NCT03512132Recruiting
Study of High Density Lipoprotein Function in Type 1 Diabetic Patients With Nephropathy
Source: ClinicalTrials.gov · Last updated 30 Oct 2026
Brief summary (registry, in English)
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).
- Status (registry)
- Recruiting
- Study type
- Observational
- Enrollment
- 200 (estimated)
- First submitted
- 11 Apr 2018
- Start date
- 24 Apr 2018
- Primary completion date
- Oct 2027
- Lead sponsor
- Centre Hospitalier Universitaire Dijon
- Diseases
- Type 1 diabetes
- NCT number
- NCT03512132
What you commit to
- Study type: Observational
- Planned participants: 200
- From 24 Apr 2018 to the primary completion date, Oct 2027
- 1 site in 1 country
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.
Who cannot take part
Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.
Prior treatment
- Drugs interfering with lipid metabolism outside insulin for DT1 : hypolipidemic (only for patients included in the DT1-micro group), corticosteroid, estroprogestogens, retinoic acid, antiproteases.
Other
- Protected adult
- Patient not affiliated to a social security scheme
- Pregnant or breastfeeding woman
- BMI \> 30 kg/m2
Who the study is looking for
- 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
Age in the registry: 18 years to - · Sex: All · Accepts healthy volunteers
Sites (1)
Sites in registry order. Save your city in your profile to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| Chu Dijon Bourogne Coordinator of this site? Confirm its status | Dijon | France | Recruiting |
This page is information, not medical advice. Discuss any trial with your doctor.