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

Recruiting

• Conditions: Type 1 Diabetes
• Interventions: Biological: Blood samples; Biological: Urine sample

• Registration Number: NCT03512132
• Lead Sponsor: Centre Hospitalier Universitaire Dijon

Brief 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).

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2018-04-11
• Study First Submitted QC: 2018-04-18
• Study Start: 2018-04-24
• Study First Posted: 2018-04-30
• Status Verified: 2024-07
• Last Update Submitted: 2024-07-18
• Last Update Posted: 2024-07-19
• Primary Completion: 2026-04
• Study Completion: 2026-04

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 200

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

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
T1D with microalbuminuria and statins	Urine sample	-
T1D with microalbuminuria	Blood samples	-
T1D with microalbuminuria	Urine sample	-
T1D with microalbuminuria and statins	Blood samples	-
control	Urine sample	-
T1D with normal albumin levels	Blood samples	-
control	Blood samples	-
T1D with normal albumin levels	Urine sample	-
T1D with macroalbuminuria	Urine sample	-
T1D with macroalbuminuria	Blood samples	-

Primary Outcome Measures

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

Trial Locations

Locations (1)

Chu Dijon Bourogne; 🇫🇷 Dijon, France