NCT03512132

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).

Trial Health

57
Monitor

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
200

participants targeted

Target at P75+ for all trials

Timeline
Completed

Started Apr 2018

Longer than P75 for all trials

Geographic Reach
1 country

1 active site

Status
recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

April 11, 2018

Completed
13 days until next milestone

Study Start

First participant enrolled

April 24, 2018

Completed
6 days until next milestone

First Posted

Study publicly available on registry

April 30, 2018

Completed
7.9 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

April 1, 2026

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

April 1, 2026

Completed
Last Updated

July 19, 2024

Status Verified

July 1, 2024

Enrollment Period

7.9 years

First QC Date

April 11, 2018

Last Update Submit

July 18, 2024

Conditions

Type 1 Diabetes

Outcome Measures

Primary Outcomes (3)

  • Ability to induce cholesterol efflux

    amount of cholesterol captured from cells expressed as %.

    inclusion

  • Nitric oxide synthesis

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

    inclusion

  • Anti-inflammatory effect

    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.

    inclusion

Study Arms (5)

control

Biological: Blood samplesBiological: Urine sample

T1D with normal albumin levels

Biological: Blood samplesBiological: Urine sample

T1D with macroalbuminuria

Biological: Blood samplesBiological: Urine sample

T1D with microalbuminuria

Biological: Blood samplesBiological: Urine sample

T1D with microalbuminuria and statins

Biological: Blood samplesBiological: Urine sample

Interventions

Blood samplesBIOLOGICAL

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

T1D with macroalbuminuriaT1D with microalbuminuriaT1D with microalbuminuria and statinsT1D with normal albumin levelscontrol
Urine sampleBIOLOGICAL

Urine sample on an empty stomach

T1D with macroalbuminuriaT1D with microalbuminuriaT1D with microalbuminuria and statinsT1D with normal albumin levelscontrol

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

patients treated in the Endocrinology, Diabetology or Nephrology departments of the CHU Dijon Bourgogne or in local nephrology or diabetology practices

You may qualify if:

  • 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)
  • 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
  • age \> 18 years
  • a person who has given oral consent
  • +10 more criteria

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Chu Dijon Bourogne

Dijon, 21000, France

RECRUITING

MeSH Terms

Conditions

Diabetes Mellitus, Type 1

Interventions

Blood Specimen Collection

Condition Hierarchy (Ancestors)

Diabetes MellitusGlucose Metabolism DisordersMetabolic DiseasesNutritional and Metabolic DiseasesEndocrine System DiseasesAutoimmune DiseasesImmune System Diseases

Intervention Hierarchy (Ancestors)

Specimen HandlingClinical Laboratory TechniquesDiagnostic Techniques and ProceduresDiagnosisPuncturesSurgical Procedures, OperativeInvestigative Techniques

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

April 11, 2018

First Posted

April 30, 2018

Study Start

April 24, 2018

Primary Completion

April 1, 2026

Study Completion

April 1, 2026

Last Updated

July 19, 2024

Record last verified: 2024-07

Locations

FR(1)