Chronic Kidney DiseasesPhase 2/3CURCUNRF2NCT03262363
Curcumin on NFE2L2 Gene Expression, Antioxidant Capacity and Renal Function According to rs35652124 in Diabetic Nephropathy
A Phase 2/3 study testing Curcumin/NFE2L2 A>G in people with Chronic Kidney Diseases and Diabetes Mellitus, Type 2, run by Unidad de Investigacion Medica en Enfermedades Renales at 1 site in Mexico.
Trial summary
The increase in the prevalence of diabetes mellitus (DM) is one of the greatest public health challenges worldwide. Epidemiological studies have shown that DM is the leading cause of chronic kidney disease (CKD) in patients initiating renal replacement therapy. Read more about this study
- Who is it for?
- Ages 18 to 90 years
- Conditions the study is for
- Chronic Kidney Diseases, Diabetes Mellitus, Type 2, Polymorphism
- What is being tested?
- Curcumin/NFE2L2 A>G
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 176 participants
- Where
- 1 siteMexico
- Study dates
- 1 Aug 2018to 30 Apr 2019
- Phase
- Phase 2/3
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 90 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- With T2DM according to the American Diabetes Association
- With any time of T2DM evolution
- With CKD stage 1-3a according to the K/DIGO guidelines
Who cannot join
- Incomplete evaluations
- That they have not been attached to the assigned intervention with an established frequency of <80%
- Decide to withdraw from the study
Trial locations and contacts
1 site in 1 country.
Mexico1 site
Umae Hospital de Especialidades
Guadalajara, Jalisco, 44340
LAURA CORTES-SANABRIA, PhD, 33 3660 3000 ext. 32204, cortes_sanabria@yahoo.com.mx
ERIKA FABIOLA GOMEZ-GARCIA, MsC, 33 3660 3000 ext. 32204, erikaf.gomezg@yahoo.com.mx
About this study
Official title: Interaction of Polymorphism rs35652124 With Curcumin Supplementation on NFE2L2 Gene Expression, Antioxidant Capacity and Renal Function in Patients With Early Diabetic Nephropathy
The increase in the prevalence of diabetes mellitus (DM) is one of the greatest public health challenges worldwide. Epidemiological studies have shown that DM is the leading cause of chronic kidney disease (CKD) in patients initiating renal replacement therapy. In our country, diabetes accounts for about 60% of all incidents of dialysis. On the other hand, CKD is currently considered a noxious disease because patients not only have the likelihood of progression to end-stage renal disease (ESRD), but because these renal alterations are associated with an increased risk of cardiovascular complications and premature death for the same cause. Most studies have focused on traditional risk factors (poor diet, physical inactivity and obesity) for the development and progression of renal damage, and less information exists on non-traditional factors such as oxidative stress and mainly, the low antioxidant response that characterizes both DM and nephropathy. In addition, there is a great variation in the susceptibility to and progression of kidney disease between different populations that is not explained by the presence of traditional factors and that could be triggered by genetic variations and its interaction with other components related to the environment and lifestyle. Fortunately, there is sufficient scientific evidence that early detection and modification of negative lifestyle factors can not only delay or halt the progression of the renal function decline to ESRD but can also significantly reduce the incidence of cardiovascular disease leading to premature death in most of these patients. Therefore, it is suggested that this risk may be determined by the interaction of lifestyle factors with the presence of susceptibility alleles, which may vary from one population to another. It is now known that hyperglycemia causes a state of oxidative stress and inflammation that can be counteracted by diet supplementation with some natural antioxidants such as curcumin. It has been shown that this molecule has multiple pharmacological properties: antioxidant, anti-inflammatory, cardioprotective, renoprotective, among others. In clinical trials a positive effect of curcumin has been seen in the treatment of diabetes and its complications. This has generated a relative optimism in the search for new curcumin treatment targets where oxidative stress is of great relevance, as is the case with CKD. However, there are still doubts about its efficacy as an adjuvant in the prevention of CKD. Additionally, the role played by interindividual variability in genes involved in the mechanism of action of curcumin is still incipient, more studies in this knowledge area are necessary.
Read the detailed description
Aim: To evaluate the interaction between rs35652124 polymorphism and curcumin supplementation on the levels of NFE2L2 gene expression, antioxidant capacity and renal function in patients with early diabetic nephropathy (EDN).
