CompletedNCT05424913IRAP-DUN 2Updated Oct 25, 2023

Exploratory Study of the Relationships Between the Biomarkers of Inflammation, Lipidome and Insulin Resistance and Disorders of Glycemic Regulation in a Cohort of Insulin-resistant Subjects Due to Excess Weight or Dunnigan's Lipodystrophy

An interventional study of research-specific blood sample in Lipodystrophy and Dunnigan Syndrome, sponsored by Centre Hospitalier Universitaire de la Réunion. Completed at 1 site in Réunion. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2023-10-25.

Primary conditionLipodystrophy, Familial PartialRegistry: LipodystrophyReclassifiedWhy we changed it

Registry

Lipodystrophy — the first condition term the registry derived for this study.

ClinicalTrials.gg

Lipodystrophy, Familial Partial

Why

The study's listed conditions name Lipodystrophy, Familial Partial, a narrower term within Lipodystrophy.

Confidence

High: the new condition is named in the study's own listed conditions. Of 351 hand-checked studies reclassified this way, 68% were exactly right and 84% in the right disease family; the registry's first term was right for 5% (measured 2026-10-21). How we classify →

Wrong?

Tell us the study's main condition →

Sponsored by Centre Hospitalier Universitaire de la Réunion · Not applicable, Interventional, and Other

From the registry’s dates

Registered 9 months after the study started (first participant enrolled Aug 2021, registered Jun 2022).

Phase: Not applicable
Study type: Interventional
Enrollment: 150
Allocation: Non-randomized
Ages: 18 Years and older
Sex: All

Study summary

The objective of this work is to identify biomarkers of interest in patients with insulin resistance leading to early disorders of glycemic regulation. For this the investigators want to assay the insulin resistance marker Insulin Regulated Amino Peptidase serique (IRAPs), the plasma lipidome and inflammation markers in 2 populations of insulin-resistant subjects due to Dunnigan's inherited lipodystrophy or overweight/obesity and insulin-sensitive subjects with or without a glycemic regulation disorder objectified during an Oral induced hyperglycemia. The results of the IRAPs, lipidome and inflammation assays will be compared in insulin-resistant subjects, between normoglycemic, prediabetic and diabetic subjects. Correlations will be made between these markers and the deterioration of glycemic regulation as well as with known insulin resistance parameters (HOmeostasis Assessment Model (HOMA), Quantitative Insulin-sensitivity Check Index (QUICKI),Insulin Sensitivity Index (Isi) MATSUDA).

Conditions studied

Lipodystrophy
Dunnigan Syndrome

Browse trials for

Lipodystrophy 139Registry's first term
Lipodystrophy, Familial Partial 20Primary · reclassified

In context

Lipodystrophy, Familial Partial Reclassified

20 studies on the registry are indexed under Lipodystrophy, Familial Partial; 5 are open to participants now.

This study's enrollment of 150 is above the median of 16 across 14 interventional studies indexed under Lipodystrophy, Familial Partial.

Browse Lipodystrophy, Familial Partial studies →

Lead sponsor

Centre Hospitalier Universitaire de la Réunion is the lead sponsor of 141 studies on the registry; 37 are open to participants now.

Browse Centre Hospitalier Universitaire de la Réunion studies →

Compared within Lipodystrophy, Familial Partial, this study's primary condition as ClinicalTrials.gg classifies it; the registry's first condition term is Lipodystrophy. The counts are of registry records indexed under each term, refreshed daily. How we classify →

Who can participate

Ages eligible: 18 Years and older
Sexes eligible: All
Accepts healthy volunteers: No

Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.

Inclusion criteria

Subjects with Dunnigan's Lipodystrophy OR Non-lipodystrophic insulin-resistant subjects OR Insulin-sensitive non-lipodystrophic subjects
major
Subjects benefiting from metabolic exploration in the Endocrinology, Diabetology and Nutrition department of the Reunion University Hospital.
Subject benefiting from an oral glucose tolerance test (OGTT) during his follow-up in the Endocrinology, Diabetology and Nutrition department of the Reunion University Hospital.
Person affiliated or beneficiary of a social security scheme.
Subject having been informed of the study in progress and having given their written consent.

