Study of High Density Lipoprotein Function in Type 1 Diabetic Patients With Nephropathy
Centre Hospitalier Universitaire Dijon
200 participants
Apr 24, 2018
OBSERVATIONAL
Conditions
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).
Eligibility
Inclusion Criteria25
- 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
- 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
- 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 Criteria5
- 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
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Interventions
5 EDTA tubes of 7ml and 1 dry tube of 7 ml taken on an empty stomach
Urine sample on an empty stomach
Locations(1)
View Full Details on ClinicalTrials.gov
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NCT03512132