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

February 19, 2024 updated by: Centre Hospitalier Universitaire Dijon

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

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)

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

60

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Locations

  • France
      • Dijon, France, 21079
        • CHU Dijon Bourgogne

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

Yes

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

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

Arms and Interventions

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

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Average blood glucose
Time Frame: through study completion, an average of 7 days
through study completion, an average of 7 days
Time hypoglycemia
Time Frame: through study completion, an average of 7 days
through study completion, an average of 7 days
Time hyperglycemia
Time Frame: through study completion, an average of 7 days
through study completion, an average of 7 days
Amplitude of glycemic variations
Time Frame: through study completion, an average of 7 days
through study completion, an average of 7 days

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Centre Hospitalier Universitaire Dijon

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

May 29, 2012

Primary Completion (Actual)

April 17, 2018

Study Completion (Actual)

April 17, 2018

Study Registration Dates

First Submitted

July 28, 2016

First Submitted That Met QC Criteria

August 10, 2016

First Posted (Estimated)

August 11, 2016

Study Record Updates

Last Update Posted (Estimated)

February 21, 2024

Last Update Submitted That Met QC Criteria

February 19, 2024

Last Verified

February 1, 2024

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • Duvillard Hors AOI 2011

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

Clinical Trials on Type-1 Diabetes

Clinical Trials on blood sample

Search Similar Trials

Sponsors and Collaborators

Medical Conditions

Drug Interventions

CROs by country

CROs in Lebanon

Conditions

Rare Diseases

Drug Interventions

Dietary Supplements

Sponsor/Collaborators

Locations

3
Subscribe