Protocol summary

Summary
This study was performed to examine the effectiveness of body acupuncture on abdominal fat (assessed by Ultrasonography). Our study will be done completely randomized, double blind controlled clinical trial in obese or overweight (BMI: 25-40) in 18 to 65 years old women. The exclusion criteria are: severe or uncontrolled cardiovascular disease, severe or uncontrolled respiratory disease, severe or uncontrolled hematologic disease, severe or uncontrolled kidney disease, severe or uncontrolled neurological disease, patients with complications or severe fearing of needle and who are undergoing bariatric surgery. Sample size for this study is 80 patients. Subjects will receive authentic (cases) or sham (controls) acupuncture for 6 weeks in combination with a low-calorie diet and exercise prescription for weight loss. The participants ask to follow an isocaloric diet for 2 weeks before starting the trial and a low-calorie diet for 6 weeks. The low-calorie diet consisted of 500 kcal deficit per day, less than the individual daily energy expenditure. In the following 12 weeks; they received the low-calorie diet and exercise prescription. Subjects will assess at the beginning, at the end of intervention, 6 and 12 weeks later. For all patients abdominal fat (assess by Ultrasonography), body weight (BW), BMI, and body fat mass, hip circumference (HC), waist circumference (WC), waist hip ratio, biochemical parameters (FBS, ,TG ,HDL ,LDL ,SGOT ,SGPT ,Total cholesterol) and appetite (assess by VAS) will measured.

General information

Acronym
IRCT registration information
IRCT registration number: IRCT201402178588N18
Registration date: 2014-05-03, 1393/02/13
Registration timing: registered_while_recruiting

Last update:
Update count: 0
Registration date
2014-05-03, 1393/02/13
Registrant information
Name
Mohadeseh Pishgahroudsari
Name of organization / entity
Mnimally Invasive Surgery Research Center
Country
Iran (Islamic Republic of)
Phone
+98 21 6655 5447
Email address
research@lapsurg.ir
Recruitment status
Recruitment complete
Funding source
Iran University of Medical Sciences.
Expected recruitment start date
2014-04-21, 1393/02/01
Expected recruitment end date
2016-02-20, 1394/12/01
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Effects of acupuncture on ultrasonography result of abdominal subcutaneous fat in overweight and obese women: double blind, randomized, controlled clinical trial
Public title
Effect of acupuncture on reducing abdominal fat and treatment of obesity
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria: woman,Age :18 to 65 , BMI: 25-40 Exclusion criteria: pregnancy, lactation, severe or uncontrolled endocrine abnormalities, severe or uncontrolled cardiovascular disease, severe or uncontrolled immunologic disease, severe or uncontrolled hematologic disease, They had previously not participated in weight control measures and had no relevant medical or drug history for weight control in the 3 months prior to recruitment, severe complications, severe fearing of needle, bariatric surgery
Age
From 18 years old to 65 years old
Gender
Female
Phase
N/A
Groups that have been masked
No information
Sample size
Target sample size: 80
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
Iran University of Medical Sciences
Street address
Tehran
City
Tehran
Postal code
Approval date
2014-02-22, 1392/12/03
Ethics committee reference number
99888

Health conditions studied

1

Description of health condition studied
Obesity
ICD-10 code
E66
ICD-10 code description
Obesity

Primary outcomes

1

Description
abdominal subcutaneous fat
Timepoint
before intervention, 1 week after intervention, 6 weeks after intervention, 12 weeks after intervention
Method of measurement
ultrasonography

Secondary outcomes

1

Description
Weight
Timepoint
before intervention, 1 week after intervention, 6 weeks after intervention, 12 weeks after intervention
Method of measurement
Scale

2

Description
biochemical parameters
Timepoint
before intervention, 1 week after intervention, 6 weeks after intervention, 12 weeks after intervention
Method of measurement
Diagnostic lab kits

Intervention groups

1

Description
In case group subjects will receive authentic acupuncture for treatment of obesity twice weekly for 6 weeks.
Category
Treatment - Other

2

Description
In control group subjects will receive sham acupuncture twice weekly for 6 weeks.
Category
Treatment - Drugs

Recruitment centers

1

Recruitment center
Name of recruitment center
Rasoul-e-Akram Hospital
Full name of responsible person
Street address
City
Tehran

Sponsors / Funding sources

1

Sponsor
Name of organization / entity
Iran University of Medical Sciences
Full name of responsible person
Dr.Seyed Ali Javad Mousavi
Street address
Iran University of Medical sciences, south side of Hemmat highway, Tehran, Iran.
City
Tehran
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Iran University of Medical Sciences
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
Minimally Invasive Surgery Research Center
Full name of responsible person
Zeinab Karimi
Position
Resident of Sport Medicine
Other areas of specialty/work
Street address
Minimally Invasive Surgery Research Center, Rasool-e-Akram Hospital, Niyayesh Ave, Sattarkhan St., Tehran, Iran.
City
Tehran
Postal code
Phone
+98 21 6435 2446
Fax
Email
dr.zeinabk@yahoo.com
Web page address

Person responsible for scientific inquiries

Contact
Name of organization / entity
Minimally Invasive Surgery Research Center
Full name of responsible person
Ali Mazaherinezhad
Position
Specialist of Sport Medicine
Other areas of specialty/work
Street address
Minimally Invasive Surgery Research Center, Rasool-e-Akram Hospital, Niyayesh Ave, Sattarkhan St., Tehran, Iran.
City
Tehran
Postal code
Phone
+98 21 6435 2446
Fax
Email
mazaherinezhad@gmail.com
Web page address

Person responsible for updating data

Contact
Name of organization / entity
Minimally Invasive Surgery Research Center
Full name of responsible person
Mohadeseh Pishgahroudsari
Position
Other areas of specialty/work
Street address
Minimally Invasive Surgery Research Center, Rasool-e-Akram Hospital, Niyayesh Ave, Sattarkhan St., Tehran, Iran
City
Tehran
Postal code
Phone
+98 21 6435 2145
Fax
Email
mo.pishgah@gmail.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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