Search for a Link Between the Different Variables for Glycaemia and Oxidative Stress or Impaired … (NCT02862860) | Clinical Trial Compass
CompletedNot Applicable
Search for a Link Between the Different Variables for Glycaemia and Oxidative Stress or Impaired HDL Function
France60 participantsStarted 2012-05-29
Plain-language 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)
Who can participate
Age range
18 Years
Sex
ALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
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
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.
What they're measuring
1
Average blood glucose
Timeframe: through study completion, an average of 7 days
2
Time hypoglycemia
Timeframe: through study completion, an average of 7 days
3
Time hyperglycemia
Timeframe: through study completion, an average of 7 days
4
Amplitude of glycemic variations
Timeframe: through study completion, an average of 7 days