Subjects and Methods. Parallel clinical trial with randomized and triple blind. From a database of diabetic patients newly diagnosed with CKD, those with EDN will be identified and located by telephone to complete a total of 275 subjects over 18 years of age. Subsequently, they will be cited in the office of Biomedical Unit 02, will verify that they meet the selection criteria, will be informed about the objectives of the study and invited to participate. Those who agree to participate will be given an informed consent letter, they will be asked to read it carefully and if they have any doubts, they will be clarified at the moment. Once they have signed the written consent they will be cited for the first blood sample collecting (5 mL) to be used for genomic DNA extraction and genotyping for the rs35652124 polymorphism. All patients entering the study will undergo a physical and dietary examination and will record the data on a clinical record card. They will be prescribed a meal plan according to ADA recommendations and K/DOQI guidelines two weeks prior (week <2) at the start of the clinical trial, which will be maintained throughout the follow-up. They will then be scheduled monthly for medical and nutritional assessment. At the visits of weeks 2, 0 (start of supplementation), 12, and 24, three peripheral blood tubes (5 mL each) will be drawn. The first, to extract total mRNA and expression analysis of the NFE2L2 gene, the second, to determine the levels of NRF2, SOD, GPx and HO1 and the third, to perform renal function tests and control of possible confounding variables (creatinine, glucose, glycosylated hemoglobin, lipid profile and uric acid). In addition, they will be asked to collect a sample of the first morning urine to quantify albuminuria/creatinuria on the same day that blood samples were taken. The time of the study since the first evaluation is 26 weeks and the total number of medical and nutrition visits will be six, one monthly. Genotyping will be performed by polymerase chain reaction (PCR) coupled to four pairs of oligonucleotide primers specific for the alleles of interest. The gene expression assay will be performed by real-time PCR, while the determination of the concentrations of NRF2, SOD, GPx and HO1 will be carried out by the ELISA method with kits designed for this purpose. The analysis of the data includes descriptive statistics expressed in averages and standard or median deviations according to the parametric or non-parametric distribution, the nominal variables will be presented as numbers or percentages and the comparison between these will be by Chi square or Fisher exact. Inferential statistics included U-Mann Whitney or Student t tests for independent and paired samples as appropriate to evaluate the NRF2, SOD, GPx and HO1 concentrations with the different interventions and the individuals in the control group. A covariance analysis will be performed taking into consideration the factor supplementation, genetic factor and the interaction of both with the concentrations of NRF2. A value of p<0.05 and 95% CI will be considered significant.
Resources and infrastructure. The CIBO and the Medical Research Unit in Renal Diseases have the human resources to coordinate and develop the present research. Also, they have the necessary infrastructure and equipment to carry out the procedures contemplated in this project. The project will be submitted to calls for funding to obtain the necessary resources for its development.
- Being tested
- Curcumin/NFE2L2 A>G, Placebo/NFE2L2 A>G
- Keywords
- nutrigenomics, Diet-gene interaction,, Curcumin,, Antioxidants,, Human NFE2L2 protein,, Polymorphism,, Diabetes,, Chronic kidney disease
- Medical subject headings
- Renal Insufficiency, Chronic, Diabetes Mellitus, Type 2, Diabetes Mellitus
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Curcumin/NFE2L2 A>GCombination product
Also called Curcumin group
The administration will be orally and the patient will be instructed to take two capsules per day for one week, one in the morning 15 minutes before breakfast and another at night 15 minutes before dinner, accompanied by a cup of 240 mL of pure water. It will be indicated to continue with their usual medical treatment.
Placebo/NFE2L2 A>GCombination product
Also called Placebo group
The administration will be orally and the patient will be instructed to take two capsules for 24 weeks, one in the morning 15 minutes before breakfast and another in the evening 15 minutes before dinner, accompanied by a 240 mL cup of pure water. They will be advised to continue their usual medical treatment.
