Protocol summary
-
Study aim
-
Objective: The aim of this study is to determine the effects of melatonin supplementation on metabolic profiles in type 2 diabetes patients with coronary heart disease (CHD).
-
Design
-
Study design: Randomized double-blind placebo-controlled trial. Patients will be assigned into two groups to receive melatonin supplements (n=30) or placebo (n=30).
-
Settings and conduct
-
Among diabetic patients with CHD referred to Naghavi Cardiology Clinic 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.
-
Participants/Inclusion and exclusion criteria
-
Inclusion criteria: Individuals aged 50-85 years diagnosed with type 2 diabetes patients with coronary heart disease will be included in this study. Exclusion criteria: Exclusion criteria: Consuming melatonin supplements within the last 3 months, having an acute myocardial infarction and cardiac surgery within the past 3 months, and the night shift workers.
-
Intervention groups
-
Intervention group: two melatonin capsules (NUTRALab, Canada, 10 mg, 5 mg each capsule, daily, for 12 weeks orally. Control group: two Placebo capsules (Barij Essence, Kashan, Iran), daily, for 12 weeks orally.
-
Main outcome variables
-
Markers of oxidative stress (primary outcomes) and lipid profiles, biomarkers of inflammation and insulin metabolism (secondary outcome)
General information
-
Reason for update
-
The updating process was done after publishing the paper to correct the registration information.
-
Acronym
-
-
IRCT registration information
-
IRCT registration number:
IRCT2017051333941N1
Registration date:
2017-06-06, 1396/03/16
Registration timing:
retrospective
Last update:
2019-11-10, 1398/08/19
Update count:
2
-
Registration date
-
2017-06-06, 1396/03/16
-
Registrant information
-
-
Recruitment status
-
Recruitment complete
-
Funding source
-
Vice chancellor for research, Kashan University of Medical Sciences
-
Expected recruitment start date
-
2017-05-18, 1396/02/28
-
Expected recruitment end date
-
2017-05-31, 1396/03/10
-
Actual recruitment start date
-
empty
-
Actual recruitment end date
-
empty
-
Trial completion date
-
empty
-
Scientific title
-
Clinical trial of the effect of melatonin supplementation compared with the placebo on metabolic profiles in patients with coronary heart disease and type 2 diabetes mellitus
-
Public title
-
Effect of supplementation in treatment of Coronary Heart Disease
-
Purpose
-
Treatment
-
Inclusion/Exclusion criteria
-
Inclusion criteria:
Inclusion Criteria: Subjects aged 50-85 years; diagnosed with type 2 diabetes, CHD and overweight.
Exclusion criteria:
Exclusion criteria: Consuming melatonin supplements within the last 3 months
Having an acute myocardial infarction and cardiac surgery within the past 3 months
The night shift workers
-
Age
-
From 50 years old to 85 years old
-
Gender
-
Both
-
Phase
-
2
-
Groups that have been masked
-
- Participant
- Investigator
- Outcome assessor
-
Sample size
-
Target sample size:
60
-
Randomization (investigator's opinion)
-
Randomized
-
Randomization description
-
To decrease potential confounding effects, all participants will have stratified randomization according to BMI and age. Then, participants in each block will be randomly allocated into two treatment groups to take either supplements or placebo. Randomization will be done by the use of computer software.
-
Blinding (investigator's opinion)
-
Double blinded
-
Blinding description
-
Participants, investigators or the assessors of the outcomes are unaware of the study groups.
