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The effects of melatonin on glucose and lipids profile in type II diabetic patients

Protocol summary

Summary
The aim of this double blind placebo controlled clinical trial is to investigate the effects of melatonin on glucose and lipids profile in type II diabetic patients. This study will be conducted as a before and after design and 76 patients who have inclusion criteria (diabetes mellitus type II, serum Cr<2mg/dl, HbA1c<8.5%) will receive placebo 2 tab/day for 12 weeks and then melatonin 6mg/day for another 12 weeks. Exclusion criteria will be melatonin consumption, pregnancy or breast feeding, current or history of epilepsy, smoking, drug addiction, alcohol or amphetamine abuse, warfarin or nifidipin medication, shifting job, history of coagulopathy or bleeding, change in diabetic or anti lipid treatment protocol, starting treatment by beta-blockers or diuretics. FBS and lipid profile will be measured in first evaluation and weeks 12 and 24.

General information

Acronym
IRCT registration information
IRCT registration number: IRCT2012062610115N1
Registration date: 2012-07-06, 1391/04/16
Registration timing: retrospective

Last update:
Update count: 0
Registration date
2012-07-06, 1391/04/16
Registrant information
Name
Gila Heshmati
Name of organization / entity
Arak university of medical sciences
Country
Iran (Islamic Republic of)
Phone
+98 86 1223 5605
Email address
dr.heshmati@arakmm.ac.ir
Recruitment status
Recruitment complete
Funding source
Vice Chancellor for Research, Arak University of Medical Sciences
Expected recruitment start date
2012-01-21, 1390/11/01
Expected recruitment end date
2012-05-20, 1391/02/31
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
The effects of melatonin on glucose and lipids profile in type II diabetic patients
Public title
The effects of melatonin on glucose and lipids profile in type II diabetic patients
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria: diabetes mellitus type II; serum Cr <2 mg/dl; HbA1c <8.5%. Exclusion criteria: melatonin consumption; pregnancy or breast feeding; current or history of epilepsy; smoking; drug addiction; alcohol or amphetamine abuse; warfarin or nifidipin medication; shifting job; history of coagulopathy or bleeding; change in diabetic or anti lipid treatment protocol; starting treatment by beta-blockers or diuretics.
Age
No age limit
Gender
Both
Phase
2-3
Groups that have been masked
No information
Sample size
Target sample size: 76
Randomization (investigator's opinion)
N/A
Randomization description
Blinding (investigator's opinion)
Double blinded
Blinding description
Placebo
Used
Assignment
Single
Other design features

Secondary Ids

empty

Ethics committees

1

Ethics committee
Name of ethics committee
Arak university of medical sciences
Street address
Arak university of medical sciences, Sardasht
City
Arak
Postal code
Approval date
2011-12-25, 1390/10/04
Ethics committee reference number
90-118-5

Health conditions studied

1

Description of health condition studied
diabetes mellitus type2
ICD-10 code
E11
ICD-10 code description
Non-insulin-dependent diabetes mellitus

Primary outcomes

1

Description
Fasting Blood Suger
Timepoint
weeks 0,12,24
Method of measurement
laboratory

2

Description
lipid profile
Timepoint
weeks 0,12,24
Method of measurement
laboratory

3

Description
HbA1c (%)
Timepoint
weeks 0,12,24
Method of measurement
laboratory

Secondary outcomes

empty

Intervention groups

1

Description
intervention: tab melatonin 3mg, 2 tab /day for 12 weeks
Category
Treatment - Drugs

2

Description
control: placebo, 2 tab/day for 12 weeks
Category
Placebo

Recruitment centers

1

Recruitment center
Name of recruitment center
Amir Almomenin hospital
Full name of responsible person
Street address
City
Arak

Sponsors / Funding sources

1

Sponsor
Name of organization / entity
Arak university of medical sciences
Full name of responsible person
Dr. Saeed Changizi Ashtyani
Street address
Arak university of medical sciences, Sardasht
City
Arak
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Arak 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
Arak university of medical sciences
Full name of responsible person
Dr. Glare Heshmati
Position
resident of internal medicine
Other areas of specialty/work
Street address
Amir almomenin hospital, Arak University of Medical Scienses
City
Arak
Postal code
Phone
+98 86 1223 5605
Fax
Email
dr.heshmati@arakMM.ac.ir
Web page address

Person responsible for scientific inquiries

Contact
Name of organization / entity
Arak university of medical sciences
Full name of responsible person
Dr. Mohammad Reza Rezvanfar
Position
Endocrinologist
Other areas of specialty/work
Street address
Vali asr hospital, Arak University of Medical Scienses
City
Arak
Postal code
Phone
+98 86 1222 2004
Fax
Email
daesmaili@gmail.com
Web page address

Person responsible for updating data

Contact
Name of organization / entity
Arak university of medical sciences
Full name of responsible person
Dr. Akram Esmaili
Position
GP
Other areas of specialty/work
Street address
Arak university of medical sciences
City
Arak
Postal code
Phone
+98 86 1223 5605
Fax
Email
daesmaili@gmail.com
Web page address

Sharing plan

Deidentified Individual Participant Data Set (IPD)
empty
Study Protocol
empty
Statistical Analysis Plan
empty
Informed Consent Form
empty
Clinical Study Report
empty
Analytic Code
empty
Data Dictionary
empty
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