---
title: "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"
nct_id: NCT05424913
overall_status: COMPLETED
phase: NA
sponsor: Centre Hospitalier Universitaire de la Réunion
study_type: INTERVENTIONAL
primary_condition: Lipodystrophy
countries: Reunion
canonical_url: "https://parkinsonspathways.com/agent/trials/NCT05424913.md"
clinicaltrials_gov: "https://clinicaltrials.gov/study/NCT05424913"
ct_last_update_post_date: 2023-10-25
last_seen_at: "2026-05-12T06:54:36.085Z"
source: ClinicalTrials.gov (mirrored, no enrichment)
---
# 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

**NCT ID:** [NCT05424913](https://clinicaltrials.gov/study/NCT05424913)

## Key Facts

- **Status:** COMPLETED
- **Phase:** NA
- **Study Type:** INTERVENTIONAL
- **Target Enrollment:** 150
- **Lead Sponsor:** Centre Hospitalier Universitaire de la Réunion
- **Conditions:** Lipodystrophy, Dunnigan Syndrome
- **Start Date:** 2021-08-17
- **Completion Date:** 2023-08-16
- **CT.gov Last Update:** 2023-10-25

## Brief 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).

## Eligibility

- **Minimum age:** 18 Years
- **Sex:** ALL
- **Healthy Volunteers:** No

```
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:

* Pregnant woman
* Person under guardianship or curators or deprived of liberty
```

## Arms

- **Subjects with Dunnigan's Lipodystrophy** (OTHER)
- **Non-lipodystrophic insulin-resistant subjects** (OTHER)
- **Insulin-sensitive non-lipodystrophic subjects** (OTHER)

## Interventions

- **research-specific blood sample** (OTHER) — blood sample of 50 ml maximum levels of serum Insulin Regulated Amino Peptidase, lipidome markers and inflammation markers

## Primary Outcomes

- **Insulin Regulated Amino Peptidase sérique (IRAPs) levels** _(time frame: at inclusion)_ — Insulin Regulated Amino Peptidase sérique (IRAPs)
- **inflammation markers levels** _(time frame: at inclusion)_ — 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
- **lipidome markers levels** _(time frame: at inclusion)_ — 662 plasma lipid species

## Secondary Outcomes

- **Compare levels of Insulin Regulated Amino Peptidase sérique (IRAPs) between the 3 categories of participants** _(time frame: at inclusion)_
- **Compare levels of inflammation markers between the 3 categories of participants** _(time frame: at inclusion)_
- **Compare levels of lipidome markers between the 3 categories of participants** _(time frame: at inclusion)_

## Locations (1)

- CHU de la Réunion, Saint-Pierre, Reunion

## Recent Field Changes (last 30 days)

- `status.completionDate` — added _(2026-05-12)_
- `status.lastUpdatePostDate` — added _(2026-05-12)_
- `design.phases` — added _(2026-05-12)_
- `design.enrollmentCount` — added _(2026-05-12)_
- `status.overallStatus` — added _(2026-05-12)_
- `status.primaryCompletionDate` — added _(2026-05-12)_
- `eligibility.criteria` — added _(2026-05-12)_
- `eligibility.minAge` — added _(2026-05-12)_
- `eligibility.sex` — added _(2026-05-12)_
- `outcomes.primary` — added _(2026-05-12)_
- `outcomes.secondary` — added _(2026-05-12)_
- `armsInterventions.arms` — added _(2026-05-12)_
- `armsInterventions.interventions` — added _(2026-05-12)_
- `sponsor.lead` — added _(2026-05-12)_
- `results.hasResults` — added _(2026-05-12)_
- `locations.chu de la réunion|saint-pierre||reunion` — added _(2026-05-12)_

---

*Canonical: https://parkinsonspathways.com/agent/trials/NCT05424913.md*  
*Source data (authoritative): https://clinicaltrials.gov/study/NCT05424913*  
*This page is a raw mirror with no AI summary, no editorial enrichment, and no Parkinson's-specific filtering.*