Protocol summary

Study aim
Determining the Effect of Co-Prescribing Orlistat and Acrobats on Weight Control in Obese People
Design
A randomized clinical trial, blind, double blind, controlled clinical trials, and a sample of 90 subjects who had entered the study by simple sampling after obtaining consent, using a balanced block randomization with three blocks in three groups (30 subjects ) Are placed. All three groups of multivitamin tablets (weekly one) to prevent fat-soluble vitamin deficiencies and 40 mg of dimethicone three times a day will improve the symptoms of bleeding from orlistat and daily acarbose for 6 months.
Settings and conduct
1- Calculation of BMI and measurement of FBS, TG, LDL, HDL, cholesterol and insulin before and after intervention. 2- Setting up a diet and training the diet appropriately by a nutrition expert 3- Distribution of drugs and body weight measurement, delivery of supplements and monitoring their use, registration of possible side effects of medication, diet and diet monitoring, and physical activity on the checklist on a monthly basis. The design is done at the Endocrine Research Center of Kerman University of Medical Sciences.
Participants/Inclusion and exclusion criteria
Inclusion criteria: aged 20 to 50 years / non-underlying disease and BMI> 30. Exclusion criteria: Cases of cardiovascular / gastrointestinal / malabsorption / hyperlipidemia or hypothyroidism / Cushing's disease / Previously diagnosed diabetes by a doctor or existing documentation
Intervention groups
1- Orlistat drug group (3 daily food supplements, 180 mg) 2- Orlistat-Acarbose group (60 mg orlistat 3 times a day with food, 25 mg acarbose three times daily at the start of meal) 3- Control group (multivitamin, weekly 1)
Main outcome variables
Age, sex, height, weight, BMI, FBS, LDL, HDL, TG, insulin, waist circumference, hip circumference, WHR

General information

Reason for update
Acronym
IRCT registration information
IRCT registration number: IRCT20090317001774N9
Registration date: 2018-09-19, 1397/06/28
Registration timing: registered_while_recruiting

Last update: 2018-09-19, 1397/06/28
Update count: 0
Registration date
2018-09-19, 1397/06/28
Registrant information
Name
Mojgan Sanjari
Name of organization / entity
Kerman University of Medical Science
Country
Iran (Islamic Republic of)
Phone
+98 34 1322 2506
Email address
msanjari@kmu.ac.ir
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2018-03-21, 1397/01/01
Expected recruitment end date
2019-03-21, 1398/01/01
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Study on the effects of co-administration of lipase inhibitor and Alpha-glucosidase inhibitor in control of weight in obese patient
Public title
Study lipase inhibitor and Alpha-glucosidase inhibitor in control of weight in obese patient
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria:
Age 20 to 50 years Lack of underlying illness BMI>30
Exclusion criteria:
Fasting Blood Glucose Over 250 Hemoglobin A1C higher than 9% Insulin therapy Chronic inflammatory disease Chronic complications of diabetes Pregnancy Lactation Liver Diseases Kidney Diseases Neurological diseases
Age
From 20 years old to 50 years old
Gender
Both
Phase
2-3
Groups that have been masked
  • Data analyser
Sample size
Target sample size: 90
Randomization (investigator's opinion)
Randomized
Randomization description
After obtaining consent, the patients are divided into three groups based on entering the study and the method of balanced block randomization with triple blocks. The first group received orlistat (three daily food supplements, 180 mg), the second group was orlistat-acarbose (orlistat 60 mg three times daily with food, 25 mg acarbose three times daily at the start of meal) and the group Control (multivitamin, weekly 1).
Blinding (investigator's opinion)
Double blinded
Blinding description
The blinding of groups is divided by the expert of the research center which is not involved in the implementation of the plan, and is kept in the dark envelope in the package until the end of the design and final analysis at the research center. According to the traditional use group, there is no possibility of blindness for the physician and the patient. But randomization is done in the form of a balanced block randomization in binary groups and four blocks, and the statistician is blind compared to the groups.
Placebo
Used
Assignment
Parallel
Other design features

Secondary Ids

empty

Ethics committees

1

Ethics committee
Name of ethics committee
Ethics Committee Vice chancellor for Research and Technology of kerman university of medical scienc
Street address
Kerman, Vice chancellor for Research and Technology of University of Medical Sciences, Tahmasb Abad crossroads, the begining of Jahad Boulevard, the begining of Ebn-e-Sina street, In front of Besat clinic
City
kerman
Province
Kerman
Postal code
7619813159
Approval date
2017-03-13, 1395/12/23
Ethics committee reference number
IR.KMU.REC.1395.1001

Health conditions studied

1

Description of health condition studied
ICD-10 code
ICD-10 code description

2

Description of health condition studied
obesity
ICD-10 code
E66
ICD-10 code description
Overweight and obesity

