Eligibility Module
The Eligibility Module contains detailed information about who can participate in the clinical trial. This includes eligibility criteria, age restrictions, gender requirements, healthy volunteer status, and study population descriptions, helping researchers understand who is eligible to participate in the study.
Eligibility Module path is as follows:
Study -> Protocol Section -> Eligibility Module
Eligibility Module
Ignite Creation Date:
2025-12-25 @ 2:15 AM
Ignite Modification Date:
2025-12-25 @ 2:15 AM
NCT ID:
NCT02862860
Eligibility Criteria:
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
Healthy Volunteers:
True
Sex:
ALL
Minimum Age:
18 Years
Study:
NCT02862860
Study Brief:
Protocol Section:
NCT02862860