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The effect of type of pre-exercise breakfast on postprandial glycemic indices in women with type 2 diabetes

Protocol summary

Study aim
Investigating the effect of fasting and the type of breakfast before exercise on the index of the area under the glucose curve after a meal (Glucose AUC) and glucose levels 2 hours after a meal in women with type 2 diabetes
Design
Clinical trial with crossover groups, unblinded, randomized, on 12 patients ,Simple randomization
Settings and conduct
This research is of a semi-experimental and cross-over type, in which the subjects will randomly perform one of the following 4 interventions with an interval of one week:1- Exercise while fasting,2- Exercise after consuming a standard breakfast ,3- Exercise after consuming breakfast with high carbohydrates and low protein ,4- Exercise after Eating breakfast with high protein and low carbohydrates. In the first intervention, people will perform the specified exercise in fasting state and 10 minutes later, a glucose tolerance test will be taken. In the second, third, and fourth interventions, the subjects will perform exercise 90 minutes after consuming the indicated breakfast, and a glucose tolerance test will be taken 10 minutes after the exercise.
Participants/Inclusion and exclusion criteria
Inclusion criteria: having type 2 diabetes, being allowed to engage in physical activity, not having a history of regular sports activity, no change in diet and medication. Exclusion criteria: suffering from knee osteoarthritis, use of insulin in the treatment process, suffering from cardiovascular disease, male gender
Intervention groups
1: performing sports activities while fasting 2: Doing sports activities after eating a standard breakfast 3: doing sports activities after eating breakfast with high protein 4: doing sports activities after consuming breakfast with high carbohydrates
Main outcome variables
Index of the area under the glucose curve after a meal (AUC Glucose); Glucose levels 2 hours after a meal

General information

Reason for update
Acronym
IRCT registration information
IRCT registration number: IRCT20231108060000N1
Registration date: 2023-12-29, 1402/10/08
Registration timing: registered_while_recruiting

Last update: 2023-12-29, 1402/10/08
Update count: 0
Registration date
2023-12-29, 1402/10/08
Registrant information
Name
Mona Emandost
Name of organization / entity
The university of kashan
Country
Iran (Islamic Republic of)
Phone
+98 31 5557 0700
Email address
monaimandust@gmail.com
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2023-12-27, 1402/10/06
Expected recruitment end date
2024-01-15, 1402/10/25
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
The effect of type of pre-exercise breakfast on postprandial glycemic indices in women with type 2 diabetes
Public title
The effect of fasting and the type of pre-exercise on diabetes
Purpose
Prevention
Inclusion/Exclusion criteria
Inclusion criteria:
At least six months have passed since the diagnosis of type 2 diabetes by the relevant doctor not changing the diet and medication not having a history of exercising regularly being allowed to exercise
Exclusion criteria:
Having knee osteoarthritis Having cardiovascular disease Male gender Using insulin in the treatment process
Age
From 30 years old to 65 years old
Gender
Female
Phase
N/A
Groups that have been masked
No information
Sample size
Target sample size: 12
Randomization (investigator's opinion)
Randomized
Randomization description
The subjects included in the current research will implement one of the four interventions in a cross-over manner with a random design. To randomize the interventions, the method of simple randomization using sealed envelopes will be used. Also, the person who will group the interventions will be blinded to the type of intervention.
Blinding (investigator's opinion)
Not blinded
Blinding description
Placebo
Not used
Assignment
Crossover
Other design features

Secondary Ids

empty

Ethics committees

1

Ethics committee
Name of ethics committee
Research ethics committees of kashan university
Street address
Sedaghat allry, shahid gholi Ave ,shahid beheshti Ave , kashan Toen
City
Kashan
Province
Isfehan
Postal code
8715145333
Approval date
2023-11-06, 1402/08/15
Ethics committee reference number
IR.KASHANU.REC.1402.041

Health conditions studied

1

Description of health condition studied
Diabetes
ICD-10 code
E11
ICD-10 code description
Type 2 diabetes mellitus

Primary outcomes

1

Description
Blood glucose
Timepoint
15 minutes; 30 minutes; 60 minutes; 90 minutes; 120 minutes after exercise
Method of measurement
Glocometere

Secondary outcomes

empty

Intervention groups

1

Description
Intervention group: People eat a standard breakfast with a certain combination of macronutrients, including 55 grams of carbohydrates, 15 grams of protein, and 30 grams of fat. After one hour, they perform specific exercise and their blood glucose levels are measured at specific time intervals.
Category
N/A

2

Description
Intervention group: People eat breakfast with high carbohydrates including 55 grams of carbohydrates, 22 grams of protein, and 13 grams of fat. After one hour, they perform specific exercise and their blood glucose levels are measured at specific time intervals.
Category
N/A

3

Description
Intervention group: People eat breakfast with high protein including 22 grams of carbohydrates, 55 grams of protein, and 13 grams of fat. After one hour, they perform specific exercise and their blood glucose levels are measured at specific time intervals.
Category
N/A

4

Description
Control group: People perform specific sports training while fasting and their blood glucose levels are measured during specific time intervals.
Category
N/A

Recruitment centers

1

Recruitment center
Name of recruitment center
diabetes association
Full name of responsible person
Mona Emandost
Street address
sedaghat Alley- Gholi ave - Beheshti Ave
City
kashan
Province
Isfehan
Postal code
8715145333
Phone
+98 31 5557 0700
Email
monaimandust@gmail.com

Sponsors / Funding sources

1

Sponsor
Name of organization / entity
Kashan university
Full name of responsible person
Mona Emandost
Street address
Beheshti Ave
City
Kashan
Province
Isfehan
Postal code
8715145333
Phone
+98 31 5557 0700
Email
monaimandust@gmail.com
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Kashan university
Proportion provided by this source
10
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
Kashan university
Full name of responsible person
Mona Emandost
Position
student
Latest degree
Bachelor
Other areas of specialty/work
Physiology
Street address
Beheshti Ave
City
Kashan
Province
Isfehan
Postal code
8715145333
Phone
+98 31 5557 0700
Email
monaimandust@gmail.com

Person responsible for scientific inquiries

Contact
Name of organization / entity
Kashan university
Full name of responsible person
Mona Emandost
Position
student
Latest degree
Bachelor
Other areas of specialty/work
Physiology
Street address
Beheshti Ave
City
Kashan
Province
Isfehan
Postal code
8715145333
Phone
+98 31 5557 0700
Email
monaimandost@gmail.com

Person responsible for updating data

Contact
Name of organization / entity
Kashan university
Full name of responsible person
Mona Emandost
Position
student
Latest degree
Bachelor
Other areas of specialty/work
Physiology
Street address
Beheshti Ave
City
Kashan
Province
Isfehan
Postal code
8715145333
Phone
+98 31 5557 0700
Email
monaimandust@gmail.com

Sharing plan

Deidentified Individual Participant Data Set (IPD)
No - There is not a plan to make this available
Justification/reason for indecision/not sharing IPD
There is no further information
Study Protocol
No - There is not a plan to make this available
Statistical Analysis Plan
No - There is not a plan to make this available
Informed Consent Form
No - There is not a plan to make this available
Clinical Study Report
Not applicable
Analytic Code
Not applicable
Data Dictionary
Not applicable
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