The effect of High-intensity interval circuit functional training on Insulin resistance, hemoglobin A1c, body fat percent, and weight loss in diabetes type 2 need to be scrutinized in more detail.
Design
The clinical trial will be conducted on women with type 2 diabetes ranging from 45 to 55 years old. The participants will be randomised into intervention groups and a parallel control group by using "flip the coin" method.
Settings and conduct
pre and post-intervention anthropometric data and blood samples will be collected. The intervention program will last for 10 weeks and 3 sessions per week. Each session includes about 10 minutes of warm-up, about 25 to 30 minutes of main workout, and 5 to 10 minutes of cool down.
Participants/Inclusion and exclusion criteria
in this study, working women with type 2 diabetes aging from 45 to 55 will take part. people with fasting blood sugar over 120, with a sedentary lifestyle, and without any chronic disease history will meet the inclusion criteria.
Intervention groups
The program for the intervention group will be High-intensity interval circuit functional training that will be held for 10 weeks and 3 sessions per week and include bodyweight exercises. The control group will not receive any intervention.
Main outcome variables
insulin resistance and hemoglobin a1c ؛
General information
Reason for update
Acronym
IRCT registration information
IRCT registration number:IRCT20160103025828N1
Registration date:2021-05-31, 1400/03/10
Registration timing:registered_while_recruiting
Last update:2021-05-31, 1400/03/10
Update count:0
Registration date
2021-05-31, 1400/03/10
Registrant information
Name
Rahman Soori
Name of organization / entity
University of Tehran
Country
Iran (Islamic Republic of)
Phone
+98 21 6111 8844
Email address
soori@ut.ac.ir
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2021-05-22, 1400/03/01
Expected recruitment end date
2021-06-22, 1400/04/01
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
The Effect of 10 Weeks High‐Intensity Interval Functional Circuit Training on Insulin Resistance and HbA1C in type 2 diabetes women
Public title
Effect of HIIT in type 2 diabetes
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria:
Fasting blood sugar should be over 120
Being a non-athlete
diabetic women that are overweight
diabetic women that are non-smoker
diabetic women that do not drink alcohol
Exclusion criteria:
diabetic women that are suffering from cardiovascular disease
diabetic women that are suffering from orthopedic problems
diabetic women that are suffering from liver problems
diabetic women that are suffering from nouropatic problems
Age
From 45 years old to 55 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
30 women with type 2 diabetes will take part in this study. Their age will range from 45 to 55 years old. This selection was based on a randomized convenience sampling procedure because of the ease of their volunteering, convenient accessibility. All the participants will get familiar with the process. their anthropometric data and blood samples will be collected. The qualified participants will be assigned into two groups randomly by using "flip the coin" method.
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
ethics committee of Tehran University of Medical Sciences
Street address
Faculty of Physical Education and Sport Sciences, University of Tehran, North Kargar Ave., Tehran, Iran
City
Tehran
Province
Tehran
Postal code
۱۴۱۵۵۶۶۱۹
Approval date
2021-02-23, 1399/12/05
Ethics committee reference number
IR.TUMS.FNM.REC.1400.001
Health conditions studied
1
Description of health condition studied
diabetes type 2
ICD-10 code
ICD-10 code description
Primary outcomes
1
Description
Hba1c in women with type 2 diabetes
Timepoint
Measuring Hba1c 24 hours before intervention and 48 to 72 hours after intervention.
Method of measurement
Hba1c blood test
2
Description
Insulin resistance in women with type 2 diabetes
Timepoint
Measuring insulin resistance 24 hours before intervention and 48 to 72 hours after intervention
Method of measurement
measuring insulin resistance by blood test
Secondary outcomes
1
Description
Body fat percent
Timepoint
Measuring body fat percent pre - and post-intervention
Method of measurement
using body composition analyzer scale and caliper
2
Description
Vo2max
Timepoint
pre- and post intervention
Method of measurement
Rockport test
Intervention groups
1
Description
Intervention group: 15 women with diabetes type 2 will be allocated to circuit HIIT group. circuit HIIT will be conducted 3 sessions per week and includes high intensity interval body weight functional movements such as push up, squat, lunge, plank, etc.
Category
Treatment - Other
2
Description
Control group: 15 women with diabetes type 2 will be allocated to control group. This group will not receive any intervention.
Category
Other
Recruitment centers
1
Recruitment center
Name of recruitment center
diabetes and metabolic syndrome clinic
Full name of responsible person
کاملیا رامبد
Street address
No 10, Jalale Al Ahmad St., Next to Dr. Shariati Hospital Complex, Tehran, Iran