Impact of Lipodystrophy on the Inflammatory State of Non-diabetic Dunnigan Reunion Island Subjects (NCT06107439) | Clinical Trial Compass
UnknownNot Applicable
Impact of Lipodystrophy on the Inflammatory State of Non-diabetic Dunnigan Reunion Island Subjects
Reunion80 participantsStarted 2023-08-14
Plain-language 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.
Who can participate
Age range
18 Years
Sex
ALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
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
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.
What they're measuring
1
pro-inflammatory markers
Timeframe: inclusion day
Trial details
NCT IDNCT06107439
SponsorCentre Hospitalier Universitaire de la Réunion