Comparison of the effect of oral melatonin administration with placebo on biochemical parameters associated with diabetes in diabetes mellitus Type 2 patients
The aim of present study is to determine whether adding melatonin tablet as adjuvant to diabetes treatment regimen in patients with type 2 diabetes will improve the glucose control with assessment of biochemical parameters associated with diabetes.
Design
Design of the study is a triple-blind, placebo-controlled, randomized control single center clinical trial.
Patients with age more than 18 years old with type 2 diabetes have been diagnosed based on ADA (American Diabetes Association) 2017 guideline will be enrolled the study. Patients whom are not desired to enroll the study will be excluded.In this research, 80 eligible patients with type 2 diabetes compatible with inclusion criteria were chosen. patients were randomly divided into two control and intervention groups by Microsoft Excel software. and a code was allocated to each one of them.
Settings and conduct
This study is conducted as placebo controlled triple blinded randomized clinical trial in Shahid Beheshti research institute of endocrine science. participants, researcher & statistical data analyzer all has been blinded.
Participants/Inclusion and exclusion criteria
Inclusion criteria:
Type 2 diabetes based on ADA 2017 guideline
Age more than 18 years old
Exclusion criteria:
History of confirmed hypersensitivity reaction to melatonin or any parts of formulation
eGFR less than 30 ml/min/1.73m2
Liver failure (child pugh B, C)
Pregnancy & lactation
Uncontrolled seizure & untreated major depressive disorder
Concurrent use of fluvoxamine & nifedipine
Intervention groups
Intervention group (melatonin supplement):
type 2 dietetic patients compatible with inclusion/exclusion criteria on any diabetes treatment regimens administrated with 6 mg oral melatonin supplement daily for 2 mouths.
Control group (melatonin placebo):
type 2 dietetic patients compatible with inclusion/exclusion criteria on any diabetes treatment regimens administrated with 6 mg oral melatonin placebo daily for 2 mouths.
Main outcome variables
Change in blood level of FBS, HgbA1c, HOMA-IR, HOMA-beta, lipid profile, hs-CRP and melatonin 2 months after initiation of melatonin
General information
Reason for update
Acronym
IRCT registration information
IRCT registration number:IRCT20121021011192N4
Registration date:2018-01-06, 1396/10/16
Registration timing:registered_while_recruiting
Last update:2018-01-06, 1396/10/16
Update count:0
Registration date
2018-01-06, 1396/10/16
Registrant information
Name
Mohammad Abbasinazari
Name of organization / entity
Shahid Beheshti University of Medical Sciences
Country
Iran (Islamic Republic of)
Phone
+98 21 8887 3704
Email address
m_abbasi@sbmu.ac.ir
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2017-12-22, 1396/10/01
Expected recruitment end date
2018-09-22, 1397/06/31
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Comparison of the effect of oral melatonin administration with placebo on biochemical parameters associated with diabetes in diabetes mellitus Type 2 patients
Public title
Melatonin in type 2 diabetes
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria:
Type 2 diabetes based on ADA (American Diabetes Association) 2017 guideline
Age more than 18 years old
Exclusion criteria:
History of confirmed hypersensitivity reaction to melatonin or any parts of formulation
eGFR less than 30 ml/min/1.73m2
Liver failure (child pugh B, C)
Pregnancy & lactation
Uncontrolled seizure & untreated major depressive disorder
Concurrent use of fluvoxamine & nifedipine
Age
From 18 years old
Gender
Both
Phase
3
Groups that have been masked
Participant
Care provider
Investigator
Outcome assessor
Data analyser
Sample size
Target sample size:
88
Randomization (investigator's opinion)
Randomized
Randomization description
ُُSimple individual randomization with Microsoft Excel software
Blinding (investigator's opinion)
Triple blinded
Blinding description
Participants, principle investigator, healthcare providers (Physicians, nurses) who care for participants during the trial, data collectors and outcome assessors all are blinded by providing placebo melatonin in same size, shape color, odor and package with real melatonin tablet which organized just by one responsible co-researcher has no involvement in running study.
Placebo
Used
Assignment
Parallel
Other design features
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Ethics committee of Research Institute for Endocrine Sciences Shahid Beheshti University of Medical