Protocol summary
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Study aim
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Objective: The aim of this study is to determine the effects of melatonin supplementation on metabolic profiles and gene expression related to inflammation, insulin and lipid in diabetic hemodialysis patients.
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Design
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Study design: randomized double-blind placebo-controlled trial. Patients will be assigned into two groups to receive melatonin supplement (n=30) or placebo (n=30).
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Settings and conduct
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Among diabetic hemodialysis patients referred to Akhavan Clinic, 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. Supplements and placebos are similar in shape and size. Fasting blood samples will be taken at baseline and end of the intervention. intervention: 12 weeks.
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Participants/Inclusion and exclusion criteria
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Inclusion criteria: diabetic hemodialysis patients; aged 18 to 80 years. Exclusion criteria: Patients with infectious, inflammatory and malignant diseases, those taking melatonin supplements, antioxidant and/or anti-inflammatory supplements within 3 months prior to enrollment in the study, the night shift workers, subjects taking immunosuppressive and antibiotics medications, unwillingness to cooperate
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Intervention groups
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Intervention group: Melatonin supplements (Zahravi, Tabriz, Iran), 10 mg, two capsules (5 mg each) one hour before bedtime for 12 weeks orally. Control group: placebo (Zahravi, Tabriz, Iran), two capsules one hour before bedtime for 12 weeks orally.
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Main outcome variables
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Outcomes: markers of insulin metabolism (primary outcomes) and inflammatory factors, oxidative stress biomarkers and gene expression related to insulin, lipid and inflammation, and parameters of mental health (secondary 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:
IRCT20170513033941N31
Registration date:
2018-02-14, 1396/11/25
Registration timing:
registered_while_recruiting
Last update:
2019-10-17, 1398/07/25
Update count:
1
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Registration date
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2018-02-14, 1396/11/25
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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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2018-02-09, 1396/11/20
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Expected recruitment end date
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2018-02-24, 1396/12/05
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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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Clinical trial of the effect of melatonin supplementation compared with the placebo on metabolic status and gene expression related to inflammation, insulin and lipid in diabetic hemodialysis patients
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Public title
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Effect of melatonin supplementation in treatment of diabetic hemodialysis patients
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Purpose
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Treatment
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Inclusion/Exclusion criteria
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Inclusion criteria:
Inclusion criteria: diabetic hemodialysis patients
Individuals aged 18 to 80 years old
Exclusion criteria:
Exclusion criteria: Patients with infectious, inflammatory and malignant diseases
those taking melatonin supplements, antioxidant and/or anti-inflammatory supplements within 3 months prior to enrollment in the study
the night shift workers
subjects taking immunosuppressive and antibiotics medications
unwillingness to cooperate
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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 the onset of the study, after balanced blocked randomization, all participants will be allocated into two groups to take either melatonin or placebo.
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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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2018-02-07, 1396/11/18
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Ethics committee reference number
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IR.KAUMS.MEDNT.REC.1396.107
Health conditions studied
1
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Description of health condition studied
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Hemodialysis
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ICD-10 code
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N18
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ICD-10 code description
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Chronic kidney disease (CKD)
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 after 12 weeks of 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 12 weeks of intervention
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Method of measurement
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Calculation using HOMA formula
3
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Description
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Insulin sensitivity
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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 formula
Secondary outcomes
1
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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
2
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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
3
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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
4
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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
5
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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 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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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
7
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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
8
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Description
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HDL
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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
9
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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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PCR
10
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Description
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Expressed levels of TGF-beta 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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PCR
11
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Description
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Expressed levels of IL-8 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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PCR
12
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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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PCR
13
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Description
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Expressed 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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PCR
14
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Description
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Beck Depression Inventory
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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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Questionnaire
15
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Description
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Beck Anxiety Inventory
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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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Questionnaire
16
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Description
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Pittsburgh Sleep Quality Index
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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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Questionnaire
Intervention groups
1
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Description
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Intervention group: Melatonin supplements (Zahravi, Tabriz, Iran), 10 mg, two capsules (5 mg each) one hour before bedtime 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 (Zahravi, Tabriz, Iran), two capsules one hour before bedtime for 12 weeks orally.
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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