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Completed

NCT Number: NCT05424913

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

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).

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Key information

Conditions

Lipodystrophy Congenital, Hereditary, and Neonatal Diseases and Abnormalities Dunnigan Syndrome Genetic Diseases, Inborn Laminopathies Lipid Metabolism Disorders Lipid Metabolism, Inborn Errors Lipodystrophy, Familial Partial Metabolic Diseases Nutritional and Metabolic Diseases Skin Diseases Skin Diseases, Metabolic Skin and Connective Tissue Diseases

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

CHU de la Réunion

Saint-Pierre, 97448, Reunion

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

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

  1. Insulin Regulated Amino Peptidase sérique (IRAPs) levels

    Time frame: at inclusion

    Insulin Regulated Amino Peptidase sérique (IRAPs)

  2. 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

  3. lipidome markers levels

    Time frame: at inclusion

    662 plasma lipid species

Secondary outcomes

  1. Compare levels of Insulin Regulated Amino Peptidase sérique (IRAPs) between the 3 categories of participants

    Time frame: at inclusion

    Insulin Regulated Amino Peptidase sérique (IRAPs)

  2. Compare levels of inflammation markers between the 3 categories of participants

    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

  3. Compare levels of lipidome markers between the 3 categories of participants

    Time frame: at inclusion

    662 plasma lipid species

Sponsors and collaborators

Lead sponsor

Centre Hospitalier Universitaire de la Réunion

Other

Registry information

Acronym: IRAP-DUN 2

Important dates

Study start
2021
Primary completion
2023
Study completion
2023
First posted
Jun 21, 2022
Registry last updated
Oct 25, 2023

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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