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NCT Number: NCT03512132

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

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).

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Key information

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

blood samples

Biological

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

urine sample

Biological

Urine sample on an empty stomach

Primary outcomes

  1. Ability to induce cholesterol efflux

    Time frame: inclusion

    amount of cholesterol captured from cells expressed as %.

  2. Nitric oxide synthesis

    Time frame: inclusion

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

  3. 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.

Sponsors and collaborators

Lead sponsor

Centre Hospitalier Universitaire Dijon

Other

Registry information

Acronym: DID&NEPHRO

Important dates

Study start
2018
Primary completion
2026
Study completion
2026
First posted
Apr 30, 2018
Registry last updated
Jul 19, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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