Effect of Oral Supplementation With Curcumin in Patients With Proteinuric Diabetic Kidney Disease

Study Overview
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Brief Summary
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The purpose of this study is to determine if the oral supplementation with curcumin reduces proteinuria, improves the redox and pro-inflammatory state in patients with chronic kidney disease associated to Diabetes mellitus.

Detailed Description
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Diabetic Kidney Disease (DKD) represents the fist cause of end-stage kidney disease in Mexico and the world, and it is characterized by the presence of hyperfiltration, glomerular hypertrophy, tubular albuminuria and mesangial matrix expansion, mainly by the oxidative stress and the pro-inflammatory state. Current treatments are limited on controlling proteinuria and delay progression of the disease, but even with an optimal management, a significant number of patient progress to end-stage renal disease. Curcumin, found in the extracts of the rhizome of the plant Curcuma longa L., has a wide spectrum of biological and pharmacological activities, such as anti-oxidant, anti-inflammatory, anti-carcinogenic and anti-diabetic effects. It has the capacity to act directly with highly reactive oxygen species, induce the expression of various cytoprotective proteins through Keap1/Nrf2/ARE pathway and reducing inflammatory transcription factors such as NF-κB and TNF-α. Curcumin could be an adjuvant treatment in the management of DKC due to his pleiotropic nature, low cost and few side effects.

Conditions
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Proteinuria

Intervention / Treatment
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* Dietary Supplement: Curcumin
* Other: Placebo


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Diagnosis of Diabetes Mellitus type 2 and proteinuric kidney disease with 1000 mg of more proteins in daily recollection Glomerular filtration rate between 15-60 mL/min/ 1.73 m2 calculated by CKD-EPI Patients taking Angiotensin II Receptor Blocker or ACE inhibitors Exclusion Criteria: Renal replacement therapy Autoimmune disease or malignancy Pregnancy Hepatic damage Congestive heart failure classification III or IV (NYHA) History of organ transplantation History of chemotherapy or immunosuppression within 2 years prior to screening

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 80 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Curcumin<br>Each patient of this group will receive 1.67 grams of curcumin ( 7 capsules of 231 mg) divided in 3 doses daily for 6 months. | Dietary Supplement: Curcumin<br> <br> * Other names: Tumeric;|
| Placebo Comparator: Placebo<br>The control group will receive 7-capsules/ day identical in color and size, containing placebo for 6 months. | Other: Placebo<br> <br> |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Urine protein excretion | Quantify proteinuria and adjust based in creatinuria, before and after the treatment. ( Units: g/g). | 24 weeks | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Free radical scavenging activity | Free radical scavenging activity in plasma using DPPH, a purple-colored stable free radical is reduced to the yellow-colored diphenyl picryl-hydrazine, and the absorbance will be measure at 518 nm. The results were expressed as percentage of DPPH inhibition. | 6 months | 
| Malondialdehyde (MDA) | Malondialdehyde (MDA) in plasma. We will measure the reaction with 1-methyl-2- phenylindole at 586 nm, using a standard curve of tetrame- thoxypropane. | 6 months | 
| Proinflammatory status | Enzyme-linked immunoassay (ELISA) will be use to the measurement of serum TGF-b, IL-10, IL-6 and TNF-a. | 6 months | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Redox and pro-inflammatory status