Exclusion criteria

Exclusion Criteria:

Pregnant woman
Person under guardianship or curators or deprived of liberty

Study design

Phase: Not applicable
Primary purpose: Other
Allocation: Non-randomized
Intervention model: Parallel assignment
Masking: None (open label)
Enrollment: 150 participants (actual)

Study arms

Other
Subjects with Dunnigan's Lipodystrophy
Other: research-specific blood sample
Other
Non-lipodystrophic insulin-resistant subjects
Other: research-specific blood sample
Other
Insulin-sensitive non-lipodystrophic subjects
Other: research-specific blood sample

Interventions

Otherresearch-specific blood sample
blood sample of 50 ml maximum levels of serum Insulin Regulated Amino Peptidase, lipidome markers and inflammation markers

What researchers measure

Primary outcomes

Insulin Regulated Amino Peptidase sérique (IRAPs) levels
Insulin Regulated Amino Peptidase sérique (IRAPs)
Time frame: at inclusion
inflammation markers levels
TNF-α (tumor necrosis factors-α), IL-1β (interleukin-1β), IL-2, IL-6, IL-18, IFN-γ (interferon-γ) et MCP-1 (monocyte chemoattractant protein-1), IL-10, IL-4, IL-5
Time frame: at inclusion
lipidome markers levels
662 plasma lipid species
Time frame: at inclusion

Secondary outcomes

Compare levels of Insulin Regulated Amino Peptidase sérique (IRAPs) between the 3 categories of participants
Insulin Regulated Amino Peptidase sérique (IRAPs)
Time frame: at inclusion
Compare levels of inflammation markers between the 3 categories of participants
TNF-α (tumor necrosis factors-α), IL-1β (interleukin-1β), IL-2, IL-6, IL-18, IFN-γ (interferon-γ) et MCP-1 (monocyte chemoattractant protein-1), IL-10, IL-4, IL-5
Time frame: at inclusion
Compare levels of lipidome markers between the 3 categories of participants
662 plasma lipid species
Time frame: at inclusion

Study locations

1 site

CHU de la Réunion
Saint-Pierre, 97448, Réunion

References and documents

Individual participant data

Plan to share: No

No publications or documents are linked to this record.

Timeline

Tracking since Sep 25, 2026

ElapsedEstimatedEstimated, not yet reached

Ran from Aug 2021 to primary completion in Aug 2023, 23 months.

How these figures are worked out, and which studies are left out of them.

Registered: Jun 3, 2022
First posted: Jun 21, 2022
StartActual: Aug 17, 2021
Primary completionActual: Aug 16, 2023
CompletionActual: Aug 16, 2023
Last update: Oct 25, 2023

What these dates mean

Start.: When the first participant enrolled; while estimated, when the study expects to open to recruitment.
Primary completion.: When the last participant was examined or treated to collect data for the study's main question, its primary outcome. A study that stopped early gives the date its data collection stopped.
Completion.: When the last participant's last visit took place, for every outcome, secondary ones and side effects included: the end of the study. Often later than primary completion, sometimes the same day.
Actual and Est.: Actual means the registry says the date has happened. Est. (estimated) is a date the sponsor plans or expects. It can still move, and the sponsor is expected to change it to actual once it has passed.

No changes since tracking began. The registry record was last updated on Oct 25, 2023, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗

Registry details

Key details

Study ID: NCT05424913
Lead sponsor: Centre Hospitalier Universitaire de la Réunion
Responsible party: Sponsor
First posted: Jun 21, 2022
Start date: Aug 17, 2021
Primary completion: Aug 16, 2023
Completion: Aug 16, 2023
Last update: Oct 25, 2023

Oversight

Data monitoring committee: No
FDA-regulated drug: No
FDA-regulated device: No

View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is completed, as verified in Jun 2022. You cannot join it, but the record below documents what was studied.

Follow this study

Get an email when the registry record changes — status, dates, results — or when someone posts here.

Discussion

Questions and observations about this study, from anyone following it. Not medical advice, and not a channel to the study team — their contact details are on the registry record.

Sign in to join the discussion. Reading takes no account; posting does. You choose a display name, and a pseudonym is the default.

Nothing here yet. If you are running this trial, taking part in it, or weighing whether to, this is the place to say so.

Other studies in this condition

Lipodystrophy, Familial Partial →

Other studies from this sponsor

Centre Hospitalier Universitaire de la Réunion →

Start the discussion