Skip to content

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

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

Status
Recruiting
Phases
Unknown
Study type
Observational
Source
ClinicalTrials.gov
Registry ID
NCT03512132
Acronym
DID&NEPHRO
Enrollment
200
Registered
2018-04-30
Start date
2018-04-24
Completion date
2026-04-30
Last updated
2024-07-19

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Type 1 Diabetes

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).

Interventions

BIOLOGICALBlood samples

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

BIOLOGICALUrine sample

Urine sample on an empty stomach

Sponsors

Centre Hospitalier Universitaire Dijon
Lead SponsorOTHER

Study design

Observational model
COHORT
Time perspective
PROSPECTIVE

Eligibility

Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
Yes

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

Design outcomes

Primary

MeasureTime frameDescription
Ability to induce cholesterol effluxinclusionamount of cholesterol captured from cells expressed as %.
Nitric oxide synthesisinclusionvariation in the presence of HDL compared to the basal state, i.e. in the absence of HDL
Anti-inflammatory effectinclusionvariation 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.

Countries

France

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026