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

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

60 participants

Study Classification

INTERVENTIONAL

Study Start Date

2012-05-29

Study Completion Date

2018-04-17

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)

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Detailed Description

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Conditions

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Type-1 Diabetes

Study Design

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Allocation Method

NON_RANDOMIZED

Intervention Model

PARALLEL

Blinding Strategy

NONE

Study Groups

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patients with type-1 diabetes

Group Type EXPERIMENTAL

blood sample

Intervention Type BIOLOGICAL

urine sample

Intervention Type BIOLOGICAL

installation of Holter

Intervention Type DEVICE

Controls

Group Type PLACEBO_COMPARATOR

blood sample

Intervention Type BIOLOGICAL

urine sample

Intervention Type BIOLOGICAL

Interventions

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blood sample

Intervention Type BIOLOGICAL

urine sample

Intervention Type BIOLOGICAL

installation of Holter

Intervention Type DEVICE

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

Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes