The effect of reduce appetite acupuncture on fasting blood sugar and insulin in pre-diabetic patients compared to the control group
Design
A controlled, parallel-group, single-blind, randomized, phase 3 clinical trial on 102 patients. A random block method was used for randomization
Settings and conduct
102 female patients aged 20-60 referred to the diabetes control clinics of Mazandaran University of Medical Sciences, who were diagnosed with pre-diabetes according to the criteria of ADA2023 by the doctor, after filling out the consent form. The participants in the research project are trained in lifestyle and nutrition counseling and their demographic information and fasting blood sugar tests and insulin levels are recorded. location: sports medicine clinic
Participants/Inclusion and exclusion criteria
Inclusion criteria :Women aged 20-60 with pre-diabetes. Have consent to participate in the study. BMI>=25. Suffer from convulsions, allergies to metals, blood coagulation diseases, various cancers, infectious and skin diseases, and do not have a heart pacemaker. Not pregnant or lactating. Do not undergo drug, hormonal and herbal treatment for blood sugar control. There is no other endocrine disorder disrupting blood sugar control according to the diagnosis of an endocrinologist (including Cushing's disease, etc.). Do not use corticosteroids. Exit criteria: Announcing withdrawal from continuing to participate in the plan. Absence of acupuncture sessions for more than two sessions. Emergence of acupuncture contraindications during the
Intervention groups
Compliance with lifestyle and nutrition recommendations for 8 weeks+ acupuncture at 10 acupuncture points - 2 sessions per week - with an interval of 48 hours - by acupuncture needles with a size of 0.25 x 25 - for 20 minutes in each session
Main outcome variables
Fasting blood sugar and insulin
General information
Reason for update
Acronym
IRCT registration information
IRCT registration number:IRCT20230723058893N1
Registration date:2023-12-14, 1402/09/23
Registration timing:registered_while_recruiting
Last update:2023-12-14, 1402/09/23
Update count:0
Registration date
2023-12-14, 1402/09/23
Registrant information
Name
Sahar Bagheri
Name of organization / entity
Country
Iran (Islamic Republic of)
Phone
+98 11 3336 6552
Email address
dr_sbagheri@yahoo.com
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2023-08-02, 1402/05/11
Expected recruitment end date
2024-06-22, 1403/04/02
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
effectiveness of acupuncture on blood sugar and insulin in women with pre-diabetes
Public title
effectiveness of acupuncture on blood sugar and insulin in women with pre-diabetes
Purpose
Prevention
Inclusion/Exclusion criteria
Inclusion criteria:
1. Women aged 20-60 with pre-diabetes
Diagnosis according to ADA2023 criteria and given by the attending physician and have received the necessary lifestyle and nutritional recommendations
3. Have consent to participate in the study
4. BMI>=25
5. Not suffering from convulsions, allergies to metals, blood coagulation diseases, various cancers, infectious and skin diseases, and not having a heart pacemaker
6. Not pregnant or lactating
7. Do not undergo drug, hormonal and herbal treatment for blood sugar control
8. There is no other endocrine disorder disrupting blood sugar control according to the diagnosis of an endocrinologist (including Cushing's disease, etc.)
9. Do not use corticosteroids
Exclusion criteria:
Age
From 20 years old to 60 years old
Gender
Female
Phase
3
Groups that have been masked
Data analyser
Sample size
Target sample size:
102
Randomization (investigator's opinion)
Randomized
Randomization description
Random block method is used to control the unknown intervening variables. In addition to controlling the intervening variables, if the study is not continued due to unknown problems, the groups included in the study are almost equal, to do this, blocks of 4 will be used and randomly. Randomization will also be done by Random allocate software as follows. This randomization is based on the order of patients entering the clinic.
