Investigating HDL Function in Type 1 Diabetic Patients with Kidney Issues

Study of High Density Lipoprotein Function in Type 1 Diabetic Patients With Nephropathy

This study is trying to see how kidney problems affect good cholesterol in people with type 1 diabetes.

Quick facts

• Study type: Observational
• Enrollment: 200 (estimated)
• Ages: 18 Years and up
• Sex: All
• Sponsor: Centre Hospitalier Universitaire Dijon (other)
• Locations: 1 site (Dijon)
• Trial ID: NCT03512132 on ClinicalTrials.gov

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.

Who should consider this trial

Good fit: Ideal candidates include adults over 18 with type 1 diabetes, particularly those with nephropathy or normal albuminuria.

Not a fit: Patients with type 2 diabetes or those under 18 years old may not benefit from this study.

Why it matters

Potential benefit: If successful, this study could lead to improved management strategies for type 1 diabetes patients with nephropathy.

How similar studies have performed: While there is ongoing research into HDL functionality in diabetes, this specific focus on nephropathy in type 1 diabetes is relatively novel.

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

Where this trial is running

Dijon

• Chu Dijon Bourogne — Dijon, France (RECRUITING)

Conditions: Type 1 Diabetes