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

National Institute of Cardiology Ignacio Chavez

Status and phase: Unknown; Phase 2

Conditions: Proteinuria

Treatments: Dietary Supplement: Curcumin; Other: Placebo

Study type: Interventional

Funder types: Other

Identifiers

NCT03019848

INC.12-793

Details and patient eligibility

About

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.

Full 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.

Enrollment: 100 estimated patients

Sex: All

Ages: 18 to 80 years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Double Blind

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100 participants in 2 patient groups, including a placebo group

Curcumin

Experimental group

Description:

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.

Treatment:

Dietary Supplement: Curcumin

Placebo

Placebo Comparator group

Description:

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

Treatment:

Other: Placebo