-
Placebo
-
Used
-
Assignment
-
Parallel
-
Other design features
-
Ethics committees
1
-
Ethics committee
-
-
Approval date
-
2017-05-17, 1396/02/27
-
Ethics committee reference number
-
IR.Kaums.REC.1396.26
Health conditions studied
1
-
Description of health condition studied
-
Coronary Heart Disease
-
ICD-10 code
-
I25.9
-
ICD-10 code description
-
Chronic ischaemic heart disease, unspecified
Primary outcomes
1
-
Description
-
Malondialdehyde
-
Timepoint
-
At the beginning of the study and after 12 weeks of intervention
-
Method of measurement
-
Spectrophotometry
2
-
Description
-
Glutathione
-
Timepoint
-
At the beginning of the study and after 12 weeks of intervention
-
Method of measurement
-
Spectrophotometry
3
-
Description
-
Total antioxidant capacity
-
Timepoint
-
At the beginning of the study and after 12 weeks of intervention
-
Method of measurement
-
Spectrophotometry
4
-
Description
-
Protein carbonyl
-
Timepoint
-
At the beginning of the study and after 12 weeks of intervention
-
Method of measurement
-
Spectrophotometry
Secondary outcomes
1
-
Description
-
Triglycerides
-
Timepoint
-
At the beginning of the study and after 12 weeks of intervention
-
Method of measurement
-
Enzymatic kit
2
-
Description
-
Total cholesterol
-
Timepoint
-
At the beginning of the study and after 12 weeks of intervention
-
Method of measurement
-
Enzymatic kit
3
-
Description
-
HDL
-
Timepoint
-
At the beginning of the study and after 12 weeks of intervention
-
Method of measurement
-
Enzymatic kit
4
-
Description
-
Insulin
-
Timepoint
-
At the beginning of the study and after 12 weeks of intervention
-
Method of measurement
-
ELISA kit
5
-
Description
-
Nitric oxide
-
Timepoint
-
At the beginning of the study and after 12 weeks of intervention
-
Method of measurement
-
Spectrophotometry
6
-
Description
-
Insulin resistance
-
Timepoint
-
At the beginning of the study and after 12 weeks of intervention
-
Method of measurement
-
Calculation using HOMA formula
7
-
Description
-
Hs-CRP
-
Timepoint
-
At the beginning of the study and after 12 weeks of intervention
-
Method of measurement
-
ELISA kit
8
-
Description
-
Beck Depression Inventory
-
Timepoint
-
At the beginning of the study and after 12 weeks of intervention
-
Method of measurement
-
Questionnaire
9
-
Description
-
Systolic blood pressure
-
Timepoint
-
At the beginning of the study and after 12 weeks of intervention
-
Method of measurement
-
Manometer
10
-
Description
-
Diastolic blood pressure
-
Timepoint
-
At the beginning of the study and after 12 weeks of intervention
-
Method of measurement
-
Manometer
11
-
Description
-
Beck Anxiety Inventory
-
Timepoint
-
At the beginning of the study and after 12 weeks of intervention
-
Method of measurement
-
Questionnaire
Intervention groups
1
-
Description
-
Intervention group: Melatonin supplements (NUTRALab, Scarborough, Canada), 5 mg, two capsules one hour before bedtime for 12 weeks orally.
-
Category
-
Treatment - Drugs
2
-
Description
-
Control group: Placebo capsule (Barij Essence, Kashan, Iran), two capsules one hour before bedtime for 12 weeks orally.
-
Category
-
Treatment - Drugs
1
-
Sponsor
-
-
Grant name
-
-
Grant code / Reference number
-
-
Is the source of funding the same sponsor organization/entity?
-
Yes
-
Title of funding source
-
Kashan University of Medical Sciences
-
Proportion provided by this source
-
100
-
Public or private sector
-
Public
-
Domestic or foreign origin
-
Domestic
-
Category of foreign source of funding
-
empty
-
Country of origin
-
-
Type of organization providing the funding
-
Academic
Sharing plan
-
Deidentified Individual Participant Data Set (IPD)
-
Undecided - It is not yet known if there will be a plan to make this available
-
Study Protocol
-
Undecided - It is not yet known if there will be a plan to make this available
-
Statistical Analysis Plan
-
Undecided - It is not yet known if there will be a plan to make this available
-
Informed Consent Form
-
Undecided - It is not yet known if there will be a plan to make this available
-
Clinical Study Report
-
Undecided - It is not yet known if there will be a plan to make this available
-
Analytic Code
-
Undecided - It is not yet known if there will be a plan to make this available
-
Data Dictionary
-
Undecided - It is not yet known if there will be a plan to make this available