Effect of Oral Supplementation With Curcumin in Patients With Proteinuric Diabetic Kidney Disease
|ClinicalTrials.gov Identifier: NCT03019848|
Recruitment Status : Unknown
Verified September 2016 by Magdalena Madero, Instituto Nacional de Cardiologia Ignacio Chavez.
Recruitment status was: Recruiting
First Posted : January 13, 2017
Last Update Posted : January 13, 2017
|Condition or disease||Intervention/treatment||Phase|
|Proteinuria||Dietary Supplement: Curcumin Other: Placebo||Phase 2|
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.
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||100 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||Double (Participant, Investigator)|
|Study Start Date :||May 2016|
|Estimated Primary Completion Date :||May 2017|
|Estimated Study Completion Date :||May 2017|
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
Other Name: Tumeric
Placebo Comparator: Placebo
The control group will receive 7-capsules/ day identical in color and size, containing placebo for 6 months.
- Urine protein excretion [ Time Frame: 24 weeks ]Quantify proteinuria and adjust based in creatinuria, before and after the treatment. ( Units: g/g).
- Free radical scavenging activity [ Time Frame: 6 months ]
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.
- Malondialdehyde (MDA) [ Time Frame: 6 months ]Malondialdehyde (MDA) in plasma. We will measure the reaction with 1-methyl-2- phenylindole at 586 nm, using a standard curve of tetrame- thoxypropane.
- Proinflammatory status [ Time Frame: 6 months ]Enzyme-linked immunoassay (ELISA) will be use to the measurement of serum TGF-b, IL-10, IL-6 and TNF-a.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03019848
|Contact: Magdalena Madero, MD||55-5573-2911 ext firstname.lastname@example.org|
|Contact: Alfonso Gindl, MD||55-5573-2911 ext email@example.com|
|Instituto Nacional de Cardiologia Ignacio Chávez||Recruiting|
|Mexico City, Mexico, 14080|