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Clinical Trials/NCT05424913
NCT05424913
Completed
Not Applicable

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

Centre Hospitalier Universitaire de la Réunion1 site in 1 country150 target enrollmentAugust 17, 2021

Overview

Phase
Not Applicable
Intervention
Not specified
Conditions
Lipodystrophy
Sponsor
Centre Hospitalier Universitaire de la Réunion
Enrollment
150
Locations
1
Primary Endpoint
Insulin Regulated Amino Peptidase sérique (IRAPs) levels
Status
Completed
Last Updated
2 years ago

Overview

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).

Registry
clinicaltrials.gov
Start Date
August 17, 2021
End Date
August 16, 2023
Last Updated
2 years ago
Study Type
Interventional
Study Design
Parallel
Sex
All

Investigators

Sponsor
Centre Hospitalier Universitaire de la Réunion
Responsible Party
Sponsor

Eligibility Criteria

Inclusion Criteria

  • Subjects with Dunnigan's Lipodystrophy OR Non-lipodystrophic insulin-resistant subjects OR Insulin-sensitive non-lipodystrophic subjects
  • 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

Outcomes

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 lipidome markers between the 3 categories of participants(at inclusion)
  • Compare levels of inflammation markers between the 3 categories of participants(at inclusion)
  • Compare levels of Insulin Regulated Amino Peptidase sérique (IRAPs) between the 3 categories of participants(at inclusion)

Study Sites (1)

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