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

Lipodystrophy Clinical Trial

— IRAP-DUN 2  

Official 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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT05424913
• Other study ID #: 2017/CHU/07-2021-A00105-36
• Status: Completed
• Phase: N/A
• Start date: August 17, 2021
• Est. completion date: August 16, 2023

Study information

• Verified date: June 2022
• Source: Centre Hospitalier Universitaire de la Réunion
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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).

Recruitment information / eligibility

• Status: Completed
• Enrollment: 150
• Est. completion date: August 16, 2023
• Est. primary completion date: August 16, 2023
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Inflammation
• Insulin Resistance
• Lipodystrophy
• Lipodystrophy, Familial Partial

Intervention

Other:
• research-specific blood sample
blood sample of 50 ml maximum levels of serum Insulin Regulated Amino Peptidase, lipidome markers and inflammation markers

Locations

Country	Name	City	State
Réunion	CHU de la Réunion	Saint-Pierre

Sponsors (1)

Lead Sponsor	Collaborator
Centre Hospitalier Universitaire de la Réunion

Country where clinical trial is conducted

Réunion, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Insulin Regulated Amino Peptidase sérique (IRAPs) levels	Insulin Regulated Amino Peptidase sérique (IRAPs)	at inclusion
Primary	inflammation markers levels	TNF-a (tumor necrosis factors-a), IL-1ß (interleukin-1ß), IL-2, IL-6, IL-18, IFN-? (interferon-?) et MCP-1 (monocyte chemoattractant protein-1), IL-10, IL-4, IL-5	at inclusion
Primary	lipidome markers levels	662 plasma lipid species	at inclusion
Secondary	Compare levels of Insulin Regulated Amino Peptidase sérique (IRAPs) between the 3 categories of participants	Insulin Regulated Amino Peptidase sérique (IRAPs)	at inclusion
Secondary	Compare levels of inflammation markers between the 3 categories of participants	TNF-a (tumor necrosis factors-a), IL-1ß (interleukin-1ß), IL-2, IL-6, IL-18, IFN-? (interferon-?) et MCP-1 (monocyte chemoattractant protein-1), IL-10, IL-4, IL-5	at inclusion
Secondary	Compare levels of lipidome markers between the 3 categories of participants	662 plasma lipid species	at inclusion