| Study group | Role | What they receive |
|---|---|---|
| Curcumin/NFE2L2 A>G | Experimental | Patients in Experimental group 1 and 2 will receive 800 mg/day of curcumin (for which a bioavailability of about 90% has been demonstrated and greater than other curcuminoids, administered in two doses of 400 mg each (the presentation will be in capsules containing 400 mg of THC). Receives: Combination Product: Curcumin/NFE2L2 A>G |
| Placebo/NFE2L2 A>G | Placebo comparator | Patients in control group 1 and 2, the placebo intervention will consist of administering sucralose capsules (a substance lacking pharmacological action, with no active principle and a lower intake of glucose compared to sucrose). Patients will receive 300 mg/day of sucralose distributed in two doses of 150 mg each. Receives: Combination Product: Placebo/NFE2L2 A>G |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change from Baseline expression Gen NFE2L2 at 3 months
mRNA and active protein NRF2
Measured: Baseline at 3 months
Change from Baseline expression Gen NFE2L2 at 6 months
mRNA and active protein NRF2
Measured: Baseline at 6 months
Change from Antioxidant capacity at 3 months
Superoxide dismutase, hemoxygenase 1, Glutathion peroxidase using the ELISA technique
Measured: Baseline at 3 months
Change from Antioxidant capacity at 6 months
Superoxide dismutase, hemoxygenase 1, Glutathion peroxidase using the ELISA technique
Measured: Baseline at 6 months
Change from Renal Function at 3 months
Glomerular Filtration Rate (Serum creatinine) and Albuminuria (Albumin/Creatinine Ratio)
Measured: Baseline at 3 months
Change from Renal Function at 6 months
Glomerular Filtration Rate (Serum creatinine) and Albuminuria (Albumin/Creatinine Ratio)
Measured: Baseline at 6 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted25 Aug 2017
- Study start1 Aug 2018 (estimated)
- Primary completion28 Feb 2019 (estimated)
- Study completion30 Apr 2019 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (15)Papers the sponsor has linked to this study.
- Other trials for Chronic Kidney DiseasesStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 2/3
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- The study starts from the classification of patients according to the genotype for the rs35652124 polymorphism (-653G\>A) of the NFE2L2 gene. Two Experimental groups and two Control groups will be formed according to the following: Experimental group 1: Diabetic patients with early CKD homozygous for the -653G (G/G) allele of the NFE2L2 gene that will receive curcumin. Experimental group 2: Diabetic patients with early CKD carrying the allele -653A (G/A or A/A) of the NFE2L2 gene that will receive curcumin. Control group 1: Diabetic patients with early CKD homozygous for the -653G (G/G) allele of the NFE2L2 gene receiving placebo. Control group 2: Diabetic patients with early CKD carrying the allele -653A (G/A or A/A) of the NFE2L2 gene who will receive placebo.
- Masking
- Triple blind
- Who is masked
- Participant, Care provider, Investigator
- Enrolment
- 176 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Unidad de Investigacion Medica en Enfermedades Renales
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03262363
- Sponsor's protocol ID
- UIMER002
- Acronym
- CURCUNRF2
- Status last verified
- Sep 2017
- First submitted
- 18 Aug 2017
- Last updated
- 30 May 2018
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Publications
United States Renal Data Sytem. 2016 USRDS annual data report: Epidemiology of kidney disease in the United States. National Institutes of Health, National Institute of Diabetes and Digestive and Kidney Diseases. Bethesda, MD, 2016.
Gutiérrez JP, Rivera Dommarco J, Shamah Levy T, et al. Encuesta Nacional de Salud y Nutrición 2012. Resultados Nacionales. Cuernavaca, México: Salud Publica Mex; 2012.
Hernández Ávila M, Gutiérrez JP, editores. Diabetes mellitus: la urgencia de reforzar la respuesta en políticas públicas para su prevención y control. Cuernavaca, México: Salud Publica Mex; 2012.
Asociación Latinoamericana de Diabetes (ALAD). Guías ALAD sobre el diagnóstico, control y tratamiento de la diabetes mellitus Tipo 2 con medicina basada en evidencia. 1a ed. Latinoamérica: ALAD; 2013.
Hernández Ávila M, Rivera Dommarco J, Shamah Levy T. Encuesta Nacional de Salud y Nutrición 2016. Resultados Nacionales. Cuernavaca, México: Instituto Nacional de Salud Pública (MX), 2016.
Cueto Manzano AM, Cortés Sanabria L, Martínez Ramírez HR, et al. Enfermedad Renal Crónica Temprana: Prevención, diagnóstico y tratamiento. México: Médica Panamericana; 2013. pp. 250.
Wolf G. New insights into the pathophysiology of diabetic nephropathy: from haemodynamics to molecular pathology. Eur J Clin Invest. 2004 Dec;34(12):785-96. doi: 10.1111/j.1365-2362.2004.01429.x.
