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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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

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

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).

Study Type

Interventional

Primary Outcome

Insulin Regulated Amino Peptidase sérique (IRAPs) levels

Secondary Outcome

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

Condition

Lipodystrophy

Intervention

research-specific blood sample

Study Arms / Comparison Groups

 Subjects with Dunnigan's Lipodystrophy
Description:

Publications

* Includes publications given by the data provider as well as publications identified by National Clinical Trials Identifier (NCT ID) in Medline.

Recruitment Information

Recruitment Status

Other

Estimated Enrollment

210

Start Date

August 17, 2021

Completion Date

December 2024

Primary Completion Date

August 2024

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

Gender

All

Ages

18 Years - N/A

Accepts Healthy Volunteers

No

Contacts

, 02 62 35 97 50, [email protected]

Location Countries

Réunion

Location Countries

Réunion

Administrative Informations

NCT ID

NCT05424913

Organization ID

2017/CHU/07-2021-A00105-36

Responsible Party

Sponsor

Study Sponsor

Centre Hospitalier Universitaire de la Réunion

Study Sponsor

, ,

Verification Date

June 2022