Description of an Immune Activation Profile Linked to Insulin Resistance in Subjects Aged 55-69
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 158
- 试验地点
- 2
- 主要终点
- fasting insulinemia
研究概览
简要总结
The aim of the study is to describe an immune activation profile of people at risk of insulin resistance based on a wide range of markers which will allow easy identification of patients at risk.
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 时间视角
- Prospective
入排标准
- 年龄范围
- 55 Years 至 69 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •The patient has been informed of the study, its objectives, constraints and the patient rights
- •The patient must have given their free and informed consent and signed the consent form
- •The patient is aged 55-69
排除标准
- •The subject is participating in an interventional category 1 study
- •The patient has participated in another category 1 interventional study in the last 3 months
- •The patient is in a period of exclusion determined by a previous study
- •The patient is under safeguard of justice or state guardianship
- •The subject refuses to sign the consent
- •The subject does not understand the information
结局指标
主要结局
fasting insulinemia
时间窗: Day 0
mIU/L
waist circumference
时间窗: Day 0
cm
B cell subpopulations
时间窗: Day 0
flow cytometry
Natural killer (NK) cell subpopulations
时间窗: Day 0
immunosenescence; number/mm3
Cluster of Differentiation 8 (CD8+) T cell subpopulations
时间窗: Day 0
immunosenescence; number/mm3
High Density Lipoprotein
时间窗: Day 0
mM/L
γ-glutamyl transpeptidase level
时间窗: Day 0
glutamic pyruvic transaminase
时间窗: Day 0
sCD14 level
时间窗: Day 0
ng/ml, enzyme-linked immunosorbent assays (ELISA)
Cluster of Differentiation 4 (CD4+) T cell subpopulations
时间窗: Day 0
immunosenescence; number/mm3
16 ribosomal ribonucleic acid (rRNA) levels
时间窗: Day 0
polymerase chain reaction (PCR); copies/µl
Intestinal Fatty Acid Binding Protein level
时间窗: Day 0
ELISA; pg/mL
Total cholesterol
时间窗: Day 0
mM/L
Low Density Lipoprotein
时间窗: Day 0
mM/L
lipopolysaccharide (LPS)-binding protein level
时间窗: Day 0
ELISA; µg/mL
hip circumference
时间窗: Day 0
cm
maximal arterial tension
时间窗: Day 0
mmHg
fasting glycemia
时间窗: Day 0
minimal arterial tension
时间窗: Day 0
mmHg
Cluster of Differentiation 163 (CD163) level
时间窗: Day 0
ng/ml, enzyme-linked immunosorbent assays (ELISA)
soluble tumor necrosis factor-alpha receptor I (sTNFRI) level
时间窗: Day 0
ng/ml, enzyme-linked immunosorbent assays (ELISA)
soluble endothelial protein C Receptro (sEPCR) level
时间窗: Day 0
ng/ml, enzyme-linked immunosorbent assays (ELISA)
tissue plasminogen activator (tPa) level
时间窗: Day 0
ng/ml, enzyme-linked immunosorbent assays (ELISA)
次要结局
- Link between immune activation profile and other features of metabolic syndrome(Day 0)
- Prevalence of insulin and metabolic syndrome(Day 0)
- Immune activation linked to the profile(Day 0)