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

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ClinicalTrials.gov Identifier: NCT03019848
Recruitment Status : Recruiting
First Posted : January 13, 2017
Last Update Posted : January 13, 2017
Information provided by (Responsible Party):
Magdalena Madero, 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.

Condition or disease Intervention/treatment Phase
Proteinuria Dietary Supplement: Curcumin Other: Placebo Phase 2

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 Type : Interventional  (Clinical Trial)
Estimated Enrollment : 100 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary Purpose: Treatment
Study Start Date : May 2016
Estimated Primary Completion Date : May 2017
Estimated Study Completion Date : May 2017

Arm Intervention/treatment
Experimental: 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.
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.
Other: Placebo

Primary Outcome Measures :
  1. Urine protein excretion [ Time Frame: 24 weeks ]
    Quantify proteinuria and adjust based in creatinuria, before and after the treatment. ( Units: g/g).

Secondary Outcome Measures :
  1. 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.

  2. 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.

  3. 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.

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Ages Eligible for Study:   18 Years to 80 Years   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03019848

Contact: Magdalena Madero, MD 55-5573-2911 ext 1262 madero.magdalena@gmail.com
Contact: Alfonso Gindl, MD 55-5573-2911 ext 1262 alfonsogindl@hotmail.com

Instituto Nacional de Cardiologia Ignacio Chávez Recruiting
Mexico City, Mexico, 14080
Sponsors and Collaborators
Instituto Nacional de Cardiologia Ignacio Chavez


Responsible Party: Magdalena Madero, MD, Chief of the Nephrology Department, Instituto Nacional de Cardiologia Ignacio Chavez
ClinicalTrials.gov Identifier: NCT03019848     History of Changes
Other Study ID Numbers: INC.12-793
First Posted: January 13, 2017    Key Record Dates
Last Update Posted: January 13, 2017
Last Verified: September 2016

Keywords provided by Magdalena Madero, Instituto Nacional de Cardiologia Ignacio Chavez:
Redox and pro-inflammatory status

Additional relevant MeSH terms:
Urination Disorders
Urologic Diseases
Urological Manifestations
Signs and Symptoms
Anti-Inflammatory Agents, Non-Steroidal
Analgesics, Non-Narcotic
Sensory System Agents
Peripheral Nervous System Agents
Physiological Effects of Drugs
Anti-Inflammatory Agents
Antirheumatic Agents
Antineoplastic Agents
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action