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Effects of pentoxyfilline on serum markers of diabetic nephropathy in patients with type2 diabetes

Protocol summary

Study aim
To assess effects of pentoxifylline on serum copeptin, osteopontin, cystatinc, HSP70, bilirubin, uric acid, adiponectin, resistin, hs-CRP, TNFα, Apo A, Apo B and the urinary albumin excretion (UAE) rate in patients with type 2 diabetes with nephropathy.
Design
This is a randomized double-blind clinical trial study on 70 patients with type2 diabetes with proteinuria in two groups randomly; including pentoxifylline add on losartan and control group with increasing dose of losartan. Drugs will prescribe to each group for 12 weeks.
Settings and conduct
This is a randomized clinical trial study on patients with type2 diabetes. patients will be randomly divided into 2 groups. Before treatment and after 12 week blood samples will be taken. All samples will be analyzed by standard methods. This study will be conducted at diabetes clinic of the vali-asr hospital in Tehran University of Medical Sciences.
Participants/Inclusion and exclusion criteria
Inclusion criteria: patients with type2 diabetes with proteinuria. Exclusion criteria are infectious or malignant diseases, non-diabetic kidney disease, retinal hemorrhage, acute myocardial infarction or unstable angina, history of cardiocerbrovascular or peripheral artery disease, uncontrolled hypertension (i.e., systolic blood pressure [SBP] ≥ 140mmHg and/or diastolic blood pressure [DBP] ≥ 90 mmHg) , pregnancy, anemia, hyperthyroidism, history of hemodialysis, baseline serum potassium concentrations ≥5.5 meq/L, estimated glomerular filtration rate (eGFR) < 30mL/minute/1.73 m and pentoxifylline intolerance.
Intervention groups
patients with type2 diabetes with proteinuria in two groups including pentoxifylline add on losartan or increased dosage of losartan
Main outcome variables
serum copeptin, osteopontin, cystatin C, HSP70, bilirubin, uric acid, adiponectin, resistin, hs-CRP, TNFα, Apo A, Apo B and the urinary albumin excretion (UAE) rate

General information

Reason for update
Acronym
IRCT registration information
IRCT registration number: IRCT20121104011356N10
Registration date: 2020-04-14, 1399/01/26
Registration timing: registered_while_recruiting

Last update: 2020-04-14, 1399/01/26
Update count: 0
Registration date
2020-04-14, 1399/01/26
Registrant information
Name
Alireza Esteghamati
Name of organization / entity
Tehran University of Medical Sciences
Country
Iran (Islamic Republic of)
Phone
+98 21 8841 7918
Email address
esteghamati@tums.ac.ir
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2020-04-03, 1399/01/15
Expected recruitment end date
2020-06-04, 1399/03/15
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Effects of pentoxyfilline on serum markers of diabetic nephropathy in patients with type2 diabetes
Public title
Effects of pentoxyfilline diabetic nephropathy
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria:
type2 diabetes according to American Diabetes Association (ADA 2019) with proteinuria
Exclusion criteria:
infectious or malignant diseases non-diabetic kidney disease retinal hemorrhage acute myocardial infarction or unstable angina history of cardio-cerbro-vascular or peripheral artery disease uncontrolled hypertension (i.e., systolic blood pressure [SBP] ≥ 140mmHg and/or diastolic blood pressure [DBP] ≥ 90 mmHg) pregnancy anemia hyperthyroidism history of hemodialysis baseline serum potassium concentrations ≥5.5 meq/L estimated glomerular filtration rate (eGFR) < 30mL/minute/1.73 m and pentoxifylline intolerance
Age
From 40 years old to 65 years old
Gender
Both
Phase
3
Groups that have been masked
No information
Sample size
Target sample size: 70
Randomization (investigator's opinion)
Randomized
Randomization description
patients will be randomized with random table number.
Blinding (investigator's opinion)
Not blinded
Blinding description
Placebo
Not used
Assignment
Parallel
Other design features

Secondary Ids

empty

Ethics committees

1

Ethics committee
Name of ethics committee
Ethics committee of National Institute for Medical Research Development
Street address
No 21, Besat Ave, West Fatemi Blvd,Tehran
City
tehran
Province
Tehran
Postal code
۱۴۱۹۶۹۳۱۱۱
Approval date
2019-08-25, 1398/06/03
Ethics committee reference number
IR.NIMAD.REC.1398.193

Health conditions studied

1

Description of health condition studied
diabetic nephropathy
ICD-10 code
E11.21
ICD-10 code description
Type 2 diabetes mellitus with diabetic nephropathy

Primary outcomes

1

Description
Copeptin
Timepoint
before treatment and after 12 weeks
Method of measurement
Copeptin will be measured using a quantitative sandwich ELISA immunoassay

