Investigating HDL Function in Type 1 Diabetic Patients with Kidney Issues

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

This observational study aims to explore how nephropathy affects high density lipoprotein (HDL) functionality in patients with type 1 diabetes. It will compare T1D patients with nephropathy at different stages (microalbuminuria and macroalbuminuria) to those without nephropathy, focusing on alterations in HDL size, composition, and associated inflammatory markers. Blood and urine samples will be collected to assess these parameters and their relationship with kidney function. The study seeks to deepen understanding of HDL's role in diabetic nephropathy.

Why it matters

Who can join: the full rules

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

Where it's running

• Chu Dijon Bourogne
  Dijon, France Recruiting

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.