40 patients with type 2 diabetes who are eligible for the study were selected and randomly divided into two interventions and placebo groups. Each group was treated for 12 weeks with 40 mg pantaprazole tablets or placebo twice daily. Glucose, hemoglobin A1C, insulin and gastrin levels will be
measured before and after treatment .
General information
Acronym
IRCT registration information
IRCT registration number:IRCT2013070713612N2
Registration date:2013-08-01, 1392/05/10
Registration timing:registered_while_recruiting
Last update:
Update count:0
Registration date
2013-08-01, 1392/05/10
Registrant information
Name
Farzad Najafipour
Name of organization / entity
Tabriz University of Medical Sciences
Country
Iran (Islamic Republic of)
Phone
+98 41 1335 7850
Email address
najafipourf@tbzmed.ac.ir
Recruitment status
Recruitment complete
Funding source
Bone disease health center, Tabriz University of Medical Sciences
Expected recruitment start date
2013-07-23, 1392/05/01
Expected recruitment end date
2014-07-23, 1393/05/01
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Effects of Pantoprazole on serum glucose level in type two diabetic patients
Public title
Effects of Pantoprazole on serum glucose level in type two diabetic patients
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria : type II diabetes and oral blood glucose lowering drugs for at least 5 years; HbA1C level<8.5 percent; willing to participate in the study Exclusion Criteria: Presence of diabetic complications; use of insulin in the week before the study and during the study; pregnancy and lactation
Age
No age limit
Gender
Both
Phase
N/A
Groups that have been masked
No information
Sample size
Target sample size:
40
Randomization (investigator's opinion)
Randomized
Randomization description
Blinding (investigator's opinion)
Double blinded
Blinding description
Placebo
Used
Assignment
Parallel
Other design features
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Tabriz University of Medical Sciences Ethics Committee
Street address
Golgasht street , Tabriz University of Medical Sciences
City
Tabriz
Postal code
Approval date
2013-07-07, 1392/04/16
Ethics committee reference number
9255
Health conditions studied
1
Description of health condition studied
Type 2 diabetes
ICD-10 code
E11
ICD-10 code description
Endocrine, nutritional and metabolic diseases
Primary outcomes
1
Description
Plasma glucose levels
Timepoint
Before and 12 weeks after intervention
Method of measurement
Paraclinical
2
Description
serum gastrtin levels
Timepoint
Before and 12 weeks after intervention
Method of measurement
Paraclinical
3
Description
HbA1C
Timepoint
Before and 12 weeks after intervention
Method of measurement
Paraclinical
4
Description
serum insulin levels
Timepoint
Before and 12 weeks after intervention
Method of measurement
Paraclinical
Secondary outcomes
empty
Intervention groups
1
Description
The intervention group receive 40 mg pantaprazole tablets twice daily for 12 weeks.
Category
Treatment - Drugs
2
Description
The control group receive placebo twice daily for 12 weeks
Category
Placebo
Recruitment centers
1
Recruitment center
Name of recruitment center
Tabriz -Imam Reza hospital
Full name of responsible person
MD farzad najafipour
Street address
Tabriz -Imam Reza hospital
City
tabriz
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Research deputy of Tabriz University of Medical Sciences
Full name of responsible person
Dr. Shakuri Kazem
Street address
Golgasht street , Tabriz University of Medical Sciences
City
Tabriz
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Research deputy of Tabriz University of Medical Sciences
Proportion provided by this source
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
2
Sponsor
Name of organization / entity
Bone disease health center, Tabriz University of Medical Sciences
Full name of responsible person
Dr. Majid Mobaseri
Street address
Iran, Islamic Republic Of
City
tabriz
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Bone disease health center, Tabriz University of Medical Sciences
Proportion provided by this source
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
Tabriz University of Medical Sciences
Full name of responsible person
Dr.Frazad Najafipour
Position
Assistant professor- endocrinologist
Other areas of specialty/work
Street address
Imam Reza hospital- Tabriz
City
Tabriz
Postal code
Phone
+98 41 1335 7850
Fax
Email
Farzad278@yahoo.com
Web page address
Person responsible for scientific inquiries
Contact
Name of organization / entity
Tabriz University of Medical Sciences
Full name of responsible person
Dr. Fazad Najafipour
Position
Associate profeesor- endocrinologist
Other areas of specialty/work
Street address
Imam Reza hospital- Tabriz
City
Tabriz
Postal code
Phone
+98 41 1335 7850
Fax
Email
Farzad278@yahoo.com
Web page address
Person responsible for updating data
Contact
Name of organization / entity
Tabriz University of Medical Sciences
Full name of responsible person
Dr.mohamad hasan omidvar
Position
MD, Resident of Internal Medicine
Other areas of specialty/work
Street address
Imam Reza Hospital, Tabriz Department Of Internal Medicine
City
Tabriz
Postal code
Phone
00
Fax
Email
omidvarmohamad@yahoo.com
Web page address
Sharing plan
Deidentified Individual Participant Data Set (IPD)