Clinical trial

Influence of Glycaemic Variability on Oxidative Stress and High-density Lipoprotein (HDL) Function in Type-1 Diabetes

Name
Duvillard Hors AOI 2011
Description
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)
Trial arms
Trial start
2012-05-29
Estimated PCD
2018-04-17
Trial end
2018-04-17
Status
Completed
Treatment
blood sample
Arms:
Controls, patients with type-1 diabetes
urine sample
Arms:
Controls, patients with type-1 diabetes
installation of Holter
Arms:
patients with type-1 diabetes
Size
60
Primary endpoint
Average blood glucose
through study completion, an average of 7 days
Time hypoglycemia
through study completion, an average of 7 days
Time hyperglycemia
through study completion, an average of 7 days
Amplitude of glycemic variations
through study completion, an average of 7 days
Eligibility criteria
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
Protocol
{'studyType': 'INTERVENTIONAL', 'phases': ['NA'], 'designInfo': {'allocation': 'NON_RANDOMIZED', 'interventionModel': 'PARALLEL', 'maskingInfo': {'masking': 'NONE'}}, 'enrollmentInfo': {'count': 60, 'type': 'ACTUAL'}}
Updated at
2024-02-21

1 organization

1 product

1 indication

Indication
Type 1 Diabetes