Study of High Density Lipoprotein Function in Type 1 Diabetic Patients With Nephropathy
NCT ID: NCT03512132
Last Updated: 2024-07-19
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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RECRUITING
200 participants
OBSERVATIONAL
2018-04-24
2026-04-30
Brief Summary
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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).
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Detailed Description
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Conditions
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Study Design
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COHORT
PROSPECTIVE
Study Groups
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control
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
T1D with normal albumin levels
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
T1D with macroalbuminuria
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
T1D with microalbuminuria
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
T1D with microalbuminuria and statins
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
Interventions
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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
Eligibility Criteria
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Inclusion Criteria
* 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 Criteria
* 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
18 Years
ALL
Yes
Sponsors
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Centre Hospitalier Universitaire Dijon
OTHER
Responsible Party
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Locations
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Chu Dijon Bourogne
Dijon, , France
Countries
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Facility Contacts
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Other Identifiers
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DUVILLARD 2017
Identifier Type: -
Identifier Source: org_study_id
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