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RECRUITING

NCT03512132

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

Sponsor: Centre Hospitalier Universitaire Dijon

View on ClinicalTrials.gov

Summary

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).

Key Details

Gender

All

Age Range

18 Years - Any

Study Type

OBSERVATIONAL

Enrollment

200

Start Date

2018-04-24

Completion Date

2026-04

Last Updated

2024-07-19

Healthy Volunteers

Yes

Conditions

Type 1 Diabetes

Interventions

BIOLOGICAL

Blood samples

5 EDTA tubes of 7ml and 1 dry tube of 7 ml taken on an empty stomach

BIOLOGICAL

Urine sample

Urine sample on an empty stomach

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

Locations (1)

Chu Dijon Bourogne

Dijon, France