Determining the Effect of L-Arginine Supplementation on Hypogonadism in Men with Type 2 Diabetes
Design
Clinical Trial with Control Group, Parallel Group, Double-Blind, Randomized, in which Patients will be Randomly divided into Two Equal Groups (n=25). Block Randomization Method (Quadruple Block) will be used for Randomization.
Settings and conduct
Controlled Clinical Trial, Parallel Group, in which Patients will be Randomly divided into Tow Equal Groups. The Intervention Group will be given Oral L-Arginine and the Control Group will be given a Placebo. Patients will be divided in such a Way that only the Physician Treating the Patient's Diabetes is Aware of the Division and the Researcher and the Patient and the Statistical Expert are not Aware of the Division until the End of the Study.
Participants/Inclusion and exclusion criteria
Inclusion Criteria: Erectile Dysfunction, Diabetes, HBA1C between 5.5 to 7, Age 40 to 60 Years; No Entry Conditions: Patients with Prostate cancer or Hyperplasia, Liver or Kidney Failure, Cardiopulmonary disease, Psychological disease
Intervention groups
The Intervention Group will be treated with Oral L-Arginine Supplement at a Rate of 3 Grams per Day (with BSK Brand made by Iran Zist Takhmir Company) and the Control Group will be treated with Placebo with Similar Form and Color of Drug (BSK Brand made by Iran Zist Takhmir Company).
Main outcome variables
Determining the Score of Erectile Dysfunction based on the International Questionnaire of Erectile Dysfunction 5, Free and Total Testosterone Serum Levels
General information
Reason for update
Acronym
IRCT registration information
IRCT registration number:IRCT20220112053700N1
Registration date:2022-02-12, 1400/11/23
Registration timing:registered_while_recruiting
Last update:2022-02-12, 1400/11/23
Update count:0
Registration date
2022-02-12, 1400/11/23
Registrant information
Name
Mohammad reza Naderi
Name of organization / entity
Country
Iran (Islamic Republic of)
Phone
+98 86 3222 4476
Email address
reza.naderi1988@yahoo.com
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2022-02-12, 1400/11/23
Expected recruitment end date
2022-03-14, 1400/12/23
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
The Effect of L-Arginine Supplementation on Hypogonadism in Patients witht Diabetes Type 2.
Public title
The Effect of L-Arginine Supplementation on Hypogonadism in Patients witht Diabetes Type 2.
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria:
Male Gender
Erectile Dysfunction (ED) for at Least 3 Months
Having Type 2 Diabetes for at Least a Year
Total Testosterone Levels Less than 8 nanomol /Liter or Serum Testosterone in the Range of 8 to 11 nanomol /Liter and Free Testosterone Levels Less than 220 picomoles /Liter
Age 40 to 60 Years
HBA1C Between 5.5 and 7 (Low and Moderate Risk Diabetes)
Do not Take Exogenous Anabolic Steroids
Exclusion criteria:
Patients with Erectile Dysfunction (ED) of known Psychological Origin
Patients with Prostate Cancer or Benign Prostatic Hyperplasia
Patients with a History of Sleep Apnea
Patients with Spinal Cord Injury
Patients with known and treated Cardiopulmonary Injury
Patients with Hyperthyroidism or Hypothyroidism
Patients with known Liver Failure
Patients with known Renal Failure
Patients with a History of Seizures
Patients with known Microvascular Complications of Diabetes (Retinopathy, Neuropathy, Nephropathy
Taking Anti-Libido Drugs
Taking Antipsychotic or Mood Stabilizing or Antidepressant Medications
Age
From 40 years old to 60 years old
Gender
Male
Phase
3
Groups that have been masked
Participant
Investigator
Outcome assessor
Data analyser
Data and Safety Monitoring Board
Sample size
Target sample size:
50
Randomization (investigator's opinion)
Randomized
Randomization description
Participants will be Randomly Assigned to Groups A and B by Block Randomization (Quadruple Block). Due to Having Two Intervention and Control Groups, in each Block, There should be an Equal Number of Modes A and B, which According to the Volume of the Four Blocks, there will be Six Different Modes for the Blocks, which are: AABB, ABAB, ABBA BBAA, BABA, BAAB. Different States of the Blocks will be written on Cardboard Cards of the Same Size and Color. According to the Sample Size (50 Patients) and Five Modes of Blocks, 10 Times the Cards were Randomly Selected by Replacing and Selecting the Blocks, Determining the order of Placing Patients in Groups A (Control) and B (Intervention) will do And According to the Sample Size, the Patients with the Inclusion Criteria will be divided in such a way that only the physician treating the patient's diabetes is aware of the division and the researcher (student) and the Patient and the Statistical Expert are not Aware of the Division until the end of the Study.
