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:
2025-12-24 @ 9:34 PM
Ignite Modification Date:
2025-12-24 @ 9:34 PM
NCT ID:
NCT03512132
Eligibility Criteria:
Inclusion Criteria:
INCLUSION CRITERIA GROUP C (CONTROLS) :
* age \> 18 years
* a person who has given oral consent
* Non-diabetics
* Fasting plasma glucose \< 6.10 mmol/L (1.1 g/L)
* Triglyceridemia \< 1.7 mmol/L (1.5 g/l)
* HDL-C concentration \> 1.30 mmol/L (for women and 1.03 mmol/L for men)
* Glomerular filtration flow rate \> 90 mL/min/1.73m2 (These thresholds correspond to the standard thresholds for these parameters)
INCLUSION CRITERIA GROUP T1D-N (WITH NORMAL ALBUMINURIA) :
* age \> 18 years
* a person who has given oral consent
* Diabetic type 1 (based on the patient's clinical history and/or the presence of anti-glutamate decarboxylase autoantibodies and/or plasma C-peptide less than 0.5 ng/l)
* HbA1c between 6 and 9%.
* normal albuminuria (albumin/creatinine ratio \< 2.5 mg/mmol in men and \< 3.5 in women)
* glomerular filtration rate \> 90 mL/min/1.73m2
INCLUSION CRITERIA GROUP T1D-MICRO (WITH MICROALBUMINURIA)
* age \> 18 years
* a person who has given oral consent
* Diabetic type 1 (based on the patient's clinical history and/or the presence of anti-glutamate decarboxylase autoantibodies and/or plasma C-peptide less than 0.5 ng/l)
* HbA1c between 6 and 9%.
* Microalbuminuria (albumin/creatinine ratio \> 2.5 mg/mmol in men and \> 3.5 in women, and \< 30 mg/mmol)
* glomerular filtration rate \> 90 mL/min/1.73m2
INCLUSION CRITERIA GROUP T1D-MACRO (WITH MACROALBUMINURIA)
* age \> 18 years
* a person who has given oral consent
* Diabetic type 1 (based on the patient's clinical history and/or the presence of anti-glutamate decarboxylase autoantibodies and/or plasma C-peptide less than 0.5 ng/l)
* HbA1c between 6 and 9%.
* Macroalbuminuria (albumin/creatinine ratio \> 30 mg/mmol)
* glomerular filtration rate \> 45 mL/min/1.73m2
Exclusion Criteria:
* Protected adult
* Patient not affiliated to a social security scheme
* Pregnant or breastfeeding woman
* Drugs interfering with lipid metabolism outside insulin for DT1 : hypolipidemic (only for patients included in the DT1-micro group), corticosteroid, estroprogestogens, retinoic acid, antiproteases.
* BMI \> 30 kg/m2
Healthy Volunteers:
True
Sex:
ALL
Minimum Age:
18 Years
Study:
NCT03512132
Study Brief:
Protocol Section:
NCT03512132