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NCT Number: NCT01003236

Evaluating the Renoprotective Effect of Milk Thistle Extract on Patients With Type II Diabetic Nephropathy

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 lead to the activation of stress-sensitive intracellular signaling pathways, causing cellular damage and late complications of diabetes including renal injury. Although the investigators understanding of how hyperglycemia-induced oxidative stress ultimately leads to tissue damage has advanced considerably in recent years, effective therapeutic strategies to prevent or delay the development of this damage remain limited. The flavonoid complex silymarin, an extract from the milk thistle, and its major pharmacological active component silibinin are free radical scavengers and potent membrane stabilizers by preventing lipid peroxidation. Furthermore, during early stages of diabetes, flavonoids minimize oxidative stress, and inflammation which represent important factors in the development of diabetic nephropathy.

In this study the investigators plan to evaluate the renoprotective effect of milk thistle extract on type II diabetic patients with kidney disease.

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Key information

Conditions

Diabetic Nephropathy Diabetes Complications Diabetes Mellitus Diabetes Mellitus, Type 2 Diabetic Nephropathies Endocrine System Diseases Female Urogenital Diseases Female Urogenital Diseases and Pregnancy Complications Glucose Metabolism Disorders Kidney Diseases Male Urogenital Diseases Metabolic Diseases Nutritional and Metabolic Diseases Urogenital Diseases Urologic Diseases

Age range

30 year–70 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 2

Primary location

Motahari Clinic

Shiraz, Fars, 71345, Iran

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • 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 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 >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

Treatment and study plan

Placebo

Drug

140 mg placebo tablets, 3 times per day for 3 months

Milk Thistle extract

Drug

1 tablet equal to 140mg silymarin administered 3 times a day for 3 months

Other names: Livergol made by Goldaru Pharmaceutical Company (Iran)

Primary outcomes

  1. Change from baseline in urinary albumin-creatinine ratio

    Time frame: 3 month

Secondary outcomes

  1. Change from baseline in urinary TNF-α

    Time frame: 3 month

  2. Change from baseline in urinary TGF-β

    Time frame: 3 month

  3. Change from baseline in fasting plasma glucose

    Time frame: 3 month

  4. Change from baseline in blood lipid profile

    Time frame: 3 month

  5. Change from baseline in hemoglobin A1C

    Time frame: 3 month

  6. Change from baseline in urinary MDA

    Time frame: 3 month

  7. Change from baseline in serum TNF-α

    Time frame: 3 month

  8. Change from baseline in serum TGF-β

    Time frame: 3 month

  9. Change from baseline in serum MDA

    Time frame: 3 month

  10. Change from baseline in estimated GFR

    Time frame: 3 month

  11. Change from baseline in serum creatinine

    Time frame: 3 month

Sponsors and collaborators

Lead sponsor

Shiraz University of Medical Sciences

Other

Registry information

Official study title

Evaluating the Preventive Effect of Milk Thistle Extract (Silymarin) on Progression of Diabetic Nephropathy, a Randomized, Double-blind, Placebo-controlled Clinical Trial.

Important dates

Study start
2010
Primary completion
2011
Study completion
2011
First posted
Oct 28, 2009
Registry last updated
Jun 25, 2012

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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