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 @ 1:13 PM
Ignite Modification Date:
2025-12-24 @ 1:13 PM
NCT ID:
NCT01588795
Eligibility Criteria:
Inclusion Criteria:
* Type 2 diabetes mellitus male or female patient
* Individual is \> 18 and ≤ 75 years old
* Diabetic nephropathy (if no pathological examination, diagnosis based on the association of history of diabetes, diabetic retinopathy and no hematuria)
* Proteinuria/creatininuria ratio \> 0.1 g/mmol lasting for 8 weeks
* Under stable medication regimen including for at least 2 months full tolerated doses of al least 1 RAAS blocker (ACEI, renin inhibitor, ARB) and a diuretic
* 2 functional kidneys sizing ≥ 90 mm; eGFR \> 20 mL/min/1.73m² (MDRD formula
* Suitable aorto-renal vascular anatomy compatible with the endovascular denervation procedure; Informed consent has been signed
* Health insurance policy active
Exclusion Criteria:
* Patients with an estimated glomerular filtration rate (eGFR) of less than 20 mL/min/1.73 m2
* Patients unable to sign an informed consent, to understand the protocol, living too far from the specialized center
* Non-diabetic renal disease
* Patients with severe hypertension (grade 3 ESH classification)
* Kaliemia ≥ 6mmol/L
* History of nephrogenic fibrosis-induced MRI contrast media
* Patient with single functioning kidney
* Patient with contrast media allergy
* Patient with any implantable device incompatible with low frequency waves delivery
* Patient with contra-indication to the anti-proteinuric standardized medication regimen
* Patient with transient or fixed cerebral ischemia within 3 months before inclusion
* Patient with myocardial infarction, unstable angina pectoris, coronary bypass or percutaneous angioplasty within 3 months before inclusion
* Patient with asthma or chronic obstructive pulmonary disease with a contra-indication to beta-blockers medication
* Patient with type 1 diabetes mellitus
* Uncontrolled type 2 diabetes mellitus (Hb1Ac \> 10%)
* Patient with malignancy within the 5 past years
* Patient with any medical or surgical condition that could worsen the risk of the study, according to the investigator; Patient with chronic alcohol consumption
* Patient with atrial fibrillation and/or a brachial circumference of ≥ 42cm
* Patient is pregnant, nursing or planning to be pregnant
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
18 Years
Maximum Age:
75 Years
Study:
NCT01588795
Study Brief:
Protocol Section:
NCT01588795