine
inclusion day

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Centre Hospitalier Universitaire de la Réunion

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

August 14, 2023

Primary Completion (Estimated)

August 13, 2024

Study Completion (Estimated)

August 13, 2025

Study Registration Dates

First Submitted

September 14, 2023

First Submitted That Met QC Criteria

October 27, 2023

First Posted (Actual)

October 30, 2023

Study Record Updates

Last Update Posted (Actual)

October 30, 2023

Last Update Submitted That Met QC Criteria

October 27, 2023

Last Verified

September 1, 2023

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 2021/CHU/12

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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