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

Not Applicable

Completed

• Conditions: Type-1 Diabetes
• Interventions: Biological: blood sample; Biological: urine sample; Device: installation of Holter

• Registration Number: NCT02862860
• Lead Sponsor: Centre Hospitalier Universitaire Dijon

Brief Summary

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)

Detailed Description

Not available

Study Timeline

• Study Start: 2012-05-29
• Study First Submitted: 2016-07-28
• Study First Submitted QC: 2016-08-10
• Study First Posted: 2016-08-11
• Primary Completion: 2018-04-17
• Study Completion: 2018-04-17
• Status Verified: 2024-02
• Last Update Submitted: 2024-02-19
• Last Update Posted: 2024-02-21

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 60

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Controls	urine sample	-
patients with type-1 diabetes	urine sample	-
Controls	blood sample	-
patients with type-1 diabetes	blood sample	-
patients with type-1 diabetes	installation of Holter	-

Primary Outcome Measures

Name	Time	Method
Time hyperglycemia	through study completion, an average of 7 days
Amplitude of glycemic variations	through study completion, an average of 7 days
Average blood glucose	through study completion, an average of 7 days
Time hypoglycemia	through study completion, an average of 7 days

Trial Locations

Locations (1)

CHU Dijon Bourgogne; 🇫🇷 Dijon, France