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

Proteinuria Clinical Trial

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT03019848
• Other study ID #: INC.12-793
• Status: Recruiting
• Phase: Phase 2
• First received: September 12, 2016
• Last updated: January 11, 2017
• Start date: May 2016
• Est. completion date: May 2017

Study information

• Verified date: September 2016
• Source: Instituto Nacional de Cardiologia Ignacio Chavez
• Contact: Magdalena Madero, MD
• Phone: 55-5573-2911
• Email: madero.magdalena[@]gmail.com
• Is FDA regulated: No
• Health authority: Mexico: National Institute of Public Health, Health SecretariatMexico: Secretaria de Salud
• Study type: Interventional

Clinical Trial Summary

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.

Description:

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 100
• Est. completion date: May 2017
• Est. primary completion date: May 2017
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 80 Years

Eligibility

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

Study Design

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Investigator), Primary Purpose: Treatment

Related Conditions & MeSH terms

• Proteinuria

Intervention

Dietary Supplement:
• Curcumin

Other:
• Placebo

Locations

Country	Name	City	State
Mexico	Instituto Nacional de Cardiologia Ignacio Chávez	Mexico City

Sponsors (1)

Lead Sponsor	Collaborator
Instituto Nacional de Cardiologia Ignacio Chavez

Country where clinical trial is conducted

Mexico, 

References & Publications (5)

de Zeeuw D, Remuzzi G, Parving HH, Keane WF, Zhang Z, Shahinfar S, Snapinn S, Cooper ME, Mitch WE, Brenner BM. Proteinuria, a target for renoprotection in patients with type 2 diabetic nephropathy: lessons from RENAAL. Kidney Int. 2004 Jun;65(6):2309-20. — View Citation

Jiménez-Osorio AS, García-Niño WR, González-Reyes S, Álvarez-Mejía AE, Guerra-León S, Salazar-Segovia J, Falcón I, Montes de Oca-Solano H, Madero M, Pedraza-Chaverri J. The Effect of Dietary Supplementation With Curcumin on Redox Status and Nrf2 Activation in Patients With Nondiabetic or Diabetic Proteinuric Chronic Kidney Disease: A Pilot Study. J Ren Nutr. 2016 Jul;26(4):237-44. doi: 10.1053/j.jrn.2016.01.013. — View Citation

Khajehdehi P, Pakfetrat M, Javidnia K, Azad F, Malekmakan L, Nasab MH, Dehghanzadeh G. Oral supplementation of turmeric attenuates proteinuria, transforming growth factor-ß and interleukin-8 levels in patients with overt type 2 diabetic nephropathy: a randomized, double-blind and placebo-controlled study. Scand J Urol Nephrol. 2011 Nov;45(5):365-70. doi: 10.3109/00365599.2011.585622. — View Citation

National Kidney Foundation.. K/DOQI clinical practice guidelines for chronic kidney disease: evaluation, classification, and stratification. Am J Kidney Dis. 2002 Feb;39(2 Suppl 1):S1-266. — View Citation

Trujillo J, Chirino YI, Molina-Jijón E, Andérica-Romero AC, Tapia E, Pedraza-Chaverrí J. Renoprotective effect of the antioxidant curcumin: Recent findings. Redox Biol. 2013 Sep 17;1:448-56. doi: 10.1016/j.redox.2013.09.003. Review. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Urine protein excretion	Quantify proteinuria and adjust based in creatinuria, before and after the treatment. ( Units: g/g).	24 weeks	No
Secondary	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	No
Secondary	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	No
Secondary	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	No