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The effect of pioglitazone in improving respiratory and inflammatory markers in patients with diabtes and asthma- clinical trial

Protocol summary

Summary
This study is a clinical trial that designed to assess effect of Pioglitazone in improving respiratory and inflammatory markers in 15 patients (18-75) with diabetes and asthma referred to Yazd Diabetic Research Center. Inclusion criteria: aged between 18 and 50 years, diagnosing asthma at least one year, HbA1C between 8-9, positive test of methacholine or bronchodilator, treated with inhaled corticosteroid at least three months with or without long-acting inhaled bronchodilator, radiography do not show other diseases. Exclusion criteria: hypersensitivity to pioglitazone, receiving oral steroids, smoking during the past three months, respiratory infections within a month before the start of the study , history of pulmonary diseases besides asthma, more than 2+ edema, heart failure, osteopenia or osteoporosis (T-score <-1). Patients will be given pioglitazone tablet 30 microgram daily for three months. markers such as Leptin, CRP and breathing markers such as FEV1 and ratio of FEV1/FVC and exhaled NO before and after treated will be measured.

General information

Acronym
IRCT registration information
IRCT registration number: IRCT2016050827785N1
Registration date: 2016-12-03, 1395/09/13
Registration timing: registered_while_recruiting

Last update:
Update count: 0
Registration date
2016-12-03, 1395/09/13
Registrant information
Name
Fatemeh Sadat Aghayei-Meybodi
Name of organization / entity
Shahid Sadoughi University of Medical Sciences, Yazd
Country
Iran (Islamic Republic of)
Phone
+98 35 3728 0226
Email address
dr.meybodi@ssu.ac.ir
Recruitment status
Recruitment complete
Funding source
Vice Chancellor for Research and Technology Yazd University of Medical Sciences
Expected recruitment start date
2015-03-21, 1394/01/01
Expected recruitment end date
2017-02-19, 1395/12/01
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
The effect of pioglitazone in improving respiratory and inflammatory markers in patients with diabtes and asthma- clinical trial
Public title
The effect of pioglitazone in patients with diabetes and asthma
Purpose
Prevention
Inclusion/Exclusion criteria
Inclusion criteria: aged between 18 and 75 years,diagnosed asthma for at least one year, HbA1C between 8-9, methacholine or bronchodilator positive tests, treated with inhaled corticosteroid for at least three months with or without long-acting inhaled bronchodilator,no other diseases in radiography. Exclusion criteria: hypersensitivity to pioglitazone, receiving oral steroids, smoking during the past three months, respiratory infections within a month before the start of the study , history of pulmonary diseases besides asthma, more than 2+ edema, heart failure, osteopenia or osteoporosis (T-score <-1).
Age
From 18 years old to 75 years old
Gender
Both
Phase
3
Groups that have been masked
No information
Sample size
Target sample size: 15
Randomization (investigator's opinion)
N/A
Randomization description
Blinding (investigator's opinion)
Not blinded
Blinding description
Placebo
Not used
Assignment
Single
Other design features

Secondary Ids

empty

Ethics committees

1

Ethics committee
Name of ethics committee
Ethics committee of ShahidSadoughi University of Medical Sciences, Yazd
Street address
Bahonar Square, Yazd, Central Organization of Shahid Sadoughi University of Yazd Medical Sciences and Health Services
City
Yazd
Postal code
8916978477
Approval date
2014-08-17, 1393/05/26
Ethics committee reference number
17/1/102110

Health conditions studied

1

Description of health condition studied
Diabetes and Asthma
ICD-10 code
E10, E11,
ICD-10 code description
Insulin-dependent diabetes mellitus, Non-insulin-dependent diabetes mellitus, Malnutrition-related diabetes mellitus, Other specified diabetes mellitus, Unspecified diabetes mellitus, Asthma, unspecified

Primary outcomes

1

Description
FEV1
Timepoint
At baseline and three months after the initiation of trial
Method of measurement
Second

2

Description
CRP-Hs
Timepoint
At baseline and three months after the initiation of trial
Method of measurement
Mg/l

3

Description
NO
Timepoint
At baseline and three months after the initiation of trial
Method of measurement
Second

4

Description
Leptin
Timepoint
At baseline and three months after the initiation of trial
Method of measurement
ng/ml

5

Description
Ig E
Timepoint
At baseline and three months after the initiation of trial
Method of measurement
ng/ml

6

Description
FBS
Timepoint
At baseline and three months after the initiation of trial
Method of measurement
Mg/dl

7

Description
2hpp
Timepoint
At baseline and three months after the initiation of trial
Method of measurement
Mg/dl

8

Description
A1C
Timepoint
At baseline and three months after the initiation of trial
Method of measurement
Percent

9

Description
FEV1/FVC
Timepoint
At baseline and three months after the initiation of trial
Method of measurement
Percent

Secondary outcomes

empty

Intervention groups

1

Description
Intervention(Pioglitazone, 30mg/day, For three months)
Category
Treatment - Drugs

Recruitment centers

1

Recruitment center
Name of recruitment center
Yazd Diabetes Research Center
Full name of responsible person
Fatemeh Sadat Aghaye-Meybodi
Street address
Talar Honar Alley, Bahonar Square, Yazd
City
Yazd

Sponsors / Funding sources

1

Sponsor
Name of organization / entity
Vice Chancellor for research of University of Medical Sciences and Health Services, Yazd
Full name of responsible person
Hoshang Mehrparvar
Street address
Bahonar Square, Yazd, Central Organization of Shahid Sadoughi University of Yazd Medical Sciences and Health Services
City
Yazd
Grant name
1255001
Grant code / Reference number
30303000
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Vice Chancellor for research of University of Medical Sciences and Health Services, Yazd
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 Diabetes Research Center
Full name of responsible person
Reihane Azizi
Position
Endocrinologist, Assistant Professor
Other areas of specialty/work
Street address
Tallar Honar Alley, Bahonar Square, Yazd
City
Yazd
Postal code
8917945556
Phone
+98 35 3728 0217
Fax
Email
Raihne.Azizi@yahoo.com
Web page address
http://ijdo@ssu.ac.ir

Person responsible for scientific inquiries

Contact
Name of organization / entity
Yazd Diabetes Research Center
Full name of responsible person
Fatemeh Sadat Aghaye-Meybodi
Position
Endocrinologist, Assistant Professor
Other areas of specialty/work
Street address
Tallar Honar Alley, Bahonar Square, Yazd
City
Yazd
Postal code
8917945556
Phone
+98 35 3728 0217
Fax
Email
Dr.meybodi@yahoo.com
Web page address
http://ijdo@ssu.ac.ir

Person responsible for updating data

Contact
Name of organization / entity
Diabetes Research Center
Full name of responsible person
Saeedeh Jam-Ashkezari
Position
MA.Mycology
Other areas of specialty/work
Street address
Tallar Honar Alley, Bahonar Square, Yazd
City
Yazd
Postal code
8917945556
Phone
+98 35 3728 0217
Fax
Email
saeedehjam@ut.ac.ir
Web page address
http://ijdo@ssu.ac.ir

Sharing plan

Deidentified Individual Participant Data Set (IPD)
empty
Study Protocol
empty
Statistical Analysis Plan
empty
Informed Consent Form
empty
Clinical Study Report
empty
Analytic Code
empty
Data Dictionary
empty
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