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

Type 1 Diabetes Clinical Trial

— DID&NEPHRO  

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT03512132
• Other study ID #: DUVILLARD 2017
• Status: Recruiting
• Start date: April 24, 2018
• Est. completion date: December 2024

Study information

• Verified date: February 2024
• Source: Centre Hospitalier Universitaire Dijon
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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).

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 200
• Est. completion date: December 2024
• Est. primary completion date: April 2024
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Diabetes Mellitus, Type 1
• Kidney Diseases
• Type 1 Diabetes

Intervention

Biological:
• Blood samples
5 EDTA tubes of 7ml and 1 dry tube of 7 ml taken on an empty stomach
• Urine sample
Urine sample on an empty stomach

Locations

Country	Name	City	State
France	Chu Dijon Bourogne	Dijon

Sponsors (1)

Lead Sponsor	Collaborator
Centre Hospitalier Universitaire Dijon

Country where clinical trial is conducted

France, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Ability to induce cholesterol efflux	amount of cholesterol captured from cells expressed as %.	inclusion
Primary	Nitric oxide synthesis	variation in the presence of HDL compared to the basal state, i.e. in the absence of HDL	inclusion
Primary	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