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

Type-1 Diabetes Clinical Trial

— Holter Gly  

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02862860
• Other study ID #: Duvillard Hors AOI 2011
• Status: Completed
• Phase: N/A
• Start date: May 29, 2012
• Est. completion date: April 17, 2018

Study information

• Verified date: February 2024
• Source: Centre Hospitalier Universitaire Dijon
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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)

Recruitment information / eligibility

• Status: Completed
• Enrollment: 60
• Est. completion date: April 17, 2018
• Est. primary completion date: April 17, 2018
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Diabetes Mellitus, Type 1
• Type-1 Diabetes

Intervention

Biological:
• blood sample

• urine sample

Device:
• installation of Holter

Locations

Country	Name	City	State
France	CHU Dijon Bourgogne	Dijon

Sponsors (1)

Lead Sponsor	Collaborator
Centre Hospitalier Universitaire Dijon

Country where clinical trial is conducted

France, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Average blood glucose		through study completion, an average of 7 days
Primary	Time hypoglycemia		through study completion, an average of 7 days
Primary	Time hyperglycemia		through study completion, an average of 7 days
Primary	Amplitude of glycemic variations		through study completion, an average of 7 days