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Clinical Trials/NCT03512132
NCT03512132
Recruiting
Not Applicable

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

Centre Hospitalier Universitaire Dijon1 site in 1 country200 target enrollmentApril 24, 2018
ConditionsType 1 Diabetes

Overview

Phase
Not Applicable
Intervention
Not specified
Conditions
Type 1 Diabetes
Sponsor
Centre Hospitalier Universitaire Dijon
Enrollment
200
Locations
1
Primary Endpoint
Ability to induce cholesterol efflux
Status
Recruiting
Last Updated
last year

Overview

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).

Registry
clinicaltrials.gov
Start Date
April 24, 2018
End Date
April 2026
Last Updated
last year
Study Type
Observational
Sex
All

Investigators

Responsible Party
Sponsor

Eligibility Criteria

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

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

Outcomes

Primary Outcomes

Ability to induce cholesterol efflux

Time Frame: inclusion

amount of cholesterol captured from cells expressed as %.

Nitric oxide synthesis

Time Frame: inclusion

variation in the presence of HDL compared to the basal state, i.e. in the absence of HDL

Anti-inflammatory effect

Time Frame: 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.

Study Sites (1)

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