The objective of this study is to determine the Effect of L-Argenine supplementation on sexual function in men with type 2 diabetes. This is a double blind study. Considering the 10 percent of flux, the sample size is 80. Patients will be randomly assigned into 2 groups, intervention and control group. The intervention group will take 5 gr/day of L-Arginine and the control group will take 5 gr/day of Methyl Cellulose(as placebo) for 4 weeks. At the beginning and end of the study, patients will be examined in terms of sexual function through the international index of erectile function (IIEF) questionnaire.
General information
Acronym
Argenine
IRCT registration information
IRCT registration number:IRCT2015050322076N1
Registration date:2015-08-04, 1394/05/13
Registration timing:registered_while_recruiting
Last update:
Update count:0
Registration date
2015-08-04, 1394/05/13
Registrant information
Name
Mohammad Hassan Rouhani
Name of organization / entity
Isfahan University of Medical Sciences
Country
Iran (Islamic Republic of)
Phone
+98 31 3668 5770
Email address
sm_rouhani@nutr.mui.ac.ir
Recruitment status
Recruitment complete
Funding source
Department of Health, Yazd Shahid Sadoughi University of Medical Sciences
Expected recruitment start date
2014-03-20, 1392/12/29
Expected recruitment end date
2015-08-12, 1394/05/21
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Effect of L.Argenine oral supplementation on sexual function in men with type 2 diabetes
Public title
The effect of arginine on sexual function in men with diabetes
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria: being married; patients with mild to moderate erectile dysfunction (according to the score 15 to 25 obtained from the questionnaire of international index of erectile function (IIEF)); age between 25 to 55 years; a minimum of 5 years experience in diabetes.
exclusion criteria: unstable cardiovascular status (angina and heart attack experience); cancer chemotherapy; those how taking reduced medications and secretion of androgen; surgery in the pelvic or prostate area; lack of personal satisfaction to log in to study; insulin users; consumers of opium and any apparent disorders of the genital system by endocrinologist assumption.
Age
From 25 years old to 55 years old
Gender
Male
Phase
N/A
Groups that have been masked
No information
Sample size
Target sample size:
80
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
Shahid Sadoughi University of Medical Sciences
Street address
Department of Health,Shahid Sadoughi University of Medical Sciences, Hesabi Blvd
City
yazd
Postal code
Approval date
2013-07-29, 1392/05/07
Ethics committee reference number
17/1/81417/پ
Health conditions studied
1
Description of health condition studied
sexual dysfunction
ICD-10 code
F52.0
ICD-10 code description
Lack or loss of sexual desire
Primary outcomes
1
Description
sexual function
Timepoint
Before intervention and 4 weeks after intervention
Method of measurement
IIEF Questionnaire
Secondary outcomes
1
Description
Concentration of total testosterone
Timepoint
Before the intervention and after completion of the intervention
Method of measurement
Laboratory method Radio Immuno assay
Intervention groups
1
Description
The intervention group will take five grams of oral l-arginine in a 5 grams package for 28 days.
Category
Treatment - Drugs
2
Description
The control group will take five grams of oral Methyl Cellulose in 5 grams packages for 28 days
Category
Placebo
Recruitment centers
1
Recruitment center
Name of recruitment center
Yazd Diabetes Research Center
Full name of responsible person
Dr Hasan Mozaffari Khosravi
Street address
Diabetes Center, Talare Honar alley, Bahonar square
City
yazd
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Yazd Shahid Sadoughi University of Medical Sciences
Full name of responsible person
Dr Hasan Mozaffari Khosravi
Street address
Department of Health, Alem square
City
yazd
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Yazd Shahid Sadoughi 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
Yazd Shahid Sadoughi University of Medical Sciences
Full name of responsible person
Mosayeb Fallahi
Position
Student of MSc Health Sciences in Nutrition
Other areas of specialty/work
Street address
Graduate Units,Department of Health,Shahid Sadoughi University of Medical Sciences, Hesabi Blvd
City
yazd
Postal code
Phone
+98 35 3623 8505
Fax
Email
mosayebfalahy@yahoo.com
Web page address
Person responsible for scientific inquiries
Contact
Name of organization / entity
Yazd Shahid Sadughi University of Medical Sciences
Full name of responsible person
Hasan Mozaffari Khosravi
Position
PhD in Nutritional Sciences
Other areas of specialty/work
Street address
Graduate Units,Department of Health,Shahid Sadoughi University of Medical Sciences, Hesabi Blvd
City
yazd
Postal code
Phone
+98 35 3623 8505
Fax
Email
MOZAFFARI.KH@GMAIL.COM
Web page address
Person responsible for updating data
Contact
Name of organization / entity
Yazd Shahid Sadughi University of Medical Sciences
Full name of responsible person
Mosayeb Fallahi
Position
Student of MSc Health Sciences in Nutrition
Other areas of specialty/work
Street address
Graduate Units,Department of Health,Shahid Sadoughi University of Medical Sciences, Hesabi Blvd
City
yazd
Postal code
Phone
+98 35 3623 8505
Fax
Email
mosayebfalahy@yahoo.com
Web page address
Sharing plan
Deidentified Individual Participant Data Set (IPD)