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)
Primary Purpose
Lipodystrophy, Dunnigan Syndrome
Status
Completed
Phase
Not Applicable
Locations
Réunion
Study Type
Interventional
Intervention
research-specific blood sample
Sponsored by
About this trial
This is an interventional other trial for Lipodystrophy
Eligibility Criteria
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
Sites / Locations
- CHU de la Réunion
Arms of the Study
Arm 1
Arm 2
Arm 3
Arm Type
Other
Other
Other
Arm Label
Subjects with Dunnigan's Lipodystrophy
Non-lipodystrophic insulin-resistant subjects
Insulin-sensitive non-lipodystrophic subjects
Arm Description
Outcomes
Primary Outcome Measures
Insulin Regulated Amino Peptidase sérique (IRAPs) levels
Insulin Regulated Amino Peptidase sérique (IRAPs)
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
lipidome markers levels
662 plasma lipid species
Secondary Outcome Measures
Compare levels of Insulin Regulated Amino Peptidase sérique (IRAPs) between the 3 categories of participants
Insulin Regulated Amino Peptidase sérique (IRAPs)
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
Compare levels of lipidome markers between the 3 categories of participants
662 plasma lipid species
Full Information
NCT ID
NCT05424913
First Posted
June 3, 2022
Last Updated
October 24, 2023
Sponsor
Centre Hospitalier Universitaire de la Réunion
1. Study Identification
Unique Protocol Identification Number
NCT05424913
Brief 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
Acronym
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
Study Type
Interventional
2. Study Status
Record Verification Date
June 2022
Overall Recruitment Status
Completed
Study Start Date
August 17, 2021 (Actual)
Primary Completion Date
August 16, 2023 (Actual)
Study Completion Date
August 16, 2023 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Centre Hospitalier Universitaire de la Réunion
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No
5. Study Description
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).
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Lipodystrophy, Dunnigan Syndrome
7. Study Design
Primary Purpose
Other
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Non-Randomized
Enrollment
150 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Subjects with Dunnigan's Lipodystrophy
Arm Type
Other
Arm Title
Non-lipodystrophic insulin-resistant subjects
Arm Type
Other
Arm Title
Insulin-sensitive non-lipodystrophic subjects
Arm Type
Other
Intervention Type
Other
Intervention Name(s)
research-specific blood sample
Intervention Description
blood sample of 50 ml maximum levels of serum Insulin Regulated Amino Peptidase, lipidome markers and inflammation markers
Primary Outcome Measure Information:
Title
Insulin Regulated Amino Peptidase sérique (IRAPs) levels
Description
Insulin Regulated Amino Peptidase sérique (IRAPs)
Time Frame
at inclusion
Title
inflammation markers levels
Description
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
Time Frame
at inclusion
Title
lipidome markers levels
Description
662 plasma lipid species
Time Frame
at inclusion
Secondary Outcome Measure Information:
Title
Compare levels of Insulin Regulated Amino Peptidase sérique (IRAPs) between the 3 categories of participants
Description
Insulin Regulated Amino Peptidase sérique (IRAPs)
Time Frame
at inclusion
Title
Compare levels of inflammation markers between the 3 categories of participants
Description
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
Time Frame
at inclusion
Title
Compare levels of lipidome markers between the 3 categories of participants
Description
662 plasma lipid species
Time Frame
at inclusion
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Facility Information:
Facility Name
CHU de la Réunion
City
Saint-Pierre
ZIP/Postal Code
97448
Country
Réunion
12. IPD Sharing Statement
Plan to Share IPD
No
Learn more about this trial
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
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