Aim of this study is evaluation of melatonin effect on blood glucose in patients with type 2 diabetes. The study is double-blind and randomized and 60 patients recruited in two groups. One group consume 6 mg melatonin and second group recieve placebo for three months. Before and after intervention blood glucose, A1C and lipids are measured. Patients with epilepsy, renal or liver failure and who use warfarin are excluded.
General information
Acronym
IRCT registration information
IRCT registration number:IRCT2016010520219N2
Registration date:2016-03-13, 1394/12/23
Registration timing:prospective
Last update:
Update count:0
Registration date
2016-03-13, 1394/12/23
Registrant information
Name
Mozhgan Afkhamizadeh
Name of organization / entity
Mashhad Universirty of Medical Sciences , Imam Reza Hospital
Country
Iran (Islamic Republic of)
Phone
+98 51 3859 8818
Email address
afkhamizadehm@mums.ac.ir
Recruitment status
Recruitment complete
Funding source
Mashhad university of medical sciences
Expected recruitment start date
2016-04-03, 1395/01/15
Expected recruitment end date
2016-09-05, 1395/06/15
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Effect of melatonin on serum glucose level in patiets with type 2 diabetes
Public title
Effect of melatonin on diabetes
Purpose
Treatment
Inclusion/Exclusion criteria
inclusion criteria : type 2 diabetes; FBS less than 250
exclusion criteria : renal failure; hepatic failure; epilepsy; pregnancy; breast feeding; warfarin consumption; psychotic disease
Age
From 25 years old to 65 years old
Gender
Both
Phase
N/A
Groups that have been masked
No information
Sample size
Target sample size:
60
Randomization (investigator's opinion)
Randomized
Randomization description
Blinding (investigator's opinion)
Double blinded
Blinding description
Placebo
Used
Assignment
Parallel
Other design features
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Mashhad University of Medical Sciences
Street address
research chancellor, Mashhad university of medical sciences, Daneshgah St.
City
Mashhad
Postal code
91388-13944
Approval date
2015-11-18, 1394/08/27
Ethics committee reference number
IR. MUMS. fm. REC. 1394.479
Health conditions studied
1
Description of health condition studied
type 2 diabetes
ICD-10 code
E11
ICD-10 code description
Non-insulin-dependent diabetes mellitus
Primary outcomes
1
Description
fasting blood glucose
Timepoint
before and after intervention
Method of measurement
laboratory measurement (mg/dl)
Secondary outcomes
1
Description
serum lipids
Timepoint
before and three months after intervention
Method of measurement
laboratory (mg/dl)
Intervention groups
1
Description
intervention: melatonin 6 mg
Category
Treatment - Drugs
2
Description
control : placebo
Category
Treatment - Drugs
Recruitment centers
1
Recruitment center
Name of recruitment center
Ghaem Hospital ,Mashhad Endocrine Research Center
Full name of responsible person
Mozhgan Afkhamizadeh
Street address
City
Mashhad
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Mashhad University of Medical Sciences
Full name of responsible person
Aliakbar Saber Moghadam
Street address
Research chancellor, MashhadUniversity of Medical Sciences, Daneshgah St.
City
Mashhad
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Mashhad University of Medical Sciences
Proportion provided by this source
100
Public or private sector
empty
Domestic or foreign origin
empty
Category of foreign source of funding
empty
Country of origin
Type of organization providing the funding
empty
Person responsible for general inquiries
Contact
Name of organization / entity
Mashad University of Medical Sciences
Full name of responsible person
Mozhgan Afkhamizadeh
Position
Assisitan professor
Other areas of specialty/work
Street address
Internal medicine department, Imam Reza Hospital
City
Mashhad
Postal code
Phone
+98 51 3859 8818
Fax
Email
afkhamizadehm@mums.ac.ir
Web page address
Person responsible for scientific inquiries
Contact
Name of organization / entity
Mashhad Endocrine and Metabolism Research Centre, Mashhad University of Medical Sciences
Full name of responsible person
Mozhgan Afkhamizadeh
Position
endocrinologist
Other areas of specialty/work
Street address
Internal medicine department, Imam Reza hospital
City
Mashhad
Postal code
Phone
+98 51 3859 8818
Fax
Email
afkhamizadehm@mums.ac.ir
Web page address
Person responsible for updating data
Contact
Name of organization / entity
Full name of responsible person
Mozhagn Afkhamizadeh
Position
Other areas of specialty/work
Street address
City
Postal code
Phone
00
Fax
Email
Web page address
Sharing plan
Deidentified Individual Participant Data Set (IPD)