PubMed 15606719Navarro JF, Milena FJ, Mora C, Leon C, Garcia J. Renal pro-inflammatory cytokine gene expression in diabetic nephropathy: effect of angiotensin-converting enzyme inhibition and pentoxifylline administration. Am J Nephrol. 2006;26(6):562-70. doi: 10.1159/000098004. Epub 2006 Dec 13.
PubMed 17167242Uruno A, Furusawa Y, Yagishita Y, Fukutomi T, Muramatsu H, Negishi T, Sugawara A, Kensler TW, Yamamoto M. The Keap1-Nrf2 system prevents onset of diabetes mellitus. Mol Cell Biol. 2013 Aug;33(15):2996-3010. doi: 10.1128/MCB.00225-13. Epub 2013 May 28.
PubMed 23716596Gómez García EF, Martínez Ramírez HR, Cortés Sanabria L, et al. Cambios y mejoras en la calidad de la dieta en pacientes con enfermedad renal crónica temprana. En: Conferencia dentro del marco del XLVII Congreso Nacional de Nefrología; 2013 Sep 4-12; Guadalajara, Jalisco. México.
Balagopal P, George D, Patton N, Yarandi H, Roberts WL, Bayne E, Gidding S. Lifestyle-only intervention attenuates the inflammatory state associated with obesity: a randomized controlled study in adolescents. J Pediatr. 2005 Mar;146(3):342-8. doi: 10.1016/j.jpeds.2004.11.033.
PubMed 15756217Ruiz S, Pergola PE, Zager RA, Vaziri ND. Targeting the transcription factor Nrf2 to ameliorate oxidative stress and inflammation in chronic kidney disease. Kidney Int. 2013 Jun;83(6):1029-41. doi: 10.1038/ki.2012.439. Epub 2013 Jan 16.
PubMed 23325084Yoh K, Hirayama A, Ishizaki K, Yamada A, Takeuchi M, Yamagishi S, Morito N, Nakano T, Ojima M, Shimohata H, Itoh K, Takahashi S, Yamamoto M. Hyperglycemia induces oxidative and nitrosative stress and increases renal functional impairment in Nrf2-deficient mice. Genes Cells. 2008 Nov;13(11):1159-70. doi: 10.1111/j.1365-2443.2008.01234.x.
PubMed 19090810Choi BH, Kang KS, Kwak MK. Effect of redox modulating NRF2 activators on chronic kidney disease. Molecules. 2014 Aug 20;19(8):12727-59. doi: 10.3390/molecules190812727.
PubMed 25140450Atul A and Lakhwinder S. Pathogenesis of diabetic nephropathy and potential therapeutic effect of curcumin: A Review. Int J Pharm Bio Sci 2013;4:79-87.
Study at a glance
From the registry record, last updated by the sponsor on 30 May 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Interaction of Polymorphism rs35652124 With Curcumin Supplementation on NFE2L2 Gene Expression, Antioxidant Capacity and Renal Function in Patients With Early Diabetic Nephropathy
- ClinicalTrials.gov ID
- NCT03262363
- Acronym / sponsor ID
- CURCUNRF2 / UIMER002
- Keywords
- nutrigenomics, Diet-gene interaction,, Curcumin,, Antioxidants,, Human NFE2L2 protein,, Polymorphism,, Diabetes,, Chronic kidney disease
- Phase
- Phase 2/3
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 176 participants (estimated)
- Lead sponsor
- Unidad de Investigacion Medica en Enfermedades RenalesUniversity, hospital or other
- Study start
- 1 Aug 2018 (estimated)
- Primary completion
- 28 Feb 2019 (estimated)
- Study completion
- 30 Apr 2019 (estimated)
- First posted
- 25 Aug 2017 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The increase in the prevalence of diabetes mellitus (DM) is one of the greatest public health challenges worldwide. Epidemiological studies have shown that DM is the leading cause of chronic kidney disease (CKD) in patients initiating renal replacement therapy. In our country, diabetes accounts for about 60% of all incidents of dialysis. On the other hand, CKD is currently considered a noxious disease because patients not only have the likelihood of progression to end-stage renal disease (ESRD), but because these renal alterations are associated with an increased risk of cardiovascular complications and premature death for the same cause. Most studies have focused on traditional risk factors (poor diet, physical inactivity and obesity) for the development and progression of renal damage, and less information exists on non-traditional factors such as oxidative stress and mainly, the low antioxidant response that characterizes both DM and nephropathy. In addition, there is a great variation in the susceptibility to and progression of kidney disease between different populations that is not explained by the presence of traditional factors and that could be triggered by genetic variations and its interaction with other components related to the environment and lifestyle. Fortunately, there is sufficient scientific evidence that early detection and modification of negative lifestyle factors can not only delay or halt the progression of the renal function decline to ESRD but can also significantly reduce the incidence of cardiovascular disease leading to premature death in most of these patients. Therefore, it is suggested that this risk may be determined by the interaction of lifestyle factors with the presence of susceptibility alleles, which may vary from one population to another. It is now known that hyperglycemia causes a state of oxidative stress and inflammation that can be counteracted by diet supplementation with some natural antioxidants such as curcumin. It has been shown that this molecule has multiple pharmacological properties: antioxidant, anti-inflammatory, cardioprotective, renoprotective, among others. In clinical trials a positive effect of curcumin has been seen in the treatment of diabetes and its complications. This has generated a relative optimism in the search for new curcumin treatment targets where oxidative stress is of great relevance, as is the case with CKD. However, there are still doubts about its efficacy as an adjuvant in the prevention of CKD. Additionally, the role played by interindividual variability in genes involved in the mechanism of action of curcumin is still incipient, more studies in this knowledge area are necessary.
