Protocol summary
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Study aim
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The aim of this study is to determine the effects of Nano-curcumin supplementation on metabolic status in patients with diabetic hemodialysis.
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Design
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Parallel double-blind (both patients and researchers) randomized controlled clinical trial. Random assignment will be done by the use of computer-generated random numbers.
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Settings and conduct
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Akhavan Clinic, Kashan, Iran
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Participants/Inclusion and exclusion criteria
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Inclusion criteria:
Diabetic hemodialysis patients; aged 18 to 80
Exclusion criteria:
Patients suffering from infectious, inflammatory and malignant diseases.
Patients taking curcumin supplements, antioxidant and/or anti-inflammatory supplements within 3 months before participation in the study.
subjects receiving immunosuppressive and antibiotics medications.
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Intervention groups
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Patients will be assigned to receive Nano-curcumin supplements (n=30) and placebo (n=30).
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Main outcome variables
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Fasting blood samples will be taken at baseline and after 12-week intervention. Insulin and insulin resistance as primary outcomes and inflammatory factors, biomarkers of oxidative stress, and serum lipoproteins as secondary outcomes will be measured at baseline and end-of-trial.
General information
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Reason for update
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Acronym
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IRCT registration information
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IRCT registration number:
IRCT20150606022562N6
Registration date:
2019-02-11, 1397/11/22
Registration timing:
retrospective
Last update:
2019-09-25, 1398/07/03
Update count:
1
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Registration date
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2019-02-11, 1397/11/22
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Registrant information
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Recruitment status
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Recruitment complete
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Funding source
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Expected recruitment start date
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2018-11-06, 1397/08/15
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Expected recruitment end date
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2018-11-26, 1397/09/05
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Actual recruitment start date
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empty
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Actual recruitment end date
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empty
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Trial completion date
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empty
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Scientific title
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The effects of Nano-curcumin on metabolic status in patients with diabetes on hemodialysis
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Public title
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The effect of Nano-curcumin in patients with diabetic hemodialysis
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Purpose
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Treatment
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Inclusion/Exclusion criteria
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Inclusion criteria:
Diabetic hemodialysis patients
Aged 18to 80 years
Exclusion criteria:
Patients suffering from infectious, inflammatory and malignant diseases.
Patients taking curcumin supplements, antioxidant and/or anti-inflammatory supplements within 3 months before participation in the study.
subjects receiving immunosuppressive and antibiotics medications.
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Age
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From 18 years old to 80 years old
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Gender
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Both
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Phase
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3
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Groups that have been masked
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- Participant
- Investigator
- Outcome assessor
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Sample size
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Target sample size:
60
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Randomization (investigator's opinion)
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Randomized
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Randomization description
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At study baseline, after balanced blocked randomisation, particpants will be allocated into two groups to take either Nano-curcumin supplements (n = 30) or placebos (n = 30). Randomization will be done by the use of computer-generated random numbers.
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Blinding (investigator's opinion)
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Double blinded
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Blinding description
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Randomization and allocation will be concealed from the researchers and participants until the final analyses are completed. Another person who is not involved in the trial and not aware of random sequences, will be assigned the participants to the numbered bottles of capsules.
