Search for a Link Between the Different Variables for Glycaemia and Oxidative Stress or Impaired HDL Function
Holter Gly
Influence of Glycaemic Variability on Oxidative Stress and High-density Lipoprotein (HDL) Function in Type-1 Diabetes
1 other identifier
interventional
60
1 country
1
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)
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P25-P50 for not_applicable
Started May 2012
Longer than P75 for not_applicable
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
May 29, 2012
CompletedFirst Submitted
Initial submission to the registry
July 28, 2016
CompletedFirst Posted
Study publicly available on registry
August 11, 2016
CompletedPrimary Completion
Last participant's last visit for primary outcome
April 17, 2018
CompletedStudy Completion
Last participant's last visit for all outcomes
April 17, 2018
CompletedFebruary 21, 2024
February 1, 2024
5.9 years
July 28, 2016
February 19, 2024
Conditions
Outcome Measures
Primary Outcomes (4)
Average blood glucose
through study completion, an average of 7 days
Time hypoglycemia
through study completion, an average of 7 days
Time hyperglycemia
through study completion, an average of 7 days
Amplitude of glycemic variations
through study completion, an average of 7 days
Study Arms (2)
patients with type-1 diabetes
EXPERIMENTALControls
PLACEBO COMPARATORInterventions
Eligibility Criteria
You may qualify if:
- 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
You may not qualify if:
- 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
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
CHU Dijon Bourgogne
Dijon, 21079, France
MeSH Terms
Interventions
Intervention Hierarchy (Ancestors)
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- NON RANDOMIZED
- Masking
- NONE
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
July 28, 2016
First Posted
August 11, 2016
Study Start
May 29, 2012
Primary Completion
April 17, 2018
Study Completion
April 17, 2018
Last Updated
February 21, 2024
Record last verified: 2024-02