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

Phase 2

• Conditions: Proteinuria
• Interventions: Other: Placebo; Dietary Supplement: Curcumin

• Registration Number: NCT03019848
• Lead Sponsor: Instituto Nacional de Cardiologia Ignacio Chavez

Brief 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.

Detailed 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.

Study Timeline

• Study Start: 2016-05
• Status Verified: 2016-09
• Study First Submitted: 2016-09-12
• Study First Submitted QC: 2017-01-11
• Last Update Submitted: 2017-01-11
• Study First Posted: 2017-01-13
• Last Update Posted: 2017-01-13
• Primary Completion: 2017-05
• Study Completion: 2017-05

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 100

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

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Placebo	Placebo	The control group will receive 7-capsules/ day identical in color and size, containing placebo for 6 months.
Curcumin	Curcumin	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.

Primary Outcome Measures

Name	Time	Method
Urine protein excretion	24 weeks	Quantify proteinuria and adjust based in creatinuria, before and after the treatment. ( Units: g/g).

Secondary Outcome Measures

Name	Time	Method
Malondialdehyde (MDA)	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	6 months	Enzyme-linked immunoassay (ELISA) will be use to the measurement of serum TGF-b, IL-10, IL-6 and TNF-a.
Free radical scavenging activity	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.

Trial Locations

Locations (1)

Instituto Nacional de Cardiologia Ignacio Chávez; 🇲🇽 Mexico City, Mexico