Determining the effect of chewing gum on blood sugar control in women with gestational diabetes
Design
In this study, the participants were selected using convenience sampling, and were assigned into the intervention (Chewing gum) and control groups with a ratio of 1:1 by blocked randomization using Random Allocation Software (RAS) with a block size of 4.However, blinding was not possible due to the nature of the treatment modalities in the two groups, so the study used an open-label design.
Settings and conduct
Sampling will be done in an easy way among people from the research community who meet the entry criteria. The sampling location of Rouhani Babol Clinic will be covered by Babol University of Medical Sciences. By using random method with blocks of 4 (ABAB), the study subjects will be divided into two groups, A and B. Due to the intervention methods of the two groups, blinding was not possible and the study is open label and sampling is available.
Participants/Inclusion and exclusion criteria
Pregnant women 18 to 45 years old
Diagnosis of GDM type A1
Between 24 and 27.6 weeks.
Multiple pregnancy
Overt Diabetes in before Pregnancy(such as type 1 or type 2 diabetes)
History of bariatric surgery or malabsorbative bariatric surgery
Chronic infectious diseases like hepatitis
Dysfunction of liver and kidney (before pregnancy)
Personal unwillingness to corporate the research project
Intervention groups
The intervention group will consume one type of sugar-free gum for 20 minutes before each meal for five days.For the control group, no intervention will be done during the research
Main outcome variables
En Changes in fasting blood sugar, one-hour glucose (G1hr) and two-hour glucose (G2hr) and blood sugar after each meal.
General information
Reason for update
Acronym
IRCT registration information
IRCT registration number:IRCT20100510003902N3
Registration date:2023-12-29, 1402/10/08
Registration timing:prospective
Last update:2023-12-29, 1402/10/08
Update count:0
Registration date
2023-12-29, 1402/10/08
Registrant information
Name
Farideh Mohsenzadeh
Name of organization / entity
Babol university of medical sciences
Country
Iran (Islamic Republic of)
Phone
+98 11 1229 8582
Email address
f.mohsenzadeh@mubabol.ac.ir
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2024-01-11, 1402/10/21
Expected recruitment end date
2025-11-12, 1404/08/21
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Effects of gum chewing on glycaemic control in women with gestational diabetes mellitus
Public title
"gum chewing in gestational diabetes mellitus"
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria:
Pregnant women 18 to 45 years old
Diagnosis of GDM type A1
Between 24 and 27.6 weeks.
Exclusion criteria:
Multiple pregnancy
Overt Diabetes in before Pregnancy(such as type 1 or type 2 diabetes)
History of bariatric surgery or malabsorbative bariatric surgery
Chronic infectious diseases like hepatitis
Dysfunction of liver and kidney (before pregnancy)
Personal unwillingness to participate in the research project
Age
From 18 years old to 45 years old
Gender
Female
Phase
N/A
Groups that have been masked
No information
Sample size
Target sample size:
116
Randomization (investigator's opinion)
Randomized
Randomization description
In this study, the participants were selected using convenience sampling, and were assigned into the intervention (Chewing gum) and control groups with a ratio of 1:1 by blocked randomization using Random Allocation Software (RAS) with a block size of 4.
Blinding (investigator's opinion)
Not blinded
Blinding description
Placebo
Not used
Assignment
Parallel
Other design features
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Research ethics committee of Babol University of Medical Sciences
Street address
Mazandaran, Babol, Ganj Afroz Street, Babol University of Medical Sciences
City
Babol
Province
Mazandaran
Postal code
۴۷۱۷۶-۴۷۷۴۵
Approval date
2023-11-27, 1402/09/06
Ethics committee reference number
IR.MUBABOL.REC.1402.135
Health conditions studied
1
Description of health condition studied
Gestational diabetes mellitus in pregnancy
ICD-10 code
O24.41
ICD-10 code description
Gestational diabetes mellitus in pregnancy
2
Description of health condition studied
Gestational Diabetes
ICD-10 code
O24.4
ICD-10 code description
Gestational diabetes mellitus in pregnancy
Primary outcomes
1
Description
Changes in fasting blood sugar, one-hour glucose (G1hr) and two-hour glucose (G2hr) and blood sugar after each meal.
