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临床试验/NCT05424913
NCT05424913已完成不适用

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

Centre Hospitalier Universitaire de la Réunion2 个研究点 分布在 1 个国家目标入组 150 人开始时间: 2021年8月17日最近更新:
适应症

试验速览

阶段
不适用
状态
已完成
发起方
入组人数
150
试验地点
2
主要终点
Insulin Regulated Amino Peptidase sérique (IRAPs) levels

研究概览

简要总结

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).

研究设计

研究类型
Interventional
分配方式
Non Randomized
干预模型
Parallel
主要目的
Other
盲法
None

入排标准

年龄范围
18 Years 至 —(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • Subjects with Dunnigan's Lipodystrophy OR Non-lipodystrophic insulin-resistant subjects OR Insulin-sensitive non-lipodystrophic subjects
  • 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.

排除标准

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

结局指标

主要结局

Insulin Regulated Amino Peptidase sérique (IRAPs) levels

时间窗: at inclusion

Insulin Regulated Amino Peptidase sérique (IRAPs)

inflammation markers levels

时间窗: at inclusion

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

时间窗: at inclusion

662 plasma lipid species

次要结局

  • Compare levels of lipidome markers between the 3 categories of participants(at inclusion)
  • Compare levels of inflammation markers between the 3 categories of participants(at inclusion)
  • Compare levels of Insulin Regulated Amino Peptidase sérique (IRAPs) between the 3 categories of participants(at inclusion)

研究者

发起方
Centre Hospitalier Universitaire de la Réunion
申办方类型
Other
责任方
Sponsor

研究点 (2)

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