2

Description
osteopontin
Timepoint
before treatment and after 12 weeks
Method of measurement
Osteopontin will be measured using a quantitative sandwich ELISA

3

Description
cystatin c
Timepoint
before treatment and after 12 weeks
Method of measurement
cystatin c will be measured using a quantitative sandwich ELISA

4

Description
HSP70
Timepoint
before treatment and after 12 weeks
Method of measurement
HSP70 will be measured using a quantitative sandwich ELISA

5

Description
Bilirubin
Timepoint
before treatment and after 12 weeks
Method of measurement
Bilirubin will be measured using an enzymatic assay

6

Description
Uric acid
Timepoint
before treatment and after 12 weeks
Method of measurement
Uric acid will be measured using an enzymatic assay

7

Description
Apo A
Timepoint
before treatment and after 12 weeks
Method of measurement
Apo A will be measured using a quantitative sandwich ELISA

8

Description
Apo B
Timepoint
before treatment and after 12 weeks
Method of measurement
Apo B will be measured using a quantitative sandwich ELISA

9

Description
adiponectin
Timepoint
before treatment and after 12 weeks
Method of measurement
Adiponectin will be measured using a quantitative sandwich ELISA

10

Description
Resistin
Timepoint
before treatment and after 12 weeks
Method of measurement
Adiponectin will be measured using a quantitative sandwich ELISA

11

Description
hs-CRP
Timepoint
before treatment and after 12 weeks
Method of measurement
hs-CRP will be measured using a quantitative sandwich ELISA

12

Description
TNFα
Timepoint
before treatment and after 12 weeks
Method of measurement
TNFα will be measured using a quantitative sandwich ELISA

Secondary outcomes

empty

Intervention groups

1

Description
Intervention group: pentoxifylline 400 mg daily for 12 week
Category
Treatment - Drugs

2

Description
Control group: هncreasing dose of losartan 50 mg daily for 12 week
Category
Treatment - Drugs

Recruitment centers

1

Recruitment center
Name of recruitment center
Vali-Asr Hospital
Full name of responsible person
Professor Alireza Esteghamati
Street address
No 20, Keshavarz Blvd, Tehran, Iran
City
Tehran
Province
Tehran
Postal code
13145-784
Phone
+98 21 8884 1791
Email
esteghamati@tums.ac.ir

Sponsors / Funding sources

1

Sponsor
Name of organization / entity
National Institute for Medical Research Development
Full name of responsible person
Alireza esteghamati
Street address
No20, Besat Ave, West Fatemi Blv, Tehran, iran
City
Tehran
Province
Tehran
Postal code
1419693111
Phone
+98 21 6690 0920
Email
NIMAD@RESEARCH.AC.IR
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
National Institute for Medical Research Development
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
Tehran University of Medical Sciences
Full name of responsible person
manouchehr nakhjavani
Position
professor
Latest degree
Subspecialist
Other areas of specialty/work
endocrinology and metabolism
Street address
No. 21, Vali-Asr hospital, Keshavarz Blv, Tehran, Iran
City
Tehran
Province
Tehran
Postal code
14197-33147
Phone
+98 21 6691 1294
Email
nakhjavanim@tums.ac.ir

Person responsible for scientific inquiries

Contact
Name of organization / entity
Tehran University of Medical Sciences
Full name of responsible person
Alireza Esteghamati
Position
Professor
Latest degree
Subspecialist
Other areas of specialty/work
Endocrinology and metabolism
Street address
No. 21, Vali-Asr hospital, Keshavarz Blv, Tehran, Iran
City
Tehran
Province
Tehran
Postal code
14197-33147
Phone
+98 21 8841 7918
Email
esteghamati@tums.ac.ir

Person responsible for updating data

Contact
Name of organization / entity
Tehran University of Medical Sciences
Full name of responsible person
Soghra Rabizadeh
Position
Assistant Professor
Latest degree
Subspecialist
Other areas of specialty/work
Endocrinology and metabolism
Street address
No. 21, Vali-Asr hospital, Keshavarz Blv, Tehran, Iran
City
Tehran
Province
Tehran
Postal code
14197-33147
Phone
+98 21 6691 1294
Email
rabizadeh@sina.tums.ac.ir

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
Given the confidentiality of the information of the patients participating in this study, I do not intend to publish the participants' data files.
Study Protocol
No - There is not a plan to make this available
Statistical Analysis Plan
No - There is not a plan to make this available
Informed Consent Form
No - There is not a plan to make this available
Clinical Study Report
No - There is not a plan to make this available
Analytic Code
No - There is not a plan to make this available
Data Dictionary
No - There is not a plan to make this available
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