Search for a Link Between the Different Variables for Glycaemia and Oxidative Stress or Impaired HDL Function (Holter Gly)

University Hospital Center (CHU) Dijon Bourgogne

Status: Completed

Conditions: Type-1 Diabetes

Treatments: Device: installation of Holter; Biological: urine sample; Biological: blood sample

Study type: Interventional

Funder types: Other

Identifiers

NCT02862860

Duvillard Hors AOI 2011

Details and patient eligibility

About

As glycaemic variability on the one hand and hypoglycaemia on the other are associated with oxidative stress and inflammation, they are likely, in type-1 diabetic patients, to affect the oxidation of lipoproteins and HDL function, by altering their anti-atherogenic properties.

The aim of this study is thus to determine, in patients with Type 1 Diabetic (T1D) who will wear a glycaemic Holter for 1 week, the glycaemia parameters (mean glycaemia, duration of hypoglycaemia, duration of hyperglycaemia, mean amplitude of glycaemic excursions) associated with proatherogenic alterations in lipoproteins, in particular:

• LDL oxidation
• HDL oxidation and alterations of HDL function (anti-inflammatory capacity, antioxidant capacity)

Enrollment: 60 patients

Sex: All

Ages: 18+ years old

Volunteers: Accepts Healthy Volunteers

Inclusion criteria

• Patients who have provided written consent
• Patients with national health insurance cover

Patients with T1D

• T1D Patients treated with insulin via a pump or multiple injections
• HbA1c < 9.5 %

Control patients

• Normal fasting glycaemia (< 6.1 mmol/L)
• Age > 18 years, matched for sex and age with T1D patients

All patients

• Normal serum HDL cholesterol (> 1.04 mmol/L in men, > 1.30 mmol:L in women)
• Serum LDL cholesterol < 5 mmol/L
• triglyceridemia < 1.7 mmol/L
• Waist circumference < 102 cm in men, < 88 cm in women

Exclusion criteria

• Smoking
• Kidney failure (Creatinine clearance< 60 ml/min/1.73 m2)
• Liver failure
• Dysthyroidism
• Medication that interferes with lipoprotein metabolism (lipid-lowering agents, oestroprogestative, anti-HIV, corticoids, retinoic acid), unless stopped for at least one 1 month
• Antioxidant (vitamin E, dietary supplements, DHA)
• Pregnancy of more than 15d

Trial design

60 participants in 2 patient groups, including a placebo group

patients with type-1 diabetes

Experimental group

Treatment:

Biological: urine sample

Biological: blood sample

Device: installation of Holter

Controls

Placebo Comparator group

Treatment:

Biological: urine sample

Biological: blood sample