Blinding (investigator's opinion)
Single blinded
Blinding description
In this plan, the statisticians are only blind, and according to the coding of the patients, they are not aware of the name of the patient group, and the group is determined according to the protocol of random codes in the table
Placebo
Not used
Assignment
Parallel
Other design features
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Committee of Imam Khomeini Hospital in Sari
Street address
Amir Mazandarani Boulevard, Imam Khomeini Hospital
City
Sari
Province
Mazandaran
Postal code
4816633131
Approval date
2023-03-13, 1401/12/22
Ethics committee reference number
IR.MAZUMS.IMAMHOSPITAL.REC.1402.17282
Health conditions studied
1
Description of health condition studied
prediabete
ICD-10 code
ICD-10 code description
Primary outcomes
1
Description
fasting blood sugar & insulin
Timepoint
week 0 and 8
Method of measurement
serum level
Secondary outcomes
1
Description
Anthropometric measures
Timepoint
week 0 and 8
Method of measurement
Body analyzer
Intervention groups
1
Description
Intervention group:Compliance with lifestyle and nutrition recommendations for 8 weeks, in addition, acupuncture at 10 acupuncture points - 2 sessions per week - with an interval of 48 hours (16 sessions in total) - by acupuncture needles with a size of 0.25 x 25 with a depth of 1 centimeters in non-ear areas and gently - for 20 minutes in each session and under sterile conditions with alcohol cotton - by a trained assistant in points Stomach point-(Ren 6) Guanyuan- Liangmen (St 21)- Tianshu (St 25)- Zusanli (St 36)- CV-12 (Zhongwan
Category
Treatment - Devices
2
Description
Control group: Compliance with lifestyle and nutrition recommendations for 8 weeks
Category
Lifestyle
Recruitment centers
1
Recruitment center
Name of recruitment center
Sports medicine clinic
Full name of responsible person
Sahar Bagheri
Street address
Razi 3
City
Sari
Province
Mazandaran
Postal code
4816868890
Phone
+98 11 3336 6552
Email
dr_sbagheri@yahoo.com
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Mazandaran University of Medical Sciences
Full name of responsible person
Pedram Ebrahimnejad
Street address
Moalem Square
City
sari
Province
Mazandaran
Postal code
۴۸۱۵۷۳۳۹۷۱
Phone
+98 11 3325 7230
Email
pajhooheshi@mazums.ac.ir
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Mazandaran University of Medical Sciences
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
Mazandaran University of Medical Sciences
Full name of responsible person
Sahar Bagheri
Position
Assistant Professor
Latest degree
Specialist
Other areas of specialty/work
Sport Medicine
Street address
razi 3
City
sari
Province
Mazandaran
Postal code
486868890
Phone
+98 11 3336 6552
Email
dr_sbagheri@yahoo.com
Person responsible for scientific inquiries
Contact
Name of organization / entity
Mazandaran University of Medical Sciences
Full name of responsible person
Sahar Bagheri
Position
Assistant professor
Latest degree
Specialist
Other areas of specialty/work
Sport Medicine
Street address
Razi 3 - Mostafavian clinic- sport medicine clinic
City
Sari
Province
Mazandaran
Postal code
4816868890
Phone
+98 11 3336 6552
Fax
Email
dr_sbagheri@yahoo.com
Person responsible for updating data
Contact
Name of organization / entity
Mazandaran University of Medical Sciences
Full name of responsible person
Sahar Bagheri
Position
Assistant professor
Latest degree
Specialist
Other areas of specialty/work
Sport Medicine
Street address
Razi 3 - Mostafavian clinic- sport medicine clinic
City
Sari
Province
Mazandaran
Postal code
4816868890
Phone
+98 11 3336 6552
Fax
Email
dr_sbagheri@yahoo.com
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
Not applicable
Title and more details about the data/document
The final Excel file
When the data will become available and for how long
2025
To whom data/document is available
Medical researchers
Under which criteria data/document could be used
By observing ethics in research
From where data/document is obtainable
direct email
What processes are involved for a request to access data/document