Blinding (investigator's opinion)
Double blinded
Blinding description
Eligible Patients will be Divided in such a way that only the Physician Treating the Patient's Diabetes is Aware of the Classification and the Researcher (Student) and the Patient and the Statistical Expert are not Aware of the Classification until the end of the Study.
Placebo
Used
Assignment
Parallel
Other design features
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Ethics Committee of Arak University of Medical Sciences
Street address
No.31, Mahdie St., Imam Khomeini St
City
Arak
Province
Markazi
Postal code
3814955756
Approval date
2022-01-16, 1400/10/26
Ethics committee reference number
IR.ARAKMU.REC.1400.294
Health conditions studied
1
Description of health condition studied
Diabetes Type 2
ICD-10 code
E08
ICD-10 code description
Diabetes mellitus due to underlying condition
Primary outcomes
1
Description
Percentage of Individuals with the International Index of Erectile Function-5 Questionnaire Score of Less than 21
Timepoint
Filling in the Questionnaire at the Beginning of the Study and 8 Weeks after Taking L-Arginine Supplement or Placebo
Method of measurement
The International Index of Erectile Function-5
2
Description
Free and Total Testosterone Serum Levels
Timepoint
Measurement of Free and Total Testosterone Serum Levels at the Beginning of the Study and 8 Weeks after Taking L-Arginine Supplement or Placebo
Method of measurement
Laboratory Kit by ELISA Method
Secondary outcomes
1
Description
Fasting Blood Suger
Timepoint
Measurement of Fasting Blood Sugar Levels at the Beginning of the Study and 8 Weeks after Taking L-Arginine Supplement or Placebo
Method of measurement
Laboratory Kit by ELISA Method
2
Description
Hemoglobin A1C
Timepoint
Measurement of Hemoglobin A1C Levels at the Beginning of the Study and 8 Weeks after Taking L-Arginine Supplement or Placebo
Method of measurement
Laboratory Kit by ELISA Method
Intervention groups
1
Description
Intervention group:All Patients Selected from the Intervention Group Should be Treated with Oral L-Arginine Supplement Alone or dissolved in a Beverage or Liquid Food at a rate of 3 Gram per Day (Oral L-Arginine Vial with BSK Brand made by Iran Zist Takhmir Company) The will Continue for 8 Weeks and at the End of each Week the Method of Taking the Drug and Possible Complications and Problems will be Followed up by Phone.
Category
Treatment - Drugs
2
Description
Control group: All Patients in the Control Group will be treated with a Placebo Vial and a Similar Shape and Colore of the Drug at the rate of 3Gram per Day(with BSK Brand made by Iran Zist Takhmir Company) and will be followed Exactly by the Intervention Group by a Student who does not know how to Assign Groups.
Category
Treatment - Drugs
Recruitment centers
1
Recruitment center
Name of recruitment center
Imam Reza Diabetes Clinic
Full name of responsible person
Bahman Sadeghi
Street address
No.31, Mahdie St., Imam Khomeini St.
City
Arak
Province
Markazi
Postal code
3814955756
Phone
+98 86 3222 4476
Email
Reza.naderi1988@yahoo.com
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Arak University of Medical Sciences
Full name of responsible person
Amir Almasi
Street address
No2.,Basij Square
City
Arak
Province
Markazi
Postal code
3848176941
Phone
+98 86 3313 6055
Email
modavem@arakmu.ac.ir
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
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
Arak University of Medical Sciences
Full name of responsible person
Bahman Sadehgi
Position
Assistant Professor
Latest degree
Specialist
Other areas of specialty/work
Public Health/Community Medicine
Street address
No.31,Mahdie St.,Imam Khomeini St
City
Arak
Province
Markazi
Postal code
3814955756
Phone
+98 86 3222 4476
Email
Reza.naderi1988@yahoo.com
Person responsible for scientific inquiries
Contact
Name of organization / entity
Arak University of Medical Sciences
Full name of responsible person
Bahman Sadeghi
Position
Assistant Professor
Latest degree
Specialist
Other areas of specialty/work
Public Health/Community Medicine
Street address
No.31., Mahdie St., Imam Khomeini St
City
Arak
Province
Markazi
Postal code
3814955756
Phone
+98 86 3222 4476
Email
Reza.naderi1988@yahoo.com
Person responsible for updating data
Contact
Name of organization / entity
Arak University of Medical Sciences
Full name of responsible person
Bahman Sadeghi
Position
Assistant Professor
Latest degree
Specialist
Other areas of specialty/work
Public Health/Community Medicine
Street address
No.31,. Mahdie St., Imam Khomeini St
City
Arak
Province
Markazi
Postal code
3814955756
Phone
+98 86 3222 4476
Email
Reza.naderi1988@yahoo.com
Sharing plan
Deidentified Individual Participant Data Set (IPD)
No - There is not a plan to make this available
Justification/reason for indecision/not sharing IPD
Due to the Privacy of the Information, Patient Information is kept Confidential by the Project Manager.