Timepoint
Record fasting blood sugar self-monitoring and one and two hours after each meal for 5 days.
Method of measurement
Glucometer
Secondary outcomes
1
Description
Adverse maternal outcomes (Preterm, pre-eclampsia, shoulder dystocia, low birth weight and macrosomia, Hospitalization in neonatal intensive care unit)
Timepoint
At the end of this study
Method of measurement
Pregnancy outcome questionnaire
Intervention groups
1
Description
Intervention group: The intervention group will consume a type of sugar-free gum for five days for 20 minutes before each meal. Also, the participants are advised to self-monitor fasting blood sugar and one and two hours after Record and report every meal for 5 days.
Category
Treatment - Other
2
Description
Control group: No intervention will be done for the control group during the research. They will receive routine care and standard nutritional counseling. Participants will also be advised to self-monitor their fasting blood sugar and record it one and two hours after each meal for 5 days.
Category
Treatment - Other
Recruitment centers
1
Recruitment center
Name of recruitment center
Ayatollah Rouhani Hospital
Full name of responsible person
Farideh mohsenzadeh Ledari
Street address
Babol University of Medical Sciences, Ganj Afrooz St, Babol, Mazandaran
City
Babol
Province
Mazandaran
Postal code
۴۷۱۷۶۴۷۷۴۵
Phone
+98 11 3219 5323
Email
mohsenzadh2008@gmail.com
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Babol University of Medical Sciences
Full name of responsible person
Mehdi Rajabnia
Street address
Babol University of Medical Sciences, Ganj Afrooz St, Babol, Mazandaran
City
Babol
Province
Mazandaran
Postal code
۴۷۱۷۶۴۷۷۴۵
Phone
+98 11 3219 7667
Email
ramazan69@yahoo.com
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Babol 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
Babol University of Medical Sciences
Full name of responsible person
Farideh Mohsenzadeh Ledari
Position
Assistant Professor of Reproductive Health
Latest degree
Ph.D.
Other areas of specialty/work
Midwifery
Street address
Babol University of Medical Sciences, Ganj Afrooz St, Babol, Mazandaran
City
Babol
Province
Mazandaran
Postal code
۴۷۱۷۶۴۷۷۴۵
Phone
+98 11 3219 5323
Email
mohsenzadeh2008@gmail.com
Person responsible for scientific inquiries
Contact
Name of organization / entity
Babol University of Medical Sciences
Full name of responsible person
Farideh Mohsenzadh Ledari
Position
Assistant Professor of Reproductive Health
Latest degree
Ph.D.
Other areas of specialty/work
Midwifery
Street address
Babol University of Medical Sciences, Ganj Afrooz St, Babol, Mazandaran
City
Babol
Province
Mazandaran
Postal code
۴۷۱۷۶۴۷۷۴۵
Phone
+98 11 3219 5323
Email
mohsenzadh2008@gmail.com
Person responsible for updating data
Contact
Name of organization / entity
Babol University of Medical Sciences
Full name of responsible person
Farideh Mohsenzadh Ledari
Position
Assistant Professor of Reproductive Health
Latest degree
Ph.D.
Other areas of specialty/work
Midwifery
Street address
Babol University of Medical Sciences, Ganj Afrooz St, Babol, Mazandaran
City
Babol
Province
Mazandaran
Postal code
۴۷۱۷۶۴۷۷۴۵
Phone
+98 11 3219 5323
Email
Mohsenzadh2008@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
Undecided - It is not yet known if there will be a plan to make this available
Statistical Analysis Plan
Undecided - It is not yet known if there will be 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
Undecided - It is not yet known if there will be 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