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effects of acarbose in metabolic control of patients with diabetes mellitus

Protocol summary

Summary
Introduction:Acarbose is an intestinal alphaglucosidase inhibitor that delays absorption of carbohydrates,the aim of this study was to investigate the effect of administration of acarbose on glycemic & lipid parameters & daily insulin requirements & its tolerance in type 1 diabetic patients. Methods:This was a randomized double blind placebo controlled study, Entry criteria :type 1 diabetes, at least from 1years before & HbA1C ≥7.5% ,exclude criteria: Cr ≥ 2 , partial GI obstruction,IBD .45 patients were randomized to acarbose or placebo for 12 weeks; dosing of acarbose was 25 mg t.d.s for 2 weeks & then 50 mg for 10 weeks .

General information

Acronym
IRCT registration information
IRCT registration number: IRCT201102165844N1
Registration date: 2011-04-17, 1390/01/28
Registration timing: retrospective

Last update:
Update count: 0
Registration date
2011-04-17, 1390/01/28
Registrant information
Name
Shiva Shahnazari
Name of organization / entity
Qazvin university of medical science
Country
Iran (Islamic Republic of)
Phone
+98 28 1336 0084
Email address
shivashahnazari@qums.ac.ir
Recruitment status
Recruitment complete
Funding source
vice- cancellor of Qazvin medical science university
Expected recruitment start date
2010-08-23, 1389/06/01
Expected recruitment end date
2011-01-21, 1389/11/01
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
effects of acarbose in metabolic control of patients with diabetes mellitus
Public title
effects of Acarbose on type 1 diabetes mellitus
Purpose
Treatment
Inclusion/Exclusion criteria
inclusion criteria :type 1 diabetes, at least from 1years before & HbA1C ≥7.5% ,exclusion criteria: Cr ≥ 2 , partial GI obstruction,IBD .
Age
To 30 years old
Gender
Both
Phase
2
Groups that have been masked
No information
Sample size
Target sample size: 45
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
Ethics committee of Qazvin university of medical science
Street address
Qazvin
City
Qazvin
Postal code
Approval date
2010-08-20, 1389/05/29
Ethics committee reference number
28/30/3919

Health conditions studied

1

Description of health condition studied
type 1 diabetes mellitus
ICD-10 code
E10
ICD-10 code description
Insulin-dependent diabetes mellitus

Primary outcomes

1

Description
post prandial glucose
Timepoint
2 hours after each meal
Method of measurement
laboratory kit and Saccharimeter

Secondary outcomes

1

Description
HbA1C
Timepoint
monthly
Method of measurement
laboratory kit

Intervention groups

1

Description
acarbose administration 25 mg TDS 2 weeks then 50mg 10 weeks
Category
Treatment - Drugs

2

Description
placebo administration 25 mg TDS 2 weeks then 50mg 10 weeks
Category
Placebo

Recruitment centers

1

Recruitment center
Name of recruitment center
Clinic Of Endocrine Diseases
Full name of responsible person
Street address
City
Qazvin

Sponsors / Funding sources

1

Sponsor
Name of organization / entity
Deputy for Reaserch of Qazvin University of Medical Science
Full name of responsible person
Dr Saeed Asefzade
Street address
Qazvin
City
Qazvin
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Deputy for Reaserch of Qazvin 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
Qazvin University of Medical Science
Full name of responsible person
Shiva Shahnazari
Position
Resident of Internal ِِِِDiseaes
Other areas of specialty/work
Street address
Qazvin
City
Qazvin
Postal code
Phone
+98 21 8833 5514
Fax
Email
dr.shahnazari.sh@gmail.com
Web page address

Person responsible for scientific inquiries

Contact
Name of organization / entity
Qazvin University of Medical Science
Full name of responsible person
Shiva Shahnazari
Position
Resident of Internal Diseases
Other areas of specialty/work
Street address
Qazvin
City
Qazvin
Postal code
Phone
+98 21 8833 5514
Fax
Email
dr.shahnazari.sh@gmail.com
Web page address

Person responsible for updating data

Contact

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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