Status:
COMPLETED
Evaluating the Renoprotective Effect of Milk Thistle Extract on Patients With Type II Diabetic Nephropathy
Lead Sponsor:
Shiraz University of Medical Sciences
Conditions:
Diabetic Nephropathy
Eligibility:
All Genders
30-70 years
Phase:
PHASE2
Brief Summary
There is considerable evidence that increased blood glucose results in the generation of reactive oxygen species, ultimately leading to increased oxidative stress in a variety of tissues. This may lea...
Eligibility Criteria
Inclusion
- 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 thiazolidinedione is used, stable dose for at least 6 months)
- Treatment of hypercholesterolemia with (but not limited to) one medication from the class statins
- Presence of diabetic retinopathy
- Signing informed consent
Exclusion
- 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 \>160 mmHg or DBP \>100 mmHg despite antihypertensive therapy
- Secondary forms of hypertension with defined etiology other than diabetes mellitus
- Other renal diseases
- History of solid organ transplantation
- 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), Pentoxyfilline, Lipoic acid, Fish-oil extracts (omega-3 fatty acids), Soy extracts (isoflavones), Green-tea preparations, Pomegranate extracts, Grape extracts
- Active malignancy
- Hepatitis virus or Human Immunodeficiency virus infections
- History of drug or alcohol dependency
- Cigarette smoking
- Psychiatric or neurological condition, preventing aware consent to the study and/or adherence to the study protocol
Key Trial Info
Start Date :
October 1 2010
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
November 1 2011
Estimated Enrollment :
60 Patients enrolled
Trial Details
Trial ID
NCT01003236
Start Date
October 1 2010
End Date
November 1 2011
Last Update
June 25 2012
Active Locations (1)
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1
Motahari Clinic
Shiraz, Fars, Iran, 71345