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Correction of Glutathione Deficiency for Treatment of Diabetic Nephropathy (CGDN)
The study is done to find out whether the combined use of the nutritional supplements N-acetylcysteine and Siliphos (milk thistle extract) corrects the shedding of urine protein and oxidative damage (damage to cells and organs often compared to fast aging) in patients with Type 2 Diabetes Mellitus (T2DM) and diabetic kidney disease.
Details
| Lead sponsor | VA Office of Research and Development |
|---|---|
| Phase | Phase 2 |
| Status | COMPLETED |
| Enrolment | 108 |
| Start date | 2011-01 |
| Completion | 2016-12 |
Conditions
- Diabetic Nephropathy
- Proteinuria
- Oxidative Stress
Interventions
- N-acetylcysteine placebo and silibin placebo
- N-acetylcysteine active and silibin placebo
- N-acetylcysteine placebo and silibin active
- N-acetylcysteine active and silibin active
- N-acetylcysteine active + high-dose silibin active
Primary outcomes
- Change From Baseline in Urinary Albumin Excretion — Baseline and 3 months
Urine albumin to creatinine ratio was assessed at the end of run in period and after 3 months administration of study intervention.
Countries
United States