Evaluation of the effect of melatonin supplementation on Carotid Intima-Media Thickness, pulse-wave velocity and serum levels of hs-CRP in patients with diabetic nephropathy
Determining the effect of melatonin supplementation on Carotid intima-media thickness, pulse-wave velocity and serum levels of hs-CRP in patients with diabetic nephropathy
Design
Two arms; parallel groups; randomized trial with control; double-blind, phase 3, including 60 patients. randomization is achieved by using computer software.
Settings and conduct
This study will be done on 60 diabetic patients with proteinuria (based on inclusion criteria) in Kashan city. Patients will be recruited in Nephrology center of Shahid Beheshti hospital (associated with Kashan University of Medical Sciences) based on inclusion criteria. hs-CRP, CIMT and PWV will be measured before and after receiving the medication or placebo. radiologists and lab workers are kept blind.
Participants/Inclusion and exclusion criteria
Inclusion criteria: Approved diabetes; Proteinuria > 500 mg per day; GFR between 15-89 mLit/min; HbA1c < 7.2; Systolic blood pressure between 140-160 mmHg and Diastolic blood pressure between 90-100 mmHg. Exclusion Criteria: Systolic blood pressure > 160 mmHg or Diastolic blood pressure > 100 mmHg; Pregnant or Lactating; Smoker or alcohol abuser; Underlying diseases including cardiovascular diseases, cancer, autoimmune disorders and hypo or hyperthyroidism; Using fluvoxamine or antioxidant drugs; Urinary tract infection or other diseases that cause proteinuria; Night worker.
Intervention groups
Melatonin group which receives melatonin . control group which receives placebo .
Main outcome variables
Pulse wave velocity and Carotid intima-media thickness
General information
Reason for update
Acronym
IRCT registration information
IRCT registration number:IRCT20200527047584N2
Registration date:2020-07-21, 1399/04/31
Registration timing:retrospective
Last update:2020-07-21, 1399/04/31
Update count:0
Registration date
2020-07-21, 1399/04/31
Registrant information
Name
Hamidreza Talari
Name of organization / entity
Country
Iran (Islamic Republic of)
Phone
+98 31 5554 0026
Email address
talari_hr@kaums.ac.ir
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2020-04-20, 1399/02/01
Expected recruitment end date
2020-06-21, 1399/04/01
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Evaluation of the effect of melatonin supplementation on Carotid Intima-Media Thickness, pulse-wave velocity and serum levels of hs-CRP in patients with diabetic nephropathy
Public title
Evaluation of the effect of melatonin supplementation on vascular diseases in patients with diabetic nephropathy
Purpose
Prevention
Inclusion/Exclusion criteria
Inclusion criteria:
Approved diabetes
Proteinuria > 500 miligram per day
GFR between 15-89 mLit/min
HbA1c < 7.2
Systolic blood pressure between 140-160 mmHg and Diastolic blood pressure between 90-100 mmHg
Exclusion criteria:
Pregnant or Lactating
Smoker or alcohol abuser
Underlying diseases including cardiovascular diseases, cancer, autoimmune disorders and hypo or hyperthyroidism
Using fluvoxamine or antioxidant drugs
Urinary tract infection or other diseases that cause proteinuria
Night worker
Age
From 40 years old to 85 years old
Gender
Both
Phase
3
Groups that have been masked
Participant
Care provider
Investigator
Outcome assessor
Sample size
Target sample size:
60
Randomization (investigator's opinion)
Randomized
Randomization description
After specifying the sample size, blocks of size 4 consisting of A and B letters are formed (6 blocks). Then, each of the blocks is numbered 1 to 6 and based on the selected numbers from random numbers table, we form a sequence of blocks, in which the letters A and B are located, and then randomly one of the letters are considered as the drug group and the other letter as the control group. This method is referred to as "Permuted Blocked Randomization".
Blinding (investigator's opinion)
Double blinded
Blinding description
Patients, radiologists and technicians who calculate pulse wave velocity are unaware of patients' groups.
Placebo
Used
Assignment
Parallel
Other design features
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Ethics committee of Kashan University of Medical Sciences
Street address
Kashan University of Medical Sciences, Ghotb Ravandi St
City
Kashan
Province
Isfehan
Postal code
8115187159
Approval date
2020-02-17, 1398/11/28
Ethics committee reference number
IR.KAUMS.MEDNT.REC.1398.133
Health conditions studied
1
Description of health condition studied
Diabetes
ICD-10 code
E11
ICD-10 code description
Type 2 diabetes mellitus
Primary outcomes
1
Description
Carotid-femoral pulse wave velocity
Timepoint
Before intervention and 24 weeks after intervention
Method of measurement
Color doppler ultrasound
2
Description
Carotid Intima-media thickness
Timepoint
Before intervention and 24 weeks after intervention
Method of measurement
Color doppler ultrasound
Secondary outcomes
1
Description
hs-CRP level
Timepoint
before and 24 weeks after intervention
Method of measurement
Blood test
Intervention groups
1
Description
Intervention group: melatonin 5 mg (from NUTRALab), 2 capsules daily (half hour before sleep) for 24 weeks
Category
Treatment - Drugs
2
Description
Control group: placebo, 2 capsules daily (half hour before sleep) for 24 weeks
Category
Treatment - Drugs
Recruitment centers
1
Recruitment center
Name of recruitment center
Kashan Shahid Beheshti Hospital
Full name of responsible person
Mojtaba Ghasemi Adl
Street address
Shahid Beheshti Hospital, Ghotbe Ravandi Street
City
Kashan
Province
Isfehan
Postal code
8115187159
Phone
+98 31 5562 1552
Email
beheshtihospital@kaums.ac.ir
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Kashan University of Medical Sciences
Full name of responsible person
Hamidreza Banafshe
Street address
Kashan University of Medical sciences, Ghotbe Ravandi Street
City
Kashan
Province
Isfehan
Postal code
8115187159
Phone
+98 31 5557 8010
Email
research@kaums.ac.ir
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
Person responsible for general inquiries
Contact
Name of organization / entity
Kashan University of Medical Sciences
Full name of responsible person
Hamidreza Talari
Position
Professor
Latest degree
Specialist
Other areas of specialty/work
Radiology
Street address
Postal Code 81151/87159, Shahid Beheshti Hospital, Pezeshk Ave, Ravand Street
City
Kashan
Province
Isfehan
Postal code
8115187159
Phone
+98 31 5554 0026
Fax
Email
talari_hr@kaums.ac.ir
Person responsible for scientific inquiries
Contact
Name of organization / entity
Kashan University of Medical Sciences
Full name of responsible person
Hamidreza Talari
Position
Professor
Latest degree
Specialist
Other areas of specialty/work
Radiology
Street address
Postal Code 81151/87159, Shahid Beheshti Hospital, Pezeshk Ave, Ravand Street
City
Kashan
Province
Isfehan
Postal code
8115187159
Phone
+98 31 5554 0026
Fax
Email
talari_hr@kaums.ac.ir
Person responsible for updating data
Contact
Name of organization / entity
Kashan University of Medical Sciences
Full name of responsible person
Hamidreza Talari
Position
Professor
Latest degree
Specialist
Other areas of specialty/work
Radiology
Street address
Postal Code 81151/87159, Shahid Beheshti Hospital, Pezeshk Ave, Ravand Street
City
Kashan
Province
Isfehan
Postal code
8115187159
Phone
+98 31 5554 0026
Fax
Email
talari_hr@kaums.ac.ir
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
Not applicable
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
Not applicable
Data Dictionary
Undecided - It is not yet known if there will be a plan to make this available