Detailed description
Aim: To evaluate the interaction between rs35652124 polymorphism and curcumin supplementation on the levels of NFE2L2 gene expression, antioxidant capacity and renal function in patients with early diabetic nephropathy (EDN).
Subjects and Methods. Parallel clinical trial with randomized and triple blind. From a database of diabetic patients newly diagnosed with CKD, those with EDN will be identified and located by telephone to complete a total of 275 subjects over 18 years of age. Subsequently, they will be cited in the office of Biomedical Unit 02, will verify that they meet the selection criteria, will be informed about the objectives of the study and invited to participate. Those who agree to participate will be given an informed consent letter, they will be asked to read it carefully and if they have any doubts, they will be clarified at the moment. Once they have signed the written consent they will be cited for the first blood sample collecting (5 mL) to be used for genomic DNA extraction and genotyping for the rs35652124 polymorphism. All patients entering the study will undergo a physical and dietary examination and will record the data on a clinical record card. They will be prescribed a meal plan according to ADA recommendations and K/DOQI guidelines two weeks prior (week <2) at the start of the clinical trial, which will be maintained throughout the follow-up. They will then be scheduled monthly for medical and nutritional assessment. At the visits of weeks 2, 0 (start of supplementation), 12, and 24, three peripheral blood tubes (5 mL each) will be drawn. The first, to extract total mRNA and expression analysis of the NFE2L2 gene, the second, to determine the levels of NRF2, SOD, GPx and HO1 and the third, to perform renal function tests and control of possible confounding variables (creatinine, glucose, glycosylated hemoglobin, lipid profile and uric acid). In addition, they will be asked to collect a sample of the first morning urine to quantify albuminuria/creatinuria on the same day that blood samples were taken. The time of the study since the first evaluation is 26 weeks and the total number of medical and nutrition visits will be six, one monthly. Genotyping will be performed by polymerase chain reaction (PCR) coupled to four pairs of oligonucleotide primers specific for the alleles of interest. The gene expression assay will be performed by real-time PCR, while the determination of the concentrations of NRF2, SOD, GPx and HO1 will be carried out by the ELISA method with kits designed for this purpose. The analysis of the data includes descriptive statistics expressed in averages and standard or median deviations according to the parametric or non-parametric distribution, the nominal variables will be presented as numbers or percentages and the comparison between these will be by Chi square or Fisher exact. Inferential statistics included U-Mann Whitney or Student t tests for independent and paired samples as appropriate to evaluate the NRF2, SOD, GPx and HO1 concentrations with the different interventions and the individuals in the control group. A covariance analysis will be performed taking into consideration the factor supplementation, genetic factor and the interaction of both with the concentrations of NRF2. A value of p<0.05 and 95% CI will be considered significant.
