DID&NEPHRO: Study of High Density Lipoprotein Function in Type 1 Diabetic Patients With Nephropathy

Sponsor

Centre Hospitalier Universitaire Dijon (Other)

Overall Status

Recruiting

CT.gov ID

NCT03512132

Collaborator

(none)

200

Enrollment

Location

79.3

Anticipated Duration (Months)

2.5

Patients Per Site Per Month

Study Details

Study Description

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).

Condition or Disease	Intervention/Treatment	Phase
Type 1 Diabetes	Biological: Blood samples Biological: Urine sample

Study Design

Study Type:

Observational

Anticipated Enrollment :

200 participants

Observational Model:

Cohort

Time Perspective:

Prospective

Official Title:

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

Actual Study Start Date :

Apr 24, 2018

Anticipated Primary Completion Date :

Apr 1, 2024

Anticipated Study Completion Date :

Dec 1, 2024

Arms and Interventions

Arm	Intervention/Treatment
control	Biological: Blood samples 5 EDTA tubes of 7ml and 1 dry tube of 7 ml taken on an empty stomach Biological: Urine sample Urine sample on an empty stomach
T1D with normal albumin levels	Biological: Blood samples 5 EDTA tubes of 7ml and 1 dry tube of 7 ml taken on an empty stomach Biological: Urine sample Urine sample on an empty stomach
T1D with macroalbuminuria	Biological: Blood samples 5 EDTA tubes of 7ml and 1 dry tube of 7 ml taken on an empty stomach Biological: Urine sample Urine sample on an empty stomach
T1D with microalbuminuria	Biological: Blood samples 5 EDTA tubes of 7ml and 1 dry tube of 7 ml taken on an empty stomach Biological: Urine sample Urine sample on an empty stomach
T1D with microalbuminuria and statins	Biological: Blood samples 5 EDTA tubes of 7ml and 1 dry tube of 7 ml taken on an empty stomach Biological: Urine sample Urine sample on an empty stomach

Outcome Measures

Primary Outcome Measures

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.

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years and Older

Sexes Eligible for Study:

All

Accepts 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

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Chu Dijon Bourogne	Dijon		France	21000

Sponsors and Collaborators

Centre Hospitalier Universitaire Dijon

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

Responsible Party:

Centre Hospitalier Universitaire Dijon

ClinicalTrials.gov Identifier:

NCT03512132

Other Study ID Numbers:

DUVILLARD 2017

First Posted:

Apr 30, 2018

Last Update Posted:

Jun 9, 2022

Last Verified:

Jun 1, 2022

Studies a U.S. FDA-regulated Drug Product:

Studies a U.S. FDA-regulated Device Product:

Additional relevant MeSH terms:

Kidney Diseases

Diabetes Mellitus, Type 1

Study Results

No Results Posted as of Jun 9, 2022