Comparison of the effect of energy-matched continuous vs high-intensity interval training with weight-loss diet on metabolic indices and arterial stiffness in patients with type-2 diabetes
Comparison of the effect of energy-matched continuous vs high intensity interval training with weight-loss diet on metabolic indices and arterial stiffness in patients with type-2 diabetes
Design
A clinical trial including 2 experimental and a control group with parallel design and without blinding in which participants will be randomly assigned to study groups.
Settings and conduct
This study will be conducted by joint cooperation of Shahrood University of Technology and Shahrood University of Medical Sciences, in which diabetic patients with medical records will participate and receive relevant interventions for 12 weeks.
Participants/Inclusion and exclusion criteria
Inclusion criteria: History of type-2 diabetes over 5 years, glycosylated hemoglobin (Hb1Ac) over 6.5%, fasting blood glucose over 126 mg/dl, inactive lifestyle and body mass index over 25 kg/m2. Exclusion criteria: having weight-loss diet, severe diabetic complications like foot ulcer, not permitted for exercise.
Intervention groups
Experimental group 1, continuous training on treadmill for 12 weeks, 3 session pre week and 36 sessions in total and experimental group 2, interval training on treadmill for 12 weeks, 3 session pre week and 36 sessions in total.
Main outcome variables
Glycosylated hemoglobin (HbA1c); systolic blood pressure; Cardio-ankle vascular index (CAVI); Weight; body fat percentage
General information
Reason for update
Acronym
IRCT registration information
IRCT registration number:IRCT20170120032066N5
Registration date:2023-05-31, 1402/03/10
Registration timing:prospective
Last update:2023-05-31, 1402/03/10
Update count:0
Registration date
2023-05-31, 1402/03/10
Registrant information
Name
Farhad Gholami
Name of organization / entity
Shahrood University of Technology
Country
Iran (Islamic Republic of)
Phone
+98 41332395900
Email address
gholami-fa@shahroodut.ac.ir
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2023-06-20, 1402/03/30
Expected recruitment end date
2023-07-06, 1402/04/15
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Comparison of the effect of energy-matched continuous vs high-intensity interval training with weight-loss diet on metabolic indices and arterial stiffness in patients with type-2 diabetes
Public title
Effect of energy-matched continuous vs interval training in type-2 diabetes
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria:
History of type-2 diabetes over 5 years
Glycosylated hemoglobin (Hb1Ac) over 6.5%
Fasting blood glucose over 126 mg/dl
Inactive lifestyle
Body mass index over 25 kg/m2
Exclusion criteria:
Having weight-loss diet
Severe diabetic complications like foot ulcer
Not permitted for exercise
Age
From 18 years old to 55 years old
Gender
Both
Phase
N/A
Groups that have been masked
No information
Sample size
Target sample size:
58
Randomization (investigator's opinion)
Randomized
Randomization description
Participants will be allocated to continuous exercise, interval exercise and control groups with 1:1:1 ratio. Participants will be classified based on BMI and HbA1c level to ensure inter-group homogeneity and stratified blocked randomization with block size of 4-6 will be applied. Sequencing using table of random numbers will be generated by a blind assistant to ensure allocation concealment.
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 committer of Shahrood University of Technology
Street address
Shahrood University of Technology, 7-Tir Square
City
Shahrood
Province
Semnan
Postal code
3619995161
Approval date
2023-05-13, 1402/02/23
Ethics committee reference number
IR.SHAHROODUT.REC.1402.002
Health conditions studied
1
Description of health condition studied
Type-2 diabetes
ICD-10 code
E11
ICD-10 code description
Type 2 diabetes mellitus
Primary outcomes
1
Description
Glycosylated hemoglobin (HbA1c)
Timepoint
Measurement of glycosylated hemoglobin (HbA1c) before and after 12 weeks intervention
Method of measurement
Using a commercial kit through enzymatic method
2
Description
systolic blood pressure
Timepoint
Measurement of systolic blood pressure before and after 12 weeks intervention
Method of measurement
Digital sphygmomanometer
3
Description
Cardio-ankle vascular index (CAVI)
Timepoint
Measurement of Cardio-ankle vascular index (CAVI) before and after 12 weeks intervention