Resources and infrastructure. The CIBO and the Medical Research Unit in Renal Diseases have the human resources to coordinate and develop the present research. Also, they have the necessary infrastructure and equipment to carry out the procedures contemplated in this project. The project will be submitted to calls for funding to obtain the necessary resources for its development.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, care provider, investigator)
- Number of arms
- 2
- Model description
- The study starts from the classification of patients according to the genotype for the rs35652124 polymorphism (-653G>A) of the NFE2L2 gene. Two Experimental groups and two Control groups will be formed according to the following: Experimental group 1: Diabetic patients with early CKD homozygous for the -653G (G/G) allele of the NFE2L2 gene that will receive curcumin. Experimental group 2: Diabetic patients with early CKD carrying the allele -653A (G/A or A/A) of the NFE2L2 gene that will receive curcumin. Control group 1: Diabetic patients with early CKD homozygous for the -653G (G/G) allele of the NFE2L2 gene receiving placebo. Control group 2: Diabetic patients with early CKD carrying the allele -653A (G/A or A/A) of the NFE2L2 gene who will receive placebo.
| Arm | Type | Receives |
|---|---|---|
| Curcumin/NFE2L2 A>G | Experimental | Combination Product: Curcumin/NFE2L2 A>GPatients in Experimental group 1 and 2 will receive 800 mg/day of curcumin (for which a bioavailability of about 90% has been demonstrated and greater than other curcuminoids, administered in two doses of 400 mg each (the presentation will be in capsules containing 400 mg of THC). |
| Placebo/NFE2L2 A>G | Placebo comparator | Combination Product: Placebo/NFE2L2 A>GPatients in control group 1 and 2, the placebo intervention will consist of administering sucralose capsules (a substance lacking pharmacological action, with no active principle and a lower intake of glucose compared to sucrose). Patients will receive 300 mg/day of sucralose distributed in two doses of 150 mg each. |
Who may qualify
- Ages
- 18 to 90 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- With T2DM according to the American Diabetes Association
- With any time of T2DM evolution
- With CKD stage 1-3a according to the K/DIGO guidelines
Key exclusion criteria (3 listed)
- Incomplete evaluations
- That they have not been attached to the assigned intervention with an established frequency of <80%
- Decide to withdraw from the study
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Curcumin/NFE2L2 A>GAlso: Curcumin groupThe administration will be orally and the patient will be instructed to take two capsules per day for one week, one in the morning 15 minutes before breakfast and another at night 15 minutes before dinner, accompanied by a cup of 240 mL of pure water. It will be indicated to continue with their usual medical treatment. | Combination product | Curcumin/NFE2L2 A>G |
| Placebo/NFE2L2 A>GAlso: Placebo groupThe administration will be orally and the patient will be instructed to take two capsules for 24 weeks, one in the morning 15 minutes before breakfast and another in the evening 15 minutes before dinner, accompanied by a 240 mL cup of pure water. They will be advised to continue their usual medical treatment. | Combination product | Placebo/NFE2L2 A>G |
Primary outcome
Change from Baseline expression Gen NFE2L2 at 3 months
Time frame: Baseline at 3 months
mRNA and active protein NRF2
Change from Baseline expression Gen NFE2L2 at 6 months
Time frame: Baseline at 6 months
mRNA and active protein NRF2
Change from Antioxidant capacity at 3 months
Time frame: Baseline at 3 months
Superoxide dismutase, hemoxygenase 1, Glutathion peroxidase using the ELISA technique
Change from Antioxidant capacity at 6 months
Time frame: Baseline at 6 months
Superoxide dismutase, hemoxygenase 1, Glutathion peroxidase using the ELISA technique
Change from Renal Function at 3 months
Time frame: Baseline at 3 months
Glomerular Filtration Rate (Serum creatinine) and Albuminuria (Albumin/Creatinine Ratio)
Change from Renal Function at 6 months
Time frame: Baseline at 6 months
Glomerular Filtration Rate (Serum creatinine) and Albuminuria (Albumin/Creatinine Ratio)
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 30 May 2018.
- BackgroundUnited States Renal Data Sytem. 2016 USRDS annual data report: Epidemiology of kidney disease in the United States. National Institutes of Health, National Institute of Diabetes and Digestive and Kidney Diseases. Bethesda, MD, 2016.
- BackgroundGutiérrez JP, Rivera Dommarco J, Shamah Levy T, et al. Encuesta Nacional de Salud y Nutrición 2012. Resultados Nacionales. Cuernavaca, México: Salud Publica Mex; 2012.
- BackgroundHernández Ávila M, Gutiérrez JP, editores. Diabetes mellitus: la urgencia de reforzar la respuesta en políticas públicas para su prevención y control. Cuernavaca, México: Salud Publica Mex; 2012.
