The aim of this study is to evaluate the effect of body acupancture on Fasting Blood Glucose and Fasting Insulin levels in obese and overweight and then compare the effectiveness of real and sham acupancture on anthropometric. The subjects study were 80 person. Inclusion criteria: Subject should be obese and overweight ؛ men and women؛ aged 18-70 years and Body Mass Index over than 25. Exclusion criteria: lack of treatments of obesity with diet and acupancture in the past 2 weeks؛ lack of diabetes؛ thyroid or adrenal dysfunction. Patients received diet for a week. They were randomly assigned to 2 group. Then Acupancture was started in 8th day of diet and performed 3 sessions per week for 4 weeks. Fasting blood glucose and insulin and anthropometric indices were measured before and after the intervention. Also,glucose levels before and after the third,sixth and ninth sessions of acupancture were measured.
General information
Acronym
IRCT registration information
IRCT registration number:IRCT2016011125967N1
Registration date:2016-10-28, 1395/08/07
Registration timing:retrospective
Last update:
Update count:0
Registration date
2016-10-28, 1395/08/07
Registrant information
Name
Fahime Vafisani
Name of organization / entity
Ferdosi University
Country
Phone
Email address
fahimevafisani@yahoo.com
Recruitment status
Recruitment complete
Funding source
Deputy for Research Mashhad University of Medical Sciences
Expected recruitment start date
2015-05-23, 1394/03/02
Expected recruitment end date
2015-12-11, 1394/09/20
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Effects of Body Acupancture in Compared with Sham Acupancture on Blood Glucose in Overweight and Obese Patients
Public title
Effects of Acupancture on Blood Glucose in Overweight and Obese Patients
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion Criteria: aged 18-70 years؛ Body Mass Index over than 25 and participation in the study and cooperation in blood test.
Exclusion Criteria: lack of treatments of obesity with diet and acupancture in the past 2 weeks؛ lack of diabetes؛ thyroid and adrenal dysfunction and coagulation disorders.
Age
From 18 years old to 70 years old
Gender
Both
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)
Single blinded
Blinding description
Placebo
Not used
Assignment
Parallel
Other design features
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Deputy for Research Mashhad University of Medical Sciences
Street address
Ghoreshi Building, In front of the 18th Daneshgah Avenue, Daneshgah Street
City
Mashhad
Postal code
Approval date
2013-05-11, 1392/02/21
Ethics committee reference number
IR.MUMS.REC.1392.30
Health conditions studied
1
Description of health condition studied
Overweight and Obesity
ICD-10 code
E66
ICD-10 code description
Obesity due to excess calories
Primary outcomes
1
Description
Fasting Blood Glucose
Timepoint
Before the first session and after 12th session of acupancture
Method of measurement
Laboratory kit
2
Description
Fasting Insulin
Timepoint
Before the first session and after 12th session of acupancture
Method of measurement
Laboratory kit
Secondary outcomes
1
Description
Non-fasting glucose
Timepoint
Before and after the third, sixth and ninth session of acupancture
Method of measurement
Glucometer
2
Description
Waist
Timepoint
Before and after the study and sixth session of acupancture
Method of measurement
Meter inelastic
3
Description
Weight and Fat mass
Timepoint
Before and after the study and sixth session of acupancture
Method of measurement
Bioampedance
4
Description
Body Mass Index
Timepoint
Before and after the study and sixth session of acupancture
Method of measurement
Bioampedance
Intervention groups
1
Description
Patients in main group taking diet for a week the in 8th day, period of acuapancture is started. Befor acuapancture Fasting Blood Glucose and Fasting Insulin tests were done. In acuapancture, needling the points associated with weight loss is done. After the last session again Fasting Blood Glucose and Fasting Insulin tests and measurement of anthropometric index were done.
Category
Other
2
Description
Patients in control group taking diet for a week the in 8th day, period of acuapancture is started. Befor acuapancture Fasting Blood Glucose and Fasting Insulin tests were done. In acuapancture, needling is performed in areas unrelated to weight loss. After the last session again Fasting Blood Glucose and Fasting Insulin tests and measurement of anthropometric index were done.
Category
Other
Recruitment centers
1
Recruitment center
Name of recruitment center
Imam Reza Hospital
Full name of responsible person
Fahime Vafi Sani
Street address
Imam Reza Hospital, Doctora Crossroad, Ebnesina Street
City
Mashhad
2
Recruitment center
Name of recruitment center
Nutrition Clinic of Ghaem Hospital
Full name of responsible person
Fahime Vafi Sani
Street address
Ghaem Hospital, Taghi Abad Square, Ahmad Abad Street
City
Mashhad
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Depty for Research Mashhad University of Medical Sciences
Full name of responsible person
Dr.Mohsen Tafaghodi
Street address
Ghoreshi Building, In front of the 18th Daneshgah Avenue, Daneshgah Street
City
Mashhad
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Depty for Research Mashhad 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
Mashhad University of Medical Sciences
Full name of responsible person
Fahime Vafi Sani
Position
Masters Student of Nutrition
Other areas of specialty/work
Street address
Medical college, Vaki Abad Street
City
Mashhad
Postal code
33333-33333
Phone
+98 51 3729 6971
Fax
+98 51 3729 6971
Email
Fahimevafisani@yahoo.com
Web page address
Person responsible for scientific inquiries
Contact
Name of organization / entity
Mashhad University of Medical Sciences
Full name of responsible person
Fahime Vafi Sani
Position
Masters student of Nutrition
Other areas of specialty/work
Street address
Medical college, Vakil Abad Street
City
Mashhad
Postal code
33333-33333
Phone
+98 51 3729 6971
Fax
+98 51 3729 6971
Email
Fahimevafisani@yahoo.com
Web page address
Person responsible for updating data
Contact
Name of organization / entity
Mashhad University of Medical Sciences
Full name of responsible person
Fahime Vafi Sani
Position
Masters student of Nutrition
Other areas of specialty/work
Street address
Medical college, Vakil Abad Street
City
Mashhad
Postal code
33333-33333
Phone
+98 51 3729 6971
Fax
+98 51 3729 6971
Email
Fahimevafisani@yahoo.com
Web page address
Sharing plan
Deidentified Individual Participant Data Set (IPD)