NCT03512132 Study of High Density Lipoprotein Function in Type 1 Diabetic Patients With Nephropathy
| NCT ID | NCT03512132 |
| Status | Recruiting |
| Phase | — |
| Sponsor | Centre Hospitalier Universitaire Dijon |
| Condition | Type 1 Diabetes |
| Study Type | OBSERVATIONAL |
| Enrollment | 200 participants |
| Start Date | 2018-04-24 |
| Primary Completion | 2026-04 |
Eligibility & Interventions
Eligibility Fast-Check
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What to Expect as a Participant
This is an observational study. You will not receive an experimental treatment; researchers will collect data based on your existing condition or standard treatment.
This trial targets 200 participants in total. It began in 2018-04-24 with a primary completion date of 2026-04.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
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).
Eligibility Criteria
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
Frequently Asked Questions
Who can join the NCT03512132 clinical trial?
This trial is open to participants of all sexes, aged 18 Years or older, studying Type 1 Diabetes. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
Is NCT03512132 currently recruiting?
Yes, NCT03512132 is actively recruiting participants. Visit ClinicalTrials.gov or contact Centre Hospitalier Universitaire Dijon to inquire about joining.
Where is the NCT03512132 trial being conducted?
This trial is being conducted at Dijon, France.
Who is sponsoring the NCT03512132 clinical trial?
NCT03512132 is sponsored by Centre Hospitalier Universitaire Dijon. The trial plans to enroll 200 participants.
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