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The aim of this study is to evaluate the safety and effects of resveratrol in treatment of diabetic nephropathy.
Diabetes mellitus (DM) is one of the most important public health burdens, and its prevalence has rapidly increased worldwide over the past decades. One of the most important complications of DM is nephropathy.
Resveratrol (3, 5, 4'-trihydroxystilbene) is a natural polyphenolic compound belongs to the large group of polyphenols found in different plant species. The richest natural source of resveratrol is Polygonum cuspidatum - a plant root extract of which have been used in oriental folk medicine. Considerable amounts of resveratrol were also found in skin of red grapes, peanuts, groundnuts, and red vine.
Resveratrol is considered to have beneficial effects on glucose tolerance and insulin sensitivity, the cardiovascular system, as it has been found to improve vasodilatation, ischaemic preconditioning, both of which seem to be the result of the activation of the endothelial NO synthase enzyme, and to inhibit both platelet aggregation and vascular smooth muscle cell proliferation. Resveratrol itself is an efficient antioxidant, as evidenced by both in vitro and in vivo studies, and, it has also been shown to improve diabetes-related impairments in animals.
We hypothesized that resveratrol may have a favorable effects on control of diabetic nephropathy. The aim of this study is to evaluate the safety and effects of resveratrol in treatment of diabetic nephropathy.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Resveratrol | Experimental | Resveratrol + Losartan |
|
| Placebo | Placebo Comparator | Placebo + Losartan |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Resveratrol | Drug | Resveratrol 500mg daily |
| |
| Placebo |
| Measure | Description | Time Frame |
|---|---|---|
| Urine albumin level | 3 months | |
| Serum creatinin | 3 months |
| Measure | Description | Time Frame |
|---|---|---|
| Fasting blood sugar (FBS) | 3 months | |
| Glycosylated hemoglobin (A1C) | 3 months | |
| Liver aminotransferases (ALT and AST) |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Gholamhossein Ranjbar Omrani, MD | Endocrine and Metabolism Research Center, Shiraz University of Medical Sciences | Study Chair |
| Jamshid Roozbeh, MD | Shiraz Nephrology and Urology Research Center, Shiraz University of Medical Sciences | Principal Investigator |
| Azar Sattarinejad, MD | Endocrine and Metabolism Research Center, Shiraz University of Medical Sciences | Principal Investigator |
| Mesbah Shams, MD | Endocrine and Metabolism Research Center, Shiraz University of Medical Sciences | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Shahid Motahhari Clinic, Shiraz University of Medical Sciences | Shiraz | Fars | Iran |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 37916745 | Derived | Colombijn JM, Hooft L, Jun M, Webster AC, Bots ML, Verhaar MC, Vernooij RW. Antioxidants for adults with chronic kidney disease. Cochrane Database Syst Rev. 2023 Nov 2;11(11):CD008176. doi: 10.1002/14651858.CD008176.pub3. | |
| 29983230 | Derived | Sattarinezhad A, Roozbeh J, Shirazi Yeganeh B, Omrani GR, Shams M. Resveratrol reduces albuminuria in diabetic nephropathy: A randomized double-blind placebo-controlled clinical trial. Diabetes Metab. 2019 Jan;45(1):53-59. doi: 10.1016/j.diabet.2018.05.010. Epub 2018 Jun 8. |
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| ID | Term |
|---|---|
| D003928 | Diabetic Nephropathies |
| D003920 | Diabetes Mellitus |
| D048909 | Diabetes Complications |
| D011507 | Proteinuria |
| D000419 | Albuminuria |
| D051437 | Renal Insufficiency |
| ID | Term |
|---|---|
| D007674 | Kidney Diseases |
| D014570 | Urologic Diseases |
| D052776 | Female Urogenital Diseases |
| D005261 | Female Urogenital Diseases and Pregnancy Complications |
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| ID | Term |
|---|---|
| D000077185 | Resveratrol |
| D019808 | Losartan |
| ID | Term |
|---|---|
| D000081225 | Stilbestrols |
| D013267 | Stilbenes |
| D001597 | Benzylidene Compounds |
| D001555 | Benzene Derivatives |
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| Drug |
Placebo 1 capsule daily |
|
| Losartan | Drug | Losartan 12.5mg daily |
|
| 3 months |
| Serum insulin level | 3 months |
| Number of patients with adverse events | 3 months |
| D000091642 | Urogenital Diseases |
| D052801 | Male Urogenital Diseases |
| D004700 | Endocrine System Diseases |
| D044882 | Glucose Metabolism Disorders |
| D008659 | Metabolic Diseases |
| D009750 | Nutritional and Metabolic Diseases |
| D014555 | Urination Disorders |
| D020924 | Urological Manifestations |
| D012816 | Signs and Symptoms |
| D013568 | Pathological Conditions, Signs and Symptoms |
| D006841 |
| Hydrocarbons, Aromatic |
| D006844 | Hydrocarbons, Cyclic |
| D006838 | Hydrocarbons |
| D009930 | Organic Chemicals |
| D059808 | Polyphenols |
| D010636 | Phenols |
| D001713 | Biphenyl Compounds |
| D007093 | Imidazoles |
| D001393 | Azoles |
| D006573 | Heterocyclic Compounds, 1-Ring |
| D006571 | Heterocyclic Compounds |
| D013777 | Tetrazoles |