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

Study Overview
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Brief Summary
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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)

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

Conditions
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Type-1 Diabetes

Intervention / Treatment
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* Biological: blood sample
* Biological: urine sample
* Device: installation of Holter


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Allocation: Non-Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: patients with type-1 diabetes<br> | Biological: blood sample<br> <br> Biological: urine sample<br> <br> Device: installation of Holter<br> <br> |
| Placebo Comparator: Controls<br> | Biological: blood sample<br> <br> Biological: urine sample<br> <br> |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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 |