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 (IRAP-DUN 2)

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).

Study Overview

• Status: Completed
• Conditions: Lipodystrophy; Dunnigan Syndrome
• Intervention / Treatment: Other: research-specific blood sample

• Study Type: Interventional
• Enrollment (Actual): 150
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Réunion
  • Saint-Pierre, Réunion, 97448
    • CHU de la réunion

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Other
• Allocation: Non-Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

3

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Other: Subjects with Dunnigan's Lipodystrophy	Other: research-specific blood sample; blood sample of 50 ml maximum levels of serum Insulin Regulated Amino Peptidase, lipidome markers and inflammation markers
Other: Non-lipodystrophic insulin-resistant subjects	Other: research-specific blood sample; blood sample of 50 ml maximum levels of serum Insulin Regulated Amino Peptidase, lipidome markers and inflammation markers
Other: Insulin-sensitive non-lipodystrophic subjects	Other: research-specific blood sample; blood sample of 50 ml maximum levels of serum Insulin Regulated Amino Peptidase, lipidome markers and inflammation markers

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Insulin Regulated Amino Peptidase sérique (IRAPs) levels	Insulin Regulated Amino Peptidase sérique (IRAPs)	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	at inclusion
lipidome markers levels	662 plasma lipid species	at inclusion

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Compare levels of Insulin Regulated Amino Peptidase sérique (IRAPs) between the 3 categories of participants	Insulin Regulated Amino Peptidase sérique (IRAPs)	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	at inclusion
Compare levels of lipidome markers between the 3 categories of participants	662 plasma lipid species	at inclusion

Collaborators and Investigators

• Sponsor: Centre Hospitalier Universitaire de la Réunion

Study record dates

Study Major Dates

• Study Start (Actual): August 17, 2021
• Primary Completion (Actual): August 16, 2023
• Study Completion (Actual): August 16, 2023

Study Registration Dates

• First Submitted: June 3, 2022
• First Submitted That Met QC Criteria: June 17, 2022
• First Posted (Actual): June 21, 2022

Study Record Updates

• Last Update Posted (Actual): October 25, 2023
• Last Update Submitted That Met QC Criteria: October 24, 2023
• Last Verified: June 1, 2022

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Pathologic Processes; Glucose Metabolism Disorders; Metabolic Diseases; Skin Diseases; Genetic Diseases, Inborn; Hyperinsulinism; Lipid Metabolism Disorders; Laminopathies; Lipid Metabolism, Inborn Errors; Skin Diseases, Metabolic; Inflammation; Insulin Resistance; Lipodystrophy; Lipodystrophy, Familial Partial
• Other Study ID Numbers: 2017/CHU/07-2021-A00105-36

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No