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Placebo
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Used
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Assignment
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Parallel
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Other design features
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Ethics committees
1
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Ethics committee
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Approval date
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2018-11-05, 1397/08/14
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Ethics committee reference number
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IR.KAUMS.MEDNT.REC.1397.065
Health conditions studied
1
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Description of health condition studied
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Chronic kidney disease
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ICD-10 code
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N18.5
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ICD-10 code description
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Chronic kidney disease, stage 5
Primary outcomes
1
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Description
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Insulin
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Timepoint
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At the beginning of the study and 12 weeks after intervention
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Method of measurement
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Elisa kit
2
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Description
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Insulin resistance
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Timepoint
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At the beginning of the study and after 24 weeks of intervention
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Method of measurement
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Calculation using HOMA formula
Secondary outcomes
1
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Description
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Triglycerides
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Timepoint
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At the beginning of the study and after 12 weeks of intervention
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Method of measurement
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Enzymatic kit
2
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Description
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Total cholesterol
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Timepoint
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At the beginning of the study and after 12 weeks of intervention
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Method of measurement
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Enzymatic kit
3
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Description
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High-density lipoprotein-cholesterol (HDL-Cholesterol)
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Timepoint
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At the beginning of the study and after 12 weeks of intervention
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Method of measurement
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Enzymatic kit
4
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Description
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High sensitive-C-reactive protein (hs-CRP)
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Timepoint
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At the beginning of the study and after 12 weeks of intervention
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Method of measurement
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Elisa kit
5
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Description
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Total Nitric Oxide
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Timepoint
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At the beginning of the study and after 12 weeks of intervention
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Method of measurement
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Spectrophotometry
6
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Description
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Expression levels of PPAR-γ gene
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Timepoint
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At the beginning of the study and after 12 weeks of intervention
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Method of measurement
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Real-Time PCR
7
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Description
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Expression levels of LDLR gene
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Timepoint
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At the beginning of the study and after 12 weeks of intervention
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Method of measurement
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Real-Time PCR Method
8
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Description
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Gluthatione
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Timepoint
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At the beginning of the study and 12 weeks after intervention
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Method of measurement
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Spectrophotometry
9
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Description
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Total antioxidant capacity
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Timepoint
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At the beginning of the study and 12 weeks after intervention
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Method of measurement
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Spectrophotometry
10
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Description
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Malondialdehyde
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Timepoint
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At the beginning of the study and 12 weeks after intervention
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Method of measurement
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Spectrophotometry
11
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Description
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Expression levels of TGF-β gene
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Timepoint
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At the beginning of the study and 12 weeks after intervention
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Method of measurement
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Real-Time PCR Method
12
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Description
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Fasting blood sugar
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Timepoint
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At the beginning of the study and after 12 weeks of intervention
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Method of measurement
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Enzymatic kit
13
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Description
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VLDL
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Timepoint
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At the beginning of the study and after 12 weeks of intervention
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Method of measurement
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Enzymatic kit
14
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Description
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LDL
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Timepoint
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At the beginning of the study and after 12 weeks of intervention
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Method of measurement
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Enzymatic kit
15
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Description
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BUN
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Timepoint
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At the beginning of the study and after 12 weeks of intervention
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Method of measurement
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Enzymatic kit
16
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Description
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Creatinine
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Timepoint
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At the beginning of the study and after 12 weeks of intervention
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Method of measurement
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Enzymatic kit
17
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Description
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AGEs
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Timepoint
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At the beginning of the study and after 12 weeks of intervention
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Method of measurement
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Spectrophotometry
18
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Description
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Systolic blood pressure (SBP)
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Timepoint
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At the beginning of the study and after 12 weeks of intervention
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Method of measurement
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Sphygmomanometer
19
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Description
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Diastolic blood pressure (DBP)
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Timepoint
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At the beginning of the study and after 12 weeks of intervention
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Method of measurement
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Sphygmomanometer
Intervention groups
1
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Description
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Intervention group: receiving one 80 mg Nano-curcumin capsule per day for 12 weeks
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Category
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Treatment - Drugs
2
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Description
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Control group: Placebo oral capsule, daily, for 12 weeks.
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Category
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Placebo
1
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Sponsor
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Grant name
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Grant code / Reference number
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Is the source of funding the same sponsor organization/entity?
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Yes
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Title of funding source
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Kashan University of Medical Sciences
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Proportion provided by this source
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100
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Public or private sector
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Public
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Domestic or foreign origin
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Domestic
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Category of foreign source of funding
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empty
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Country of origin
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Type of organization providing the funding
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Academic
Sharing plan
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Deidentified Individual Participant Data Set (IPD)
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Undecided - It is not yet known if there will be a plan to make this available
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Study Protocol
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Undecided - It is not yet known if there will be a plan to make this available
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Statistical Analysis Plan
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Undecided - It is not yet known if there will be a plan to make this available
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Informed Consent Form
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Undecided - It is not yet known if there will be a plan to make this available
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Clinical Study Report
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Undecided - It is not yet known if there will be a plan to make this available
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Analytic Code
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Undecided - It is not yet known if there will be a plan to make this available
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Data Dictionary
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Undecided - It is not yet known if there will be a plan to make this available