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

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Clinical Phase

PHASE2

Total Enrollment

100 participants

Study Classification

INTERVENTIONAL

Study Start Date

2016-05-31

Study Completion Date

2017-05-31

Brief Summary

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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.

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Detailed Description

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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.

Conditions

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Proteinuria

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

DOUBLE

Participants Investigators

Study Groups

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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.

Group Type EXPERIMENTAL

Curcumin

Intervention Type DIETARY_SUPPLEMENT

Placebo

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

Group Type PLACEBO_COMPARATOR

Placebo

Intervention Type OTHER

Interventions

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Curcumin

Intervention Type DIETARY_SUPPLEMENT

Placebo

Intervention Type OTHER

Other Intervention Names

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Tumeric

Eligibility Criteria

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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

Minimum Eligible Age

18 Years

Maximum Eligible Age

80 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No