Study of High Density Lipoprotein Function in Type 1 Diabetic Patients With Nephropathy (DID&NEPHRO)

University Hospital Center (CHU) Dijon Bourgogne

Status

Enrolling

Conditions

Type 1 Diabetes

Treatments

Biological: Blood samples

Biological: Urine sample

Study type

Observational

Funder types

Other

Identifiers

NCT03512132

DUVILLARD 2017

Details and patient eligibility

About

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).

Enrollment

200 estimated patients

Sex

All

Ages

18+ years old

Volunteers

Accepts Healthy Volunteers

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