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OpenTrials
Completed

NCT Number: NCT02862860

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

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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Key information

Conditions

Type-1 Diabetes

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

CHU Dijon Bourgogne

Dijon, 21079, France

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Blood sample

Biological

urine sample

Biological

installation of Holter

Device

Primary outcomes

  1. Average blood glucose

    Time frame: through study completion, an average of 7 days

  2. Time hypoglycemia

    Time frame: through study completion, an average of 7 days

  3. Time hyperglycemia

    Time frame: through study completion, an average of 7 days

  4. Amplitude of glycemic variations

    Time frame: through study completion, an average of 7 days

Sponsors and collaborators

Lead sponsor

Centre Hospitalier Universitaire Dijon

Other

Registry information

Official study title

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

Acronym: Holter Gly

Important dates

Study start
2012
Primary completion
2018
Study completion
2018
First posted
Aug 11, 2016
Registry last updated
Feb 21, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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