Primary outcomes

1

Description
Blood glucose after 8 hours of fasting
Timepoint
Before intervention and 6 months after intervention
Method of measurement
Spectrophotometer

2

Description
Measuring low density lipoprotein in serum
Timepoint
Before intervention and 6 months after intervention
Method of measurement
Using an auto-analyzer method

3

Description
Measuring high density lipoprotein in serum
Timepoint
Before intervention and 6 months after intervention
Method of measurement
Using an auto-analyzer method

4

Description
Measuring blood cholesterol
Timepoint
Before intervention and 6 months after intervention
Method of measurement
Using an auto-analyzer method

5

Description
Measuring blood triglycerides
Timepoint
Before intervention and 6 months after intervention
Method of measurement
Using an auto-analyzer method

6

Description
Insulin measurement
Timepoint
Before intervention and 6 months after intervention
Method of measurement
Using ELISA test

Secondary outcomes

1

Description
Weight
Timepoint
Before intervention and 6 months after intervention
Method of measurement
Scales

2

Description
Height
Timepoint
Before intervention and 6 months after intervention
Method of measurement
meter

3

Description
Waist
Timepoint
Before intervention and 6 months after intervention
Method of measurement
meter

4

Description
Hip circumference
Timepoint
Before intervention and 6 months after intervention
Method of measurement
meter

5

Description
BMI
Timepoint
Before intervention and 6 months after intervention
Method of measurement
The squared height is divided by weight

6

Description
WHR
Timepoint
Before intervention and 6 months after intervention
Method of measurement
Computing

Intervention groups

1

Description
First Intervention group: The recipient of Orlistat (three daily food supplements, 180 mg) for 6 months
Category
Treatment - Drugs

2

Description
Second Intervention group: The recipient of Orlistat and Acarbose (Orlistate 60mg 3 times daily with food, 25mg acarbose three times daily at the start of meal) for 6 months
Category
Treatment - Drugs

3

Description
Control group: placebo (Multivitamin, weekly 1) for 6 months
Category
Placebo

Recruitment centers

1

Recruitment center
Name of recruitment center
Besat Clinic
Full name of responsible person
Dr. Mojgan Sanjari
Street address
Besat Clinic, Ebne sina Ave, Jahad Blvd, Kerman, Iran
City
kerman
Province
Kerman
Postal code
7616913555
Phone
+98 34 3226 4087
Email
mjnsanjari@gmail.com

Sponsors / Funding sources

1

Sponsor
Name of organization / entity
Kerman University of Medical Sciences
Full name of responsible person
Dr.Abbas Pardakhti
Street address
Deputy of research and technology, Ebne sina Ave, Jahad Blvd, Kerman, Iran
City
kerman
Province
Kerman
Postal code
7616913555
Phone
+98 34 3226 3787
Email
abpardakhty@kmu.ac.ir
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Kerman University of Medical Sciences
Proportion provided by this source
50
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
Qazvin University of Medical Sciences
Full name of responsible person
Dr.Ehsan Aali
Position
Assistant Professor
Latest degree
Ph.D.
Other areas of specialty/work
Medical Pharmacy
Street address
Ghazvin University of Medical Sciences - Shahid Bahonar Blvd. - Qazvin - Iran
City
kerman
Province
Kerman
Postal code
34199-15315
Phone
+98 28333360015
Email
e.aali@qums.ac.ir

Person responsible for scientific inquiries

Contact
Name of organization / entity
Kerman University of Medical Sciences
Full name of responsible person
Dr.Mojgan Sanjari
Position
professor
Latest degree
Subspecialist
Other areas of specialty/work
Endocrinology and Metabolism
Street address
Afzalipour Hospital, Kerman
City
kerman
Province
Kerman
Postal code
7616913911
Phone
+98 34313280003
Email
mjnsanjari@gmail.com

Person responsible for updating data

Contact
Name of organization / entity
Kerman University of Medical Sciences
Full name of responsible person
Dr. Mojgan Sanjari
Position
Professor
Latest degree
Subspecialist
Other areas of specialty/work
Endocrinology and Metabolism
Street address
Afzalipour Hospital, Kerman
City
kerman
Province
Kerman
Postal code
7616913911
Phone
+98 34313280003
Email
mjnsanjari@gmail.com

Sharing plan

Deidentified Individual Participant Data Set (IPD)
Undecided - It is not yet known if there will be a plan to make this available
Study Protocol
No - There is not a plan to make this available
Statistical Analysis Plan
No - There is not a plan to make this available
Informed Consent Form
No - There is not a plan to make this available
Clinical Study Report
No - There is not a plan to make this available
Analytic Code
No - There is not a plan to make this available
Data Dictionary
No - There is not a plan to make this available
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