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Evaluating the Effects of Inhaled Corticosteroid on Insulin Sensitivity in Asthmatic Patient

Protocol summary

Summary
Asthma is an inflammatory disease, which causes air flow limitation and increase insulin resistance. The present study will carry out in order to investigate insulin resistance and the effect of inhaled corticosteroid (ICS) on insulin resistance in asthmatic patients. the patients with age over 15 years, stage2 or 3 asthma, FEV1 above 60%, no previous use of oral or inhaled corticosteroid and no history of diabetes will participate in this interventional, quasi-experimental study and patients with history of diabetes or malignancy, pregnancy, acute infection, endocrine disorder, taking any medication that affects glucose metabolism, obesity (defined by BMI≥30 kg/m2) and sleep apnea excluded. Spirometry, fasting blood sugar, BS2HPP, HbA1C, LDL, HDL, Insulin Level, and CRP will measure both at the base line and after two months of treatment. Then impaired fasting glucose (IFG) will examine, and HOMA-IR will calculate. patients will receive symbicort inhaler with dose 320 microgram every 12h for two months.

General information

Acronym
Effects of Inhaled Corticosteroid on Insulin Sensitivity
IRCT registration information
IRCT registration number: IRCT201605247411N2
Registration date: 2016-06-27, 1395/04/07
Registration timing: retrospective

Last update:
Update count: 0
Registration date
2016-06-27, 1395/04/07
Registrant information
Name
Hanieh Raji
Name of organization / entity
Imam Khomeini hospital
Country
Iran (Islamic Republic of)
Phone
+98 61 3221 6501
Email address
raji-h@ajums.ac.ir
Recruitment status
Recruitment complete
Funding source
Ahvaz Jundishapur University of Medical Sciences
Expected recruitment start date
2014-07-02, 1393/04/11
Expected recruitment end date
2015-10-31, 1394/08/09
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Evaluating the Effects of Inhaled Corticosteroid on Insulin Sensitivity in Asthmatic Patient
Public title
Does inhaled corticosteroid predispose asthmatic patients to diabetes?
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria included: age over 15 years; stage2 or 3 asthma; FEV1 above 60%; no previous use of oral or inhaled corticosteroid and no history of diabetes. Exclusion criteria included: history of diabetes or malignancy; pregnancy; acute infection; endocrine disorder; taking any medication that affects glucose metabolism; obesity (defined by BMI≥30 kg/m2) and sleep apnea
Age
No age limit
Gender
Both
Phase
3
Groups that have been masked
No information
Sample size
Target sample size: 28
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
Ahvaz Jundishaur university of medical sciences
Street address
Ahvaz University of Sciences, Golestan street, Ahvaz, Iran
City
Ahvaz
Postal code
Iran
Approval date
2011-11-19, 1390/08/28
Ethics committee reference number
ETH-288

Health conditions studied

1

Description of health condition studied
Chronic lower respiratory diseases
ICD-10 code
J45
ICD-10 code description
Asthma

Primary outcomes

1

Description
FBs, BS2HPP, HbA1C, LDL, HDL, Insulin Level, CRP and HOMA-IR
Timepoint
at the beging of study and two months later
Method of measurement
examination

Secondary outcomes

1

Description
FEV1, FVC, FEV1/FVC
Timepoint
At the begining of study and two months later
Method of measurement
Spirometry device

Intervention groups

1

Description
Inhaled corticosteroid
Category
Treatment - Drugs

Recruitment centers

1

Recruitment center
Name of recruitment center
Imam Khomeini
Full name of responsible person
Street address
City
Ahvaz

Sponsors / Funding sources

1

Sponsor
Name of organization / entity
Ahvaz Jundishapur University of Medical Science
Full name of responsible person
Seyed Behzad Makhmalzadeh
Street address
Ahvaz Jundishapur University of Sciences
City
Ahvaz
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Ahvaz Jundishapur University of Medical Science
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
Ahvaz Jundishapur University of Medical Sciences
Full name of responsible person
Seyed Hamid Borsi
Position
Assistant professor
Other areas of specialty/work
Street address
Pulmonary ward, Internal medicine, Imam Khomeini hospital, Ahvaz, Iran
City
Ahvaz
Postal code
Phone
+61 3 2216 5012
Fax
Email
seyedhamidborsi@yahoo.com
Web page address

Person responsible for scientific inquiries

Contact
Name of organization / entity
Ahvaz Jundishapur University of Medical Sciences
Full name of responsible person
Hanieh Raji
Position
Assistant professor
Other areas of specialty/work
Street address
Internal medicine, Imam Khomeini hospital, Ahvaz, Iran
City
Ahvaz
Postal code
Iran
Phone
+61 3 2216 5012
Fax
Email
dr.raji.h@gmail.com
Web page address

Person responsible for updating data

Contact
Name of organization / entity
Ahvaz Jundishapur University of Medical Sciences
Full name of responsible person
Seyed Hamid Borsi
Position
Assistant Professor
Other areas of specialty/work
Street address
Internal medicine, Imam Khomeini hospital, Ahvaz, Iran
City
Ahvaz
Postal code
Phone
+61 3 2216 5012
Fax
Email
seyedhamidborsi@yahoo.com
Web page address

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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