Protocol summary
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Study aim
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Objective: The aim of this study is to determine the effects of probiotics supplementation on lipid profile, markers of insulin metabolism, biomarkers of inflammation and oxidative stress factors in patients with diabetes nephropathy.
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Design
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Study design: Parallel double-blind (both patients and researchers) clinical trial. Randomization will be done by the use of computer-generated random numbers. Patients will be assigned into two groups to receive probiotic (n=30) or placebo (n=30). Probiotic and placebos capsules are similar in shape and size.
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Settings and conduct
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Among patients with diabetic nephropathy referred to Shahid Beheshti Hospital affiliated to Kashan University of Medical Sciences, 60 patients will be selected according to inclusion and exclusion criteria. Participants, investigators or the assessors of the outcomes are unaware of the study groups.
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Participants/Inclusion and exclusion criteria
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Inclusion criteria: Patients with diabetic nephropathy and aged 45 to 85 years will be included in this study.Exclusion criteria:History of active infection within 3 months, intake of probiotic and/or synbiotic supplements within 3 months, history of hospital admission within 3 months, malignancy and/or liver cirrhosis.
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Intervention groups
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Intervention group: Probiotic supplements containing four strains of Lactobacillus acidophilus (2×109 CFU/g),Lactobacillus fermentum (2×109 CFU/g),Bifidobacterium bifidum (2×109 CFU/g),Lactobacillus reuteri (2×109 CFU/g), daily, for 12 weeks orally.
Control group: Placebo, daily, for 12 weeks orally.
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Main outcome variables
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Outcomes: Insulin metabolism parameters (primary outcomes) and lipid profiles,biomarkers of inflammation and oxidative stress factors (secondry outcomes) will be quantified at study 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:
IRCT2017061134458N1
Registration date:
2017-06-21, 1396/03/31
Registration timing:
retrospective
Last update:
2019-09-23, 1398/07/01
Update count:
1
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Registration date
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2017-06-21, 1396/03/31
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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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Vice chancellor for research, Kashan University of Medical Sciences
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Expected recruitment start date
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2017-05-15, 1396/02/25
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Expected recruitment end date
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2017-06-15, 1396/03/25
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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 effect of probiotic supplementation on lipid profile, markers of insulin metabolism, biomarkers of inflammation and oxidative stress factors in patients with diabetes nephropathy
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Public title
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Effect of supplementation in treatment of patients with diabetic nephropathy
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Purpose
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Treatment
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Inclusion/Exclusion criteria
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Inclusion criteria:
Patients with diabetic nephropathy aged 45 to 85 years
Exclusion criteria:
History of active infection within 3 months
Intake of probioticand/or synbiotic supplements within 3 months
History of hospitaladmission within 3 months
Malignancy and/or liver cirrhosis
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Age
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From 45 years old to 85 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 and after stratification for pre-intervention BMI and age, subjects will be randomly divided into two groups to receive supplement or placebo. 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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Participants, investigators or the assessors of the outcomes are unaware of the study groups.
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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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2017-04-30, 1396/02/10
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Ethics committee reference number
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IR.Kaums.REC.1396.43
Health conditions studied
1
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Description of health condition studied
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Diabetic nephropathy
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ICD-10 code
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N08.3
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ICD-10 code description
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Glomerular disorders in diabetes mellitus (E10-E14 with common fourth character .2+)
Primary outcomes
1
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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 12 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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Triglyceride
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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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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
3
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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
4
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Description
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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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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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Total antioxidant
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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
7
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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 after 12 weeks of intervention
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Method of measurement
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Spectrophotometry
8
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Description
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Glutathione
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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
9
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Description
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HbA1c
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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
10
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Description
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Serum 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
11
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Description
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Blood Urea Nitrogen
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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
12
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Description
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urine protein
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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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Expressed 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
14
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Description
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Expressed levels of LDL receptor 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
15
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Description
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Expressed levels of interleukin-1gene
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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
16
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Description
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Expressed levels of TNF-a 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
17
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Description
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Expressed levels of TGF-B 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
18
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Description
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advanced glycosylation end-products
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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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Fluorometric method
19
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Description
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Serum insulin
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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
Intervention groups
1
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Description
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Intervention group: Probiotic supplements containing four strains of Lactobacillus acidophilus (2×109 CFU/g),Lactobacillus fermentum (2×109 CFU/g),Bifidobacterium bifidum (2×109 CFU/g),Lactobacillus reuteri (2×109 CFU/g), daily, for 12 weeks orally.
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Category
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Treatment - Drugs
2
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Description
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Control group: Placebo, daily, for 12 weeks orally.
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Category
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Treatment - Drugs
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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Vice chancellor for research, 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