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 @ 3:23 AM
Ignite Modification Date:
2025-12-25 @ 3:23 AM
NCT ID:
NCT06425705
Eligibility Criteria:
Inclusion Criteria:
* Patients aged 35-70 years.
* Both male and female with Type II diabetes.
* Overt proteinuria defined by urinary albumin excretion \> 300 mg/24 hr. in 2 consecutive determinations despite treatment with highest FDA recommended doses of an angiotensin converting enzyme inhibitor or angiotensin receptor blocker for at least 6 months.
* Treatment of hyperglycemia with (but not limited to) an oral hypoglycemic agent or insulin (If a SGLT2 inhibitors is used, stable dose for at least 3 months).
* Treatment of hypercholesterolemia with (but not limited to) one medication from the class statins.
* Patients using stable dose of Non-Dihydropyridine Calcium Channel Blockers for at least 6 months as antihypertensive.
* Presence of diabetic retinopathy.
* Signing informed consent.
Exclusion Criteria:
* Type I diabetes.
* Advanced chronic kidney disease defined by estimated GFR \< 30 ml/min/1.73 m2
* Severely uncontrolled diabetes defined by HbA1C \> 10%.
* Uncontrolled hypertension defined by SBP \>140 mmHg or DBP \>90 mmHg despite antihypertensive therapy.
* Patients with organ transplant history.
* Secondary forms of hypertension with defined etiology other than diabetes mellitus.
* Other renal diseases.
* Chronic Heart Failure with NYHA class III or IV.
* Active infection.
* Pregnancy.
Use of one of the following medications within 2 months prior to enrollment in the study:
* Non-steroidal anti-inflammatory agents.
* Antioxidants supplements including vitamin E, vitamin C, N-acetyl- cysteine (NAC), Pentoxifylline, Lipoic acid, Fish-oil extracts (omega-3 fatty acids), Soy extracts (isoflavones), Green-tea preparations, Pomegranate extracts, Grape extracts.
* Active malignancy.
* History of drug or alcohol dependency.
* Psychiatric or neurological condition, preventing aware consent to the study and/or adherence to the study protocol.
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
35 Years
Maximum Age:
70 Years
Study:
NCT06425705
Study Brief:
Protocol Section:
NCT06425705