search
Back to results

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
Centre Hospitalier Universitaire de la Réunion
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional other trial for Lipodystrophy

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

First Posted
June 3, 2022
Last Updated
October 24, 2023
Sponsor
Centre Hospitalier Universitaire de la Réunion
search

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

We'll reach out to this number within 24 hrs