Investigate the effects of combined pentoxifylline with angiotensin receptor inhibitor in diabetic nephropathy
Design
Sixty DM type 2 patients with urinary albumin / creatinine ratio > 300 mg / g were included in the study. The randomization method is simple allocation (coin toss) and the randomization unit is individual. The clinical trial will consist of two intervention groups: losartan treatment with pentoxifylline and control group: losartan treatment. This study is a single-blind, randomized trial.
Settings and conduct
Patients with DM2 treated with insulin and oral agent who have been referred to endocrinology or nephrology clinic of Vali-e-Asr Hospital in Zanjan due to albuminuria and who have no contraindication to use pentoxifylline enter the study. Patients will be blinded so they won't know the type of group they will be in.
Participants/Inclusion and exclusion criteria
Inclusion criteria: Type 2 diabetes treated with insulin and oral medication with GFR above 30 and albuminuria above 300 mg / g despite receiving losartan during the last three months.
Non-inclusion criteria: patient dissatisfaction; Type 1 diabetes; Hypersensitivity to pentoxifylline;
GFR <30; pregnancy.
Intervention groups
Intervention group: Add pentoxifylline to losartan (losartan 50 mg twice daily and pentoxifylline 400 twice daily) for 3 months.
Control group: Continue treatment with losartan alone (losartan 50 mg twice daily) for 3 months.
Main outcome variables
Albuminuria
General information
Reason for update
Acronym
IRCT registration information
IRCT registration number:IRCT20190806044451N2
Registration date:2021-01-09, 1399/10/20
Registration timing:retrospective
Last update:2021-01-09, 1399/10/20
Update count:0
Registration date
2021-01-09, 1399/10/20
Registrant information
Name
Farzane Karimi
Name of organization / entity
Country
Iran (Islamic Republic of)
Phone
+98 24 3377 0758
Email address
metabolic1397@gmail.com
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2019-07-13, 1398/04/22
Expected recruitment end date
2020-06-11, 1399/03/22
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Evaluation of the effects of combination therapy of pentoxifylline and losartan in comparison with losartan alone on diabetic nephropathy
Public title
Efficacy of Pentoxifylline in diabetic nephropathy
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria:
Type 2 diabetic patients treated with insulin and oral agents
GFR above 30 cc / min / 1.73 m2
albuminuria above 300 mg/g
Exclusion criteria:
Patient dissatisfaction
Type 1 diabetes
Pentoxifylline allergy
Chronic heart failure
Uncontrolled hypertension
Other medicines that affect albuminuria
Cerebral hemorrhage
Extensive retinal hemorrhage
ESRD, GFR <30
Pregnancy
Hyperkalemia (high potassium) 5.5 before or during the study)
Age
No age limit
Gender
Both
Phase
3
Groups that have been masked
Participant
Sample size
Target sample size:
60
Randomization (investigator's opinion)
Randomized
Randomization description
The randomization method in this study is simple randomization and the randomization unit is also individual. Subjects in this study will be divided into control (losartan treatment) and intervention (losartan treatment with pentoxifylline) groups using coin throwing (coin toss) method.
Blinding (investigator's opinion)
Single blinded
Blinding description
This study is single blind and the patient will be explained about the cause of administration and the effect and side effects of the prescribed drug. The two groups will not be in relationship with each other and the the name of pentoxifylline will not be said to the control group.
Placebo
Not used
Assignment
Parallel
Other design features
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Ethics Committee of Zanjan University of Medical Sciences
Street address
Metabolic dieases research center, Vali-e-asr hospital, Sheikh Fazlollah street
City
Zanjan
Province
Zanjan
Postal code
4515613191
Approval date
2019-07-13, 1398/04/22
Ethics committee reference number
IR.ZUMS.REC.1398.158
Health conditions studied
1
Description of health condition studied
Type 2 Diabetes
ICD-10 code
E11
ICD-10 code description
Type 2 diabetes mellitus
2
Description of health condition studied
Diabetic Nephropathy
ICD-10 code
N00-N08
ICD-10 code description
بیماریهای گلومرولی
Primary outcomes
1
Description
Random Urin Albumin/Creatinine
Timepoint
3 months before intervention and before starting pentoxifylline and 3 months after starting pentoxifylline
Method of measurement
Lab test
Secondary outcomes
1
Description
Creatinin
Timepoint
Before starting pentoxifylline and 3 months after starting pentoxifylline
Method of measurement
Lab test
2
Description
Hemoglobin A1c
Timepoint
Before starting pentoxifylline and 3 months after starting pentoxifylline
Method of measurement
Lab test
3
Description
Blood pressure
Timepoint
Before starting pentoxifylline and 3 months after starting pentoxifylline
Method of measurement
Sphygmomanometer
4
Description
Body mass index
Timepoint
Before starting pentoxifylline and 3 months after starting pentoxifylline
Method of measurement
meter & Balance
5
Description
Fasting blood sugar (FBS)
Timepoint
Before starting pentoxifylline and 3 months after starting pentoxifylline
Method of measurement
Lab test
6
Description
Pentoxifylline Complications
Timepoint
Before starting pentoxifylline and 3 months after starting pentoxifylline
Method of measurement
History taking
Intervention groups
1
Description
Intervention group: Add oral Pentoxifylline 400 mg (twice daily) to oral Losartan 50 mg (twice daily) for 3 months.
