search
Back to results

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

Primary Purpose

Proteinuria

Status
Unknown status
Phase
Phase 2
Locations
Mexico
Study Type
Interventional
Intervention
Curcumin
Placebo
Sponsored by
Instituto Nacional de Cardiologia Ignacio Chavez
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Proteinuria focused on measuring Redox and pro-inflammatory status

Eligibility Criteria

18 Years - 80 Years (Adult, Older Adult)All SexesDoes not accept 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

Sites / Locations

  • Instituto Nacional de Cardiologia Ignacio ChávezRecruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Placebo Comparator

Arm Label

Curcumin

Placebo

Arm 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.

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

Outcomes

Primary Outcome Measures

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

Secondary Outcome Measures

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.
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.
Proinflammatory status
Enzyme-linked immunoassay (ELISA) will be use to the measurement of serum TGF-b, IL-10, IL-6 and TNF-a.

Full Information

First Posted
September 12, 2016
Last Updated
January 11, 2017
Sponsor
Instituto Nacional de Cardiologia Ignacio Chavez
search

1. Study Identification

Unique Protocol Identification Number
NCT03019848
Brief Title
Effect of Oral Supplementation With Curcumin in Patients With Proteinuric Diabetic Kidney Disease
Study Type
Interventional

2. Study Status

Record Verification Date
September 2016
Overall Recruitment Status
Unknown status
Study Start Date
May 2016 (undefined)
Primary Completion Date
May 2017 (Anticipated)
Study Completion Date
May 2017 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Instituto Nacional de Cardiologia Ignacio Chavez

4. Oversight

Data Monitoring Committee
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Proteinuria
Keywords
Redox and pro-inflammatory status

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 2
Interventional Study Model
Parallel Assignment
Masking
ParticipantInvestigator
Allocation
Randomized
Enrollment
100 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Curcumin
Arm Type
Experimental
Arm 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.
Arm Title
Placebo
Arm Type
Placebo Comparator
Arm Description
The control group will receive 7-capsules/ day identical in color and size, containing placebo for 6 months.
Intervention Type
Dietary Supplement
Intervention Name(s)
Curcumin
Other Intervention Name(s)
Tumeric
Intervention Type
Other
Intervention Name(s)
Placebo
Primary Outcome Measure Information:
Title
Urine protein excretion
Description
Quantify proteinuria and adjust based in creatinuria, before and after the treatment. ( Units: g/g).
Time Frame
24 weeks
Secondary Outcome Measure Information:
Title
Free radical scavenging activity
Description
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.
Time Frame
6 months
Title
Malondialdehyde (MDA)
Description
Malondialdehyde (MDA) in plasma. We will measure the reaction with 1-methyl-2- phenylindole at 586 nm, using a standard curve of tetrame- thoxypropane.
Time Frame
6 months
Title
Proinflammatory status
Description
Enzyme-linked immunoassay (ELISA) will be use to the measurement of serum TGF-b, IL-10, IL-6 and TNF-a.
Time Frame
6 months

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
80 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Magdalena Madero, MD
Phone
55-5573-2911
Ext
1262
Email
madero.magdalena@gmail.com
First Name & Middle Initial & Last Name or Official Title & Degree
Alfonso Gindl, MD
Phone
55-5573-2911
Ext
1262
Email
alfonsogindl@hotmail.com
Facility Information:
Facility Name
Instituto Nacional de Cardiologia Ignacio Chávez
City
Mexico City
ZIP/Postal Code
14080
Country
Mexico
Individual Site Status
Recruiting

12. IPD Sharing Statement

Citations:
PubMed Identifier
11904577
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. No abstract available.
Results Reference
background
PubMed Identifier
15149345
Citation
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. doi: 10.1111/j.1523-1755.2004.00653.x.
Results Reference
background
PubMed Identifier
24191240
Citation
Trujillo J, Chirino YI, Molina-Jijon E, Anderica-Romero AC, Tapia E, Pedraza-Chaverri J. Renoprotective effect of the antioxidant curcumin: Recent findings. Redox Biol. 2013 Sep 17;1(1):448-56. doi: 10.1016/j.redox.2013.09.003.
Results Reference
background
PubMed Identifier
21627399
Citation
Khajehdehi P, Pakfetrat M, Javidnia K, Azad F, Malekmakan L, Nasab MH, Dehghanzadeh G. Oral supplementation of turmeric attenuates proteinuria, transforming growth factor-beta 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. Epub 2011 May 31.
Results Reference
background
PubMed Identifier
26915483
Citation
Jimenez-Osorio AS, Garcia-Nino WR, Gonzalez-Reyes S, Alvarez-Mejia AE, Guerra-Leon S, Salazar-Segovia J, Falcon 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. Epub 2016 Feb 22.
Results Reference
background

Learn more about this trial

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

We'll reach out to this number within 24 hrs