Determining the therapeutic effect of testosterone on lipid profile in patients with chronic kidney disease
Design
single arm clinical trial
Settings and conduct
Patients attending to nephrology clinic will underwent fasting blood test for Total cholestrol, LDL, HDL, Triglycerid. 20 patients with low serum testosterone (less than 3.5 ng/ml) willtake IM injection of Testosterone enanthate 100 mg every 2 weeks for 3 months.Then bood samplig will be repeated for lipid profile. All demographic and labratory data will be recorded in each individual questionnaire.
Participants/Inclusion and exclusion criteria
40 to 60 years old Men suffering CKD with GFR less than 45 or ESRD and BMI between 35 to 40 without any pithuitary disease, liver or thyroid dysfunction.
Intervention groups
IM injection of Testosterone enanthate 100 mg every 2 weeks for 3 months
Main outcome variables
Total cholestrol; LDL; HDL; Triglyceride
General information
Reason for update
Acronym
CKD
IRCT registration information
IRCT registration number:IRCT20191009045044N1
Registration date:2019-12-26, 1398/10/05
Registration timing:retrospective
Last update:2019-12-26, 1398/10/05
Update count:0
Registration date
2019-12-26, 1398/10/05
Registrant information
Name
Azadeh Kameli
Name of organization / entity
Country
Iran (Islamic Republic of)
Phone
+98 45 3351 1238
Email address
a.kameli@arums.ac.ir
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2019-09-07, 1398/06/16
Expected recruitment end date
2019-09-23, 1398/07/01
Actual recruitment start date
2019-09-08, 1398/06/17
Actual recruitment end date
2019-10-09, 1398/07/17
Trial completion date
2020-01-20, 1398/10/30
Scientific title
The therapeutic effect of testosterone on lipid profile in patients with chronic kidney disease and low testestrone level
Public title
The therapeutic effect of testosterone on lipid profile in patients with chronic kidney disease
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria:
GFR less than 45
BMI 25 to30
Male Gender
Testestrone lower than 3.5 ng/lit
Exclusion criteria:
Any pituitery diseas
Liver dysfunction
Heart failure
Any thyroid disease
Using any fat depressors
Prostate cancer
Breast cancer
BPH with obstruction
Age
From 40 years old to 60 years old
Gender
Male
Phase
3
Groups that have been masked
No information
Sample size
Target sample size:
20
Actual sample size reached:
20
Randomization (investigator's opinion)
N/A
Randomization description
Blinding (investigator's opinion)
Not blinded
Blinding description
Placebo
Not used
Assignment
Single
Other design features
quasi experimental study
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
NREC
Street address
No1. Daneshgah Blvd., Janbazan Sq., Ardabil town
City
Ardabil
Province
Ardabil
Postal code
5619813944
Approval date
2018-05-13, 1397/02/23
Ethics committee reference number
IR.ARUMS.REC.1398.316
Health conditions studied
1
Description of health condition studied
Chronic kidney disease
ICD-10 code
N18
ICD-10 code description
Chronic kidney disease (CKD)
Primary outcomes
1
Description
Total Cholestrol
Timepoint
First of study and 3 months later
Method of measurement
Lab test
2
Description
Serum Triglyceride
Timepoint
First of study and 3 months later
Method of measurement
Lab test
3
Description
LDL Cholestrol
Timepoint
First of study and 3 months later
Method of measurement
Lab test
4
Description
HDL Cholestrol
Timepoint
First of study and 3 months later
Method of measurement
Lab test
Secondary outcomes
1
Description
Serum Testestrone
Timepoint
At the beginning of the study and three months later
Method of measurement
Lab test
Intervention groups
1
Description
Intervention group: IM injection of Testosterone enanthate 100, (each ampoule 1 ml contains Teastosterone Enanthate 100 mg) every 2 weeks for 3 months. Each patient recieves 6 injections.
Category
Treatment - Drugs
Recruitment centers
1
Recruitment center
Name of recruitment center
Imam Khomeini hospital, Nephrology clinic
Full name of responsible person
Bahman Bashardoust
Street address
Noi´aghdam Ave.
City
Ardabil
Province
Ardabil
Postal code
5619647531
Phone
+98 45 3325 1401
Email
b-bashardoust@yahoo.com
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Ardabil University of Medical Sciences
Full name of responsible person
Ghodrat Akhavan Akbari
Street address
Daneshgah Ave.
City
Ardabil
Province
Ardabil
Postal code
5618985991
Phone
+98 45 3352 2247
Fax
+98 45 3352 2196
Email
research@arums.ac.ir
Web page address
https://www.arums.ac.ir
Grant name
research grant
Grant code / Reference number
129106
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Ardabil 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
Ardabil University of Medical Sciences
Full name of responsible person
Azadeh Kameli
Position
Internal medicine resident
Latest degree
Medical doctor
Other areas of specialty/work
Internal Medicine
Street address
No. 1, Daneshgah Blvd.
City
Ardabil
Province
Ardabil
Postal code
5619813944
Phone
+98 45 3351 1238
Email
kameliazad@gmail.com
Person responsible for scientific inquiries
Contact
Name of organization / entity
Ardabil University of Medical Sciences
Full name of responsible person
Bahman Bashadoust
Position
Associate professor
Latest degree
Subspecialist
Other areas of specialty/work
Nephrology
Street address
Daneshgah Ave.
City
Ardabil
Province
Ardabil
Postal code
5618985991
Phone
+98 45 3325 1401
Email
b-bashardoust@yahoo.com
Person responsible for updating data
Contact
Name of organization / entity
Ardabil University of Medical Sciences
Full name of responsible person
Azadeh Kameli
Position
Resident
Latest degree
Medical doctor
Other areas of specialty/work
Internal Medicine
Street address
No. 1, Daneshgah Blvd.
City
Ardabil
Province
Ardabil
Postal code
5619813944
Phone
+98 45 3351 1238
Email
kameliazad@gmail.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
Confidentiality in medical profession
Study Protocol
Undecided - It is not yet known if there will be a plan to make this available
Statistical Analysis Plan
Undecided - It is not yet known if there will be a plan to make this available
Informed Consent Form
Undecided - It is not yet known if there will be a plan to make this available
Clinical Study Report
Undecided - It is not yet known if there will be a plan to make this available
Analytic Code
Undecided - It is not yet known if there will be a plan to make this available
Data Dictionary
Undecided - It is not yet known if there will be a plan to make this available