Category
Treatment - Drugs
2
Description
Control group: Continue treatment with oral Losartan 50 mg twice daily for 3 months
Category
Treatment - Drugs
Recruitment centers
1
Recruitment center
Name of recruitment center
Valiasr Hospital
Full name of responsible person
Somayeh Jalali
Street address
Metabolic diseases researchs center, Valiasr Hospital, Shariati blvd
City
Zanjan
Province
Zanjan
Postal code
4515777978
Phone
+98 24 3377 0758
Email
somayehjalali10@yahoo.com
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Zanjan University of Medical Sciences
Full name of responsible person
Dr Alireza Shoghli
Street address
Metabolic diseases researchs center, Valiasr hospital, Shariati blvd , Zanjan
City
Zanjan
Province
Zanjan
Postal code
4515777978
Phone
+98 24 3377 0758
Email
somayehjalali10@yahoo.com
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Zanjan 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
Zanjan University of Medical Sciences
Full name of responsible person
Somayeh Jalali
Position
Resident
Latest degree
Medical doctor
Other areas of specialty/work
Internal Medicine
Street address
Metabolic diseases researchs center ,Valiasr hospital, Shariati blvd, Zanjan
City
Zanjan
Province
Zanjan
Postal code
4515777978
Phone
+98 24 3377 0758
Email
somayehjalali10@yahoo.com
Person responsible for scientific inquiries
Contact
Name of organization / entity
Zanjan University of Medical Sciences
Full name of responsible person
Somayeh Jalali
Position
Resident
Latest degree
Medical doctor
Other areas of specialty/work
Internal Medicine
Street address
Metabolic diseases research center, Valiasr Hospital, Shariati blvd.
City
zanjan
Province
Zanjan
Postal code
4515777978
Phone
+98 24 3377 0758
Email
somayehjalali10@yahoo.com
Person responsible for updating data
Contact
Name of organization / entity
Zanjan University of Medical Sciences
Full name of responsible person
Farzaneh Karimi
Position
Research Expert
Latest degree
Master
Other areas of specialty/work
Biostatistics
Street address
Metabolic diseases research center, Valiasr Hospital, Shariati blvd.
City
Zanjan
Province
Zanjan
Postal code
4515777978
Phone
+98 24 3377 0758
Fax
Email
metabolic1397@gmail.com
Sharing plan
Deidentified Individual Participant Data Set (IPD)
Yes - There is a plan to make this available
Study Protocol
Yes - There is a plan to make this available
Statistical Analysis Plan
Yes - There is a plan to make this available
Informed Consent Form
Yes - There is a plan to make this available
Clinical Study Report
Yes - There is a plan to make this available
Analytic Code
Yes - There is a plan to make this available
Data Dictionary
No - There is not a plan to make this available
Title and more details about the data/document
All potential data can be shared after making people unidentifiable
When the data will become available and for how long
Start access period 3 months after publishing the results
To whom data/document is available
It will only be available to researchers working in academic and scientific institutions
Under which criteria data/document could be used
With the written and official permission of the researcher or supervisor, access to all documents will be possible
From where data/document is obtainable
Contact those in charge through these numbers 09146592655- 02433770758.
Email: somayehjalali10@yahoo.com.
Corresponding Address: Metabolic Disorders Research Center, Valiasr Hospital, Zanjan, Iran
What processes are involved for a request to access data/document
1) Contact the person in charge or the researcher and coordinate.
2) Submit request by email or letter.
This may take at least a month to access the data.