Oxidative Stress Clinical Trial
Official title:
N-Acetylcysteine and Milk Thistle for Treatment of Diabetic Nephropathy.
The study is designed to test if the combination of two potent antioxidant nutritional supplements, N-acetylcysteine and the milk thistle extract silibin, is capable of correcting the shedding of urine protein, the oxidative stress, and the inflammation in patients with type 2 diabetes mellitus and diabetic kidney disease.
Status | Completed |
Enrollment | 114 |
Est. completion date | April 2016 |
Est. primary completion date | April 2016 |
Accepts healthy volunteers | No |
Gender | Both |
Age group | 18 Years to 70 Years |
Eligibility |
Inclusion Criteria: - Males or females, age 18-70 years old. - Type 2 diabetes mellitus - Diabetic nephropathy, as defined by: - estimated GFR between 60 and 15 ml/min, - presence of proteinuria. - Current medical treatment with low dose aspirin - Treatment of hypertension with (but not limited to) one diuretic, one beta- blocker and one medication from the classes ARBs or ACE inhibitors. - Treatment of hyperglycemia with (but not limited to) glipizide and the medication class insulin. - Treatment of hypercholesterolemia with (but not limited to) one medication from the class statins. Exclusion Criteria: - Type 1 diabetes mellitus. - Glycosylated hemoglobin (HbA1C) > 10% - >20% variation in estimated GFR, during last 6 months - SBP >170 mmHg or DBP >100 mmHg on medications - Other secondary forms of hypertension (endocrine, renovascular) - History of intolerance to: - Both ACE-I and ARBs; - The investigational supplements; - Iodinated radiologic contrast material. - Known non diabetic renal disease, or history of solid organ transplantation. - Hepatitis virus or Human Immunodeficiency virus infections - Use of one of the following medications within 2 months prior to enrollment in the study: - Metformin. - Thiazolidinediones (pioglitazone or rosiglitazone); - Prescription-grade vitamin E, vitamin C, systemic steroids, and/or non-steroidal anti-inflammatory agents; - Over-the-counter vitamin E, vitamin C, and/or non-steroidal anti-inflammatory agents. - Over-the-counter antioxidants supplements including: Lipoic acid, Coenzyme Q10, N-acetyl-cysteine (NAC), Glutathione (GSH), Chromium, Fish-oil extracts (omega-3 fatty acids), Soy extracts (isoflavones), Milk thistle extract (silymarin), Green-tea preparations, Pomegranate extracts, Grape extracts, and Prickly pear extract. - Active coronary artery disease or cerebral vascular disease within 3 months prior to signing the informed consent. - Hepatic dysfunction as defined by abnormal total bilirubin or liver enzymes (ALT, AST) >2 times upper limit of normal range. - 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 - Unwillingness to practice birth control throughout the study. - Participation to another clinical study within 1 month prior to signing the informed consent form. - Planned move to outside the study area, surgery or radiographic studies utilizing iodine-based contrast material within the next one year |
Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Primary Purpose: Treatment
Country | Name | City | State |
---|---|---|---|
United States | University of Texas Hlth Sci Ctr San Ant | San Antonio | Texas |
Lead Sponsor | Collaborator |
---|---|
The University of Texas Health Science Center at San Antonio | National Center for Complementary and Integrative Health (NCCIH), VA Office of Research and Development |
United States,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Urinary Albumin excretion | 3-month | No | |
Secondary | urinary alpha-1 microglobulin excretion | 3-month | No | |
Secondary | urinary C-C-chemokines excretion | 3-month | No | |
Secondary | peripheral blood monocyte glutathione content | 3-month | No | |
Secondary | tolerance and safety | 3-month | Yes |
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