LipodystrophyLIPOKINESNCT06107439
Impact of Lipodystrophy on the Inflammatory State of Non-diabetic Dunnigan Reunion Island Subjects
A study testing Bood and urine sampling in people with Lipodystrophy and Dunnigan Syndrome, run by Centre Hospitalier Universitaire de la Réunion at 1 site in Reunion.
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. Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Lipodystrophy, Dunnigan Syndrome
- What is being tested?
- Bood and urine sampling
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 64 participants
- Where
- 1 siteReunion
- Study dates
- 14 Aug 2023to 22 Jul 2025
- Phase
- Interventional
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- - 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
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- 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
Trial locations and contacts
1 site in 1 country.
About this study
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
- Being tested
- Bood and urine sampling
- Medical subject headings
- Lipodystrophy, Lipodystrophy, Familial Partial
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Bood and urine samplingBiological
Bood and urine sampling
| Study group | Role | What they receive |
|---|---|---|
| sampling and clinical data collection | Other | Participant blood and urine are sampled for inflammatory signal analysis Receives: Biological: Bood and urine sampling |
What is being measured
The primary outcome is the main question the study is designed to answer.
pro-inflammatory markers
blood sample and dosage of pro inflammatory cytokine
Measured: inclusion day
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted30 Oct 2023
- Study start14 Aug 2023
- Primary completion22 Jul 2025
- Study completion22 Jul 2025
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for LipodystrophyStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Health services research
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 64 participants (actual)
Sponsor and investigators
- Lead sponsor
- Centre Hospitalier Universitaire de la Réunion
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06107439
- Sponsor's protocol ID
- 2021/CHU/12
- Acronym
- LIPOKINES
- Status last verified
- Sep 2026
- First submitted
- 14 Sep 2023
- Last updated
- 16 Sep 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No