Assessment of effect of Acarbose and pelacebo on the Anthropometric Indicators and metabolic markers in obese women with metabolic syndrome
Design
30patient with bmi =30 or more than 30 and metabolic syndrome for treatment with Acarbose and 30 patient for treatment with placebo.the patients accidentally divided to 2 groups.
Settings and conduct
People with BMI more than 30 enrolled in this study and give them 300 mg tablet of Acarbose . Before and after intervention we check demographic information and metabolic markers.Then we analyzed data .
Participants/Inclusion and exclusion criteria
Entry requirement to study:people,metabolic syndrome,age between 20_50 ,bm=i 30 or more than 30
Conditions for not admitting to study:chronic disease beside metabolic syndrome,lack of cooperation,lipid lowering drug consumer,Metformin consumer in past year,weight loss or diet in past year
Intervention groups
We give by random acarbose or placebo to two groups of people who participate in study
Main outcome variables
Assessment of the efficacy of Acarbose on wiast circumference،and LDL,Ast,Alt,cholestrol Ecocardiography,..
General information
Reason for update
Acronym
IRCT registration information
IRCT registration number:IRCT20130924014752N5
Registration date:2018-03-05, 1396/12/14
Registration timing:retrospective
Last update:2018-03-05, 1396/12/14
Update count:0
Registration date
2018-03-05, 1396/12/14
Registrant information
Name
Noushin Khalili boroujeni
Name of organization / entity
Isfahan university of medical science
Country
Iran (Islamic Republic of)
Phone
+98 31 1792 2472
Email address
n_khalili@med.mui.ac.ir
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2017-03-01, 1395/12/11
Expected recruitment end date
2018-02-20, 1396/12/01
Actual recruitment start date
2017-03-01, 1395/12/11
Actual recruitment end date
2018-02-20, 1396/12/01
Trial completion date
empty
Scientific title
Assessment of the effect of Acarbose on anthropometric indices and metabolic markers in obese women whit metabolic syndrome
Public title
Acarbose effect in metabolic syndrome
Purpose
Prevention
Inclusion/Exclusion criteria
Inclusion criteria:
BMI=30 or more than 30
Affected by metabolic syndrome
Female
Age between 20_50 years
Exclusion criteria:
Chronic disease beside metabolic syndrome
Non cooperative
Consuming anti Lipid drugs
Consuming Metformin in past year
Weight loss or diet in past year
Age
From 20 years old to 50 years old
Gender
Female
Phase
3
Groups that have been masked
Participant
Investigator
Outcome assessor
Sample size
Target sample size:
80
Actual sample size reached:
78
Randomization (investigator's opinion)
Randomized
Randomization description
People who
Blinding (investigator's opinion)
Double blinded
Blinding description
One of our colleagues is selected to attach a blue or green tag on drug or placebo boxes.Only two people know about the meaning of color .If participant has any adverse ,they refer to this colleague who knows about placebo or drug administration and he decide to continue or finish study.
Placebo
Used
Assignment
Parallel
Other design features
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Ethics committee of Isfahan University of Medical sciences
Street address
HezarJerib Street
City
Isfahan
Province
Isfehan
Postal code
8174673461
Approval date
2016-11-22, 1395/09/02
Ethics committee reference number
IR.MUI.REC.1395.4.060
Health conditions studied
1
Description of health condition studied
Obesity
ICD-10 code
E66
ICD-10 code description
Overweight and obesity
Primary outcomes
1
Description
Body weight
Timepoint
At the first visit and each two weeks after three month of consumption of total dose of drug or dose of patient tolerance.
Method of measurement
Body weight scales
2
Description
Height
Timepoint
At first visit and last visit
Method of measurement
Height gauge
3
Description
waist
Timepoint
At first visit and last visit
Method of measurement
Strip meter
4
Description
fasting blood suger
Timepoint
At first visit and end of study
Method of measurement
Enzymatic lab study
5
Description
insulin level of serum
Timepoint
At first visit and end of study
Method of measurement
ELISA method
6
Description
Epicardial fat thickness
Timepoint
At first visit and end of study
Method of measurement
Echocardiography
7
Description
Body Mass Index (BMI)
Timepoint
At first visit and end of study
Method of measurement
BMI = kg/m2 person's weight in kilograms and m2 is their height in metres squared
Secondary outcomes
1
Description
flatulence
Timepoint
Each two weeks
Method of measurement
Questioner
Intervention groups
1
Description
Intervention group: acarbose is administrated for three month with 300 mg .At first it is prescribed with low dose 25 mg three times a day,and gradually placebo dose is increased till 100 mg for each meal.
Category
Treatment - Drugs
2
Description
Control group:placebo is administrated for three month with 300 mg daily .the dose of placebo is increased gradually from 25 mg to 100mg three times for each meal .
Category
Placebo
Recruitment centers
1
Recruitment center
Name of recruitment center
Endocrine Research Center of Isfahan University of Medical Science
Full name of responsible person
Dr Noushin Khalili
Street address
Khoram Street
City
Isfahan
Province
Isfehan
Postal code
8187698191
Phone
+98 31 3335 9090
Email
n_khalili@med.mui.ac.ir
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Endocine Research Center of Isfahan University of Medical Science
Full name of responsible person
Dr Ashraf Aminoroaya
Street address
KHORAM STREET
City
ISFAHAN
Province
Isfehan
Postal code
8187698191
Phone
+98 31 3355 9090
Email
n_khalili@med.mui.ac.ir
Web page address
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Endocine Research Center of Isfahan University of Medical Science
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
Esfahan University of Medical Sciences
Full name of responsible person
Dr Noushin Khalili
Position
Assistante Professor
Latest degree
Subspecialist
Other areas of specialty/work
Internal Medicine
Street address
Khoram Street
City
Isfahan
Province
Isfehan
Postal code
8187698191
Phone
+98 31 3335 9090
Email
n_khalili@med.mui.ac.ir
Person responsible for scientific inquiries
Contact
Name of organization / entity
Esfahan University of Medical Sciences
Full name of responsible person
Khalili Noushin
Position
Assisstant Professor
Latest degree
Subspecialist
Other areas of specialty/work
Internal Medicine
Street address
Khoram Street
City
Isfahan
Province
Isfehan
Postal code
8187698191
Phone
+98 31 3335 9090
Email
n_khalili@med.mui.ac.ir
Person responsible for updating data
Contact
Name of organization / entity
Esfahan University of Medical Sciences
Full name of responsible person
Khalili Noushin
Position
Assistant professor
Latest degree
Subspecialist
Other areas of specialty/work
Internal Medicine
Street address
Khoram Street
City
isfahan
Province
Isfehan
Postal code
8187698191
Phone
+98 31 3335 9090
Email
n_khalili@med.mui.ac.ir
Sharing plan
Deidentified Individual Participant Data Set (IPD)
Yes - There is a plan to make this available
Study Protocol
Yes - There is a plan to make this available
Statistical Analysis Plan
Yes - There is a plan to make this available
Informed Consent Form
Yes - There is a plan to make this available
Clinical Study Report
Yes - There is a plan to make this available
Analytic Code
Yes - There is a plan to make this available
Data Dictionary
Yes - There is a plan to make this available
Title and more details about the data/document
we will publish all kind of information about our study
When the data will become available and for how long
after published it is available for all to get it
To whom data/document is available
researcher and academic people and people who enrolled in study
Under which criteria data/document could be used
for improvement of health care and treatment
From where data/document is obtainable
we will publish it in academic journal then others can use it
What processes are involved for a request to access data/document