Study of High Density Lipoprotein Function in Type 1 Diabetic Patients With Nephropathy
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 200
- 试验地点
- 1
- 主要终点
- Ability to induce cholesterol efflux
研究概览
简要总结
A number of arguments suggest that the deterioration in high density lipoproteins (HDL) functioning may worsen with the development of nephropathy during type 1 diabetes (T1D).
The objective of this study will be to investigate to what extent nephropathy in T1D patients in the microalbuminuria and macroalbuminuria stages, compared to T1D patients without nephropathy, is associated with an alteration in HDL functionality and changes in HDL size and composition (lipids with detailed study of phosphates and sphingolipids, main lipoproteins, inflammatory markers).
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
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •INCLUSION CRITERIA GROUP C (CONTROLS) :
- •age > 18 years
- •a person who has given oral consent
- •Non-diabetics
- •Fasting plasma glucose < 6.10 mmol/L (1.1 g/L)
- •Triglyceridemia < 1.7 mmol/L (1.5 g/l)
- •HDL-C concentration > 1.30 mmol/L (for women and 1.03 mmol/L for men)
- •Glomerular filtration flow rate > 90 mL/min/1.73m2 (These thresholds correspond to the standard thresholds for these parameters)
- •INCLUSION CRITERIA GROUP T1D-N (WITH NORMAL ALBUMINURIA) :
- •age > 18 years
- •a person who has given oral consent
- •Diabetic type 1 (based on the patient's clinical history and/or the presence of anti-glutamate decarboxylase autoantibodies and/or plasma C-peptide less than 0.5 ng/l)
- •HbA1c between 6 and 9%.
- •normal albuminuria (albumin/creatinine ratio < 2.5 mg/mmol in men and < 3.5 in women)
- •glomerular filtration rate > 90 mL/min/1.73m2
- •INCLUSION CRITERIA GROUP T1D-MICRO (WITH MICROALBUMINURIA)
- •age > 18 years
- •a person who has given oral consent
- •Diabetic type 1 (based on the patient's clinical history and/or the presence of anti-glutamate decarboxylase autoantibodies and/or plasma C-peptide less than 0.5 ng/l)
- •HbA1c between 6 and 9%.
- •Microalbuminuria (albumin/creatinine ratio > 2.5 mg/mmol in men and > 3.5 in women, and < 30 mg/mmol)
- •glomerular filtration rate > 90 mL/min/1.73m2
- •INCLUSION CRITERIA GROUP T1D-MACRO (WITH MACROALBUMINURIA)
- •age > 18 years
- •a person who has given oral consent
- •Diabetic type 1 (based on the patient's clinical history and/or the presence of anti-glutamate decarboxylase autoantibodies and/or plasma C-peptide less than 0.5 ng/l)
- •HbA1c between 6 and 9%.
- •Macroalbuminuria (albumin/creatinine ratio > 30 mg/mmol)
- •glomerular filtration rate > 45 mL/min/1.73m2
排除标准
- •Protected adult
- •Patient not affiliated to a social security scheme
- •Pregnant or breastfeeding woman
- •Drugs interfering with lipid metabolism outside insulin for DT1 : hypolipidemic (only for patients included in the DT1-micro group), corticosteroid, estroprogestogens, retinoic acid, antiproteases.
- •BMI > 30 kg/m2
结局指标
主要结局
Ability to induce cholesterol efflux
时间窗: inclusion
amount of cholesterol captured from cells expressed as %.
Nitric oxide synthesis
时间窗: inclusion
variation in the presence of HDL compared to the basal state, i.e. in the absence of HDL
Anti-inflammatory effect
时间窗: inclusion
variation in the expression of adhesion molecules (VCAM-1 \[vascular cell adhesion molecule 1\], ICAM-1 \[InterCellular Adhesion Molecule 1\] and E selectin) under the influence of TNF-alpha \[Tumor Necrosis Factor alpha\] in the presence of HDL compared to the absence of HDL.
次要结局
未报告次要终点