NCT05424913

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).

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
150

participants targeted

Target at P75+ for not_applicable

Timeline
Completed

Started Aug 2021

Typical duration for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

August 17, 2021

Completed
10 months until next milestone

First Submitted

Initial submission to the registry

June 3, 2022

Completed
18 days until next milestone

First Posted

Study publicly available on registry

June 21, 2022

Completed
1.2 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

August 16, 2023

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

August 16, 2023

Completed
Last Updated

October 25, 2023

Status Verified

June 1, 2022

Enrollment Period

2 years

First QC Date

June 3, 2022

Last Update Submit

October 24, 2023

Conditions

LipodystrophyDunnigan Syndrome

Outcome Measures

Primary Outcomes (3)

  • Insulin Regulated Amino Peptidase sérique (IRAPs) levels

    Insulin Regulated Amino Peptidase sérique (IRAPs)

    at inclusion

  • 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

    at inclusion

  • lipidome markers levels

    662 plasma lipid species

    at inclusion

Secondary Outcomes (3)

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

    at inclusion

  • Compare levels of inflammation markers between the 3 categories of participants

    at inclusion

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

    at inclusion

Study Arms (3)

Subjects with Dunnigan's Lipodystrophy

OTHER
Other: research-specific blood sample

Non-lipodystrophic insulin-resistant subjects

OTHER
Other: research-specific blood sample

Insulin-sensitive non-lipodystrophic subjects

OTHER
Other: research-specific blood sample

Interventions

research-specific blood sampleOTHER

blood sample of 50 ml maximum levels of serum Insulin Regulated Amino Peptidase, lipidome markers and inflammation markers

Insulin-sensitive non-lipodystrophic subjectsNon-lipodystrophic insulin-resistant subjectsSubjects with Dunnigan's Lipodystrophy

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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.

You may not qualify if:

  • Pregnant woman
  • Person under guardianship or curators or deprived of liberty

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

CHU de la Réunion

Saint-Pierre, 97448, Reunion

Location

MeSH Terms

Conditions

LipodystrophyLipodystrophy, Familial Partial

Condition Hierarchy (Ancestors)

Skin Diseases, MetabolicSkin DiseasesSkin and Connective Tissue DiseasesLipid Metabolism DisordersMetabolic DiseasesNutritional and Metabolic DiseasesLaminopathiesGenetic Diseases, InbornCongenital, Hereditary, and Neonatal Diseases and AbnormalitiesLipid Metabolism, Inborn Errors

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NON RANDOMIZED
Masking
NONE
Purpose
OTHER
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

June 3, 2022

First Posted

June 21, 2022

Study Start

August 17, 2021

Primary Completion

August 16, 2023

Study Completion

August 16, 2023

Last Updated

October 25, 2023

Record last verified: 2022-06

Data Sharing

IPD Sharing
Will not share

Locations

RE(1)