Determine the Effects of Vestibular Galvanic Stimulation (GVS) on Blood Glucose Control in Patients with Type 2 Diabetes Mellitus
Design
Clients are selected according to inclusion and exclusion criteria and then we will divide them in two equal groups of 16 people by random blocking method.
The sample size for each group will be 16 people .
Settings and conduct
People with diabetes mellitus referred to Zahedan Diabetes Clinic located at Bou-ali Hospital, Zahedan.
First, each person participating in the study will receive a fasting blood glucose test and hemoglobin A1C baseline. The stimulator was designed using a vestibular galvanic stimulation.
At the beginning of each week, blood sampling will be done by a laboratory technician to check blood sugar levels before and after stimulation. At the end of the 12th week, we will also have a sample to measure blood glucose and hemoglobin A1C. Glucose and hemoglobin A1C of the intervention group is evaluated again one month after the end of the stimulation presentation.
Participants/Inclusion and exclusion criteria
Patients who have been diagnosed with diabetes for at least 6 months and receive the same therapeutic treatment of blood glucose and their hemoglobin A1C is not more than 9.5% .
Intervention groups
Each person receives stimulation three times a week in three different days. Each time the stimulation is set to 20 minutes, its flow is set at the threshold of the individual. The Stochastic Stream uses random frequencies from 1 to 30 Hz.In control group electrodes placed same as other group but the current will be zero.
Main outcome variables
blood glucose level and HbA1c
General information
Reason for update
Acronym
GVS
IRCT registration information
IRCT registration number:IRCT20180228038904N1
Registration date:2018-06-30, 1397/04/09
Registration timing:retrospective
Last update:2018-06-30, 1397/04/09
Update count:0
Registration date
2018-06-30, 1397/04/09
Registrant information
Name
Aghil Absalan
Name of organization / entity
Country
Iran (Islamic Republic of)
Phone
+98 21 2243 6092
Email address
aghilabsalan@zaums.ac.ir
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2018-04-21, 1397/02/01
Expected recruitment end date
2018-06-22, 1397/04/01
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Effect of galvanic vestibular stimulation on reduction of blood glucose level and HbA1c of type 2 diabetic patients
Public title
Effect of galvanic vestibular stimulation on diabetes
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria:
Confirmation of Type 2 Diabetes Mellitus by Endocrinologist
Patients who have been diagnosed with diabetes for at least 6 months and receive Metformin
The hemoglobin A1C is between 7.5 and 9.5%
Collaboration on the exam
Exclusion criteria:
Having digestive and balance disorders
Having systemic diseases
use of non-diabetic drugs that affect blood glucose
Age
No age limit
Gender
Both
Phase
N/A
Groups that have been masked
Participant
Sample size
Target sample size:
48
Randomization (investigator's opinion)
Randomized
Randomization description
They are selected according to inclusion and exclusion criteria and then we will divide them in two equal groups of 16 people by random blocking method. The control group will receive the false stimulus or sham and the intervention group will receive the GVS.
In this method, control group and intervention group named as A and B respectively. Six statuses (AABB, ABAB, ABBA, BBAA, BABA, and BAAB) are written on paper and in the first stage one of them will be selected randomly. Four first patients will be grouped according to selected status. This trend continues 8 times
Blinding (investigator's opinion)
Single blinded
Blinding description
The control group receiving the false stimulus or sham and the intervention group receiving the GVS are not aware about receiving true stimulation.
Placebo
Used
Assignment
Parallel
Other design features
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Ethics committee of University of Social Welfare and Rehabilitation Sciences
Street address
Velenjak, Daneshjoo Blvd, Koodakyar ave.
City
Tehran
Province
Tehran
Postal code
۱۹۸۵۷۱۳۸۳۴
Approval date
2017-11-11, 1396/08/20
Ethics committee reference number
IR.USWR.REC.1396.249
Health conditions studied
1
Description of health condition studied
Type 2 diabetes
ICD-10 code
E08
ICD-10 code description
Diabetes mellitus due to underlying condition
Primary outcomes
1
Description
Blood glucose level
Timepoint
Blood glucose at beginning of study,first day of every week, last day of 12th week,one month after the end of stimulation.nd of stimulation.
