Study of High Density Lipoprotein Function in Type 1 Diabetic Patients With Nephropathy

Study Overview
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Brief Summary
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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).

Official Title
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Study of High Density Lipoprotein Function in Type 1 Diabetic Patients With Nephropathy

Conditions
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Type 1 Diabetes

Intervention / Treatment
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* Biological: Blood samples
* Biological: Urine sample


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: 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 Exclusion Criteria: 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

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| control<br> | Biological: Blood samples<br>* 5 EDTA tubes of 7ml and 1 dry tube of 7 ml taken on an empty stomach<br>Biological: Urine sample<br>* Urine sample on an empty stomach<br>|
| T1D with normal albumin levels<br> | Biological: Blood samples<br>* 5 EDTA tubes of 7ml and 1 dry tube of 7 ml taken on an empty stomach<br>Biological: Urine sample<br>* Urine sample on an empty stomach<br>|
| T1D with macroalbuminuria<br> | Biological: Blood samples<br>* 5 EDTA tubes of 7ml and 1 dry tube of 7 ml taken on an empty stomach<br>Biological: Urine sample<br>* Urine sample on an empty stomach<br>|
| T1D with microalbuminuria<br> | Biological: Blood samples<br>* 5 EDTA tubes of 7ml and 1 dry tube of 7 ml taken on an empty stomach<br>Biological: Urine sample<br>* Urine sample on an empty stomach<br>|
| T1D with microalbuminuria and statins<br> | Biological: Blood samples<br>* 5 EDTA tubes of 7ml and 1 dry tube of 7 ml taken on an empty stomach<br>Biological: Urine sample<br>* Urine sample on an empty stomach<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Ability to induce cholesterol efflux | amount of cholesterol captured from cells expressed as %. | inclusion | 
| Nitric oxide synthesis | variation in the presence of HDL compared to the basal state, i.e. in the absence of HDL | inclusion | 
| Anti-inflammatory effect | 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. | inclusion |