- BackgroundAsociación Latinoamericana de Diabetes (ALAD). Guías ALAD sobre el diagnóstico, control y tratamiento de la diabetes mellitus Tipo 2 con medicina basada en evidencia. 1a ed. Latinoamérica: ALAD; 2013.
- BackgroundHernández Ávila M, Rivera Dommarco J, Shamah Levy T. Encuesta Nacional de Salud y Nutrición 2016. Resultados Nacionales. Cuernavaca, México: Instituto Nacional de Salud Pública (MX), 2016.
- BackgroundCueto Manzano AM, Cortés Sanabria L, Martínez Ramírez HR, et al. Enfermedad Renal Crónica Temprana: Prevención, diagnóstico y tratamiento. México: Médica Panamericana; 2013. pp. 250.
- Background: PubMed 15606719Wolf G. New insights into the pathophysiology of diabetic nephropathy: from haemodynamics to molecular pathology. Eur J Clin Invest. 2004 Dec;34(12):785-96. doi: 10.1111/j.1365-2362.2004.01429.x.
- Background: PubMed 17167242Navarro JF, Milena FJ, Mora C, Leon C, Garcia J. Renal pro-inflammatory cytokine gene expression in diabetic nephropathy: effect of angiotensin-converting enzyme inhibition and pentoxifylline administration. Am J Nephrol. 2006;26(6):562-70. doi: 10.1159/000098004. Epub 2006 Dec 13.
- Background: PubMed 23716596Uruno A, Furusawa Y, Yagishita Y, Fukutomi T, Muramatsu H, Negishi T, Sugawara A, Kensler TW, Yamamoto M. The Keap1-Nrf2 system prevents onset of diabetes mellitus. Mol Cell Biol. 2013 Aug;33(15):2996-3010. doi: 10.1128/MCB.00225-13. Epub 2013 May 28.
- BackgroundGómez García EF, Martínez Ramírez HR, Cortés Sanabria L, et al. Cambios y mejoras en la calidad de la dieta en pacientes con enfermedad renal crónica temprana. En: Conferencia dentro del marco del XLVII Congreso Nacional de Nefrología; 2013 Sep 4-12; Guadalajara, Jalisco. México.
- Background: PubMed 15756217Balagopal P, George D, Patton N, Yarandi H, Roberts WL, Bayne E, Gidding S. Lifestyle-only intervention attenuates the inflammatory state associated with obesity: a randomized controlled study in adolescents. J Pediatr. 2005 Mar;146(3):342-8. doi: 10.1016/j.jpeds.2004.11.033.
- Background: PubMed 23325084Ruiz S, Pergola PE, Zager RA, Vaziri ND. Targeting the transcription factor Nrf2 to ameliorate oxidative stress and inflammation in chronic kidney disease. Kidney Int. 2013 Jun;83(6):1029-41. doi: 10.1038/ki.2012.439. Epub 2013 Jan 16.
- Individual participant dataSharing planned: Undecided
Related trials for Chronic Kidney Diseases
RecruitingObservational study
Immune System Related Kidney Disease
Kidney Disease, Nephrotic Syndrome
Recruiting
Diuretic Tuner Clinical Decision Support
Edema, Hypervolemia
Recruiting
Transcutaneous Auricular Vagus Nerve Stimulation (taVNS) in Chronic Kidney Disease (CKD)
Chronic Kidney Diseases
RecruitingObservational study
Rare Disease Patient Registry & Natural History Study - Coordination of Rare Diseases at Sanford
Rare Disorders, Undiagnosed Disorders
Recruiting
Maturation of Arteriovenous Fistula With Automated Sonography Assessments Trial
Diabetes, End Stage Renal Disease
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2/3 study testing Curcumin/NFE2L2 A>G in people with Chronic Kidney Diseases and Diabetes Mellitus, Type 2, run by Unidad de Investigacion Medica en Enfermedades Renales at 1 site in Mexico.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 30 May 2018. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Mexico. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this combined phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact LAURA CORTES-SANABRIA, PhD ((55)3339522038 ext. 32204, cortes_sanabria@yahoo.com.mx), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change from Baseline expression Gen NFE2L2 at 3 months (time frame: Baseline at 3 months). The study lists 6 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT03262363, which also lists 15 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 30 May 2018; AzTrials last refreshed its copy on 30 Oct 2026.