Method of measurement
blood sampling by the laboratory
2
Description
HbA1C
Timepoint
HbA1C at beginning of study,last day of 12th week,one month after the end of stimulation.
Method of measurement
blood sampling by the laboratory
Secondary outcomes
empty
Intervention groups
1
Description
Intervention group: Each person receives galvanic vestibular stimulation three times a week in three different days. Each time the stimulation is set to 20 minutes, its flow is set at the threshold of the individual. The Stochastic Stream uses random frequencies from 1 to 30 Hz.
Category
Treatment - Other
2
Description
Control group (Sham): Each person receives galvanic vestibular stimulation three times a week in three different days. Each time the stimulation is set to 20 minutes . The current is ziro
Category
Treatment - Other
Recruitment centers
1
Recruitment center
Name of recruitment center
Diabetes center,Bu-Ali hospital,Zahedan
Full name of responsible person
Dr. MahmmodAli Keykhaei
Street address
Amiralmomenin Ave
City
zahedan
Province
Sistan-va-Balouchestan
Postal code
9813617697
Phone
+98 54 3322 8101
Email
mazyar44@gmail.com
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
University of social welfare and rehabilitation sciences
Full name of responsible person
Dr.Amir Masoud Arab Loodaricheh
Street address
University of Social Welfare and Rehabilitation Sciences,Koodakyar Ave,Daneshjoo Blvd,Velenjak
City
Tehran
Province
Tehran
Postal code
۱۹۸۵۷۱۳۸۳۴
Phone
+98 21 2218 0083
Fax
+98 21 2218 0109
Email
am.arabloo@uswr.ac.ir
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
University of social welfare and rehabilitation 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
University of social welfare and rehabilitation sciences
Full name of responsible person
Dr. Younes Lotfi
Position
Associate Professor
Latest degree
Specialist
Other areas of specialty/work
Ear, Nose, and Throat
Street address
Audiology department,University of Social Welfare and Rehabilitation Sciences,Koodakyar ave,daneshjoo blvd,velenjak
City
Tehran
Province
Tehran
Postal code
۱۹۸۵۷۱۳۸۳۴
Phone
+98 21 2218 0083
Email
yones1333@gmail.com
Person responsible for scientific inquiries
Contact
Name of organization / entity
University of social welfare and rehabilitation sciences
Full name of responsible person
Aghil Absalan
Position
دانشجو دکتری
Latest degree
Master
Other areas of specialty/work
Audiology
Street address
Audiology department,zahedan university of medical sciences
City
Zahedan
Province
Sistan-va-Balouchestan
Postal code
9816743463
Phone
+98 54 3343 9916
Email
aghilabsalan@zaums.ac.ir
Person responsible for updating data
Contact
Name of organization / entity
University of social welfare and rehabilitation sciences
Full name of responsible person
Aghil Absalan
Position
دانشجو دکتری
Latest degree
Master
Other areas of specialty/work
Audiology
Street address
Audiology department,Zahedan university of medical sciences
City
Zahedan
Province
Sistan-va-Balouchestan
Postal code
9816743463
Phone
+98 54 3343 9916
Email
aghilabsalan@zaums.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
Undecided - It is not yet known if there will be a plan to make this available
Clinical Study Report
Yes - There is a plan to make this available
Analytic Code
Undecided - It is not yet known if there will be a plan to make this available
Data Dictionary
Undecided - It is not yet known if there will be a plan to make this available
Title and more details about the data/document
Individual data after being unidentifiable
When the data will become available and for how long
after publication
To whom data/document is available
researchers
Under which criteria data/document could be used
It is only allowed to mention the results
From where data/document is obtainable
aghil absalan
aghilabsalan@zaums.ac.ir
What processes are involved for a request to access data/document