(1) Objective: The aim of this study is to investigate the interval training effectiveness on nitric oxide level and insulin resistance and some of cardiometabolic risk factors in type 2 diabetes patients. (2) Design: This study is a randomized controlled trial (3) Setting and conduct: This study will be done at endocrinology clinic of Karaj Rajaee hospital. Eligible subjects will randomly receive one of the following treatments; interval training exercise and usual physical activity. (4) Participants including major eligibility criteria: This clinical trial will be carry out on 30 female patients with type 2 diabetes and aged 40 to 55 years. (5) Intervention: thrity patients with type 2 diabetes will be assigned randomly into two groups and receive one of the following two interventions; 15 patients will receive interval training exercise with 18 sessions (three sessions per week), and 15 patients in control group will have usual physical activity. Each training session lasts 25 minutes and consists a single set of exercise with 10 time repetitions. Training will be perform on a cycle ergometer set in constant watt mode at a pedal cadence of 80 to 100 revolutions/min. Each repetition of the training takes 60 seconds and there will be a 60 seconds recovery period between each repetition. Each training session include a 3 min warm up and 2 min cooldown. All patients will receive regular routine diabetes care throughout the study. (6) Main outcome measures: The variables will be measured before and 24 to 72 hours after completing all training sessions: blood pressure, anthropometric measurements (body weight, height,), nitric oxide, fasting blood sugar, insulin resistance, glycosylated haemoglobin (HbA1C), fasting total cholesterol (TC), high-density lipoprotein (HDL), low-density lipoprotein (LDL) and triglyceride (TG)
General information
Acronym
IRCT registration information
IRCT registration number:IRCT2017082835945N1
Registration date:2017-10-30, 1396/08/08
Registration timing:registered_while_recruiting
Last update:
Update count:0
Registration date
2017-10-30, 1396/08/08
Registrant information
Name
Tahereh Arefirad
Name of organization / entity
Islamic Azad University, Science And Research Branch
Country
Iran (Islamic Republic of)
Phone
+98 21 8866 3344
Email address
tahereharefyrad@yahoo.com
Recruitment status
Recruitment complete
Funding source
Vice chancellor for research Alborz University of Medical Sciences
Expected recruitment start date
2017-10-23, 1396/08/01
Expected recruitment end date
2017-12-22, 1396/10/01
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Effect of interval training on nitric oxide level and insulin resistance and some of cardiometabolic risk factors in type 2 diabetes patients
Public title
Effect of interval training in diabetic patients
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria: Female patients between 40 to 55 years; patients diagnosed with type 2 diabetes mellitus; Not taking insulin for treatment; Baseline glycosylated hemoglobin (HbA1c) values of 53 and 75 mmol/mol (7 to 9%); No previous exercise training in the last 6 months.
Exclusion criteria: Patients diagnosed with nephropathy; retinopathy and/or severe neuropathy associated to diabetes; Patients diagnosed with severe cardiovascular or cerebrovascular diseases.
Age
From 40 years old to 55 years old
Gender
Female
Phase
3
Groups that have been masked
No information
Sample size
Target sample size:
30
Randomization (investigator's opinion)
Randomized
Randomization description
Blinding (investigator's opinion)
Not blinded
Blinding description
Placebo
Not used
Assignment
Parallel
Other design features
block randomization
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Ethics committee of Alborz University of Medical Sciences
Street address
School of Medicine, Alborz University of Medical Sciences, Baghestan Boulevard, Karaj, Iran.
City
Karaj
Postal code
Approval date
2017-06-10, 1396/03/20
Ethics committee reference number
abzums.rec.1396.48
Health conditions studied
1
Description of health condition studied
diabetes
ICD-10 code
E11
ICD-10 code description
Non-insulin-dependent diabetes mellitus
Primary outcomes
1
Description
fasting blood sugar
Timepoint
Before and 24 to 72 hours after completing all training sessions
Method of measurement
mg/dl
2
Description
Nitrit
Timepoint
Before and 24 to 72 hours after completing all training sessions
Method of measurement
μmol/l
3
Description
Insulin level
Timepoint
Before and 24 to 72 hours after completing all training sessions
Method of measurement
mU/l
Secondary outcomes
1
Description
Glycosylated Haemoglobin (HbA1C)
Timepoint
Before and 24 to 72 hours after completing all training sessions
Method of measurement
Percent
2
Description
Total Cholesterol
Timepoint
Before and 24 to 72 hours after completing all training sessions
Method of measurement
mg/dl
3
Description
High density lipoprotein (HDL)
Timepoint
Before and 24 to 72 hours after completing all training sessions
Method of measurement
mg/dl
4
Description
Low density lipoprotein (LDL)
Timepoint
Before and 24 to 72 hours after completing all training sessions
Method of measurement
mg/dl
5
Description
Triglyceride (TG)
Timepoint
Before and 24 to 72 hours after completing all training sessions
Method of measurement
mg/dl
6
Description
Body weight
Timepoint
Before and 24 to 72 hours after completing all training sessions
Method of measurement
Kg
7
Description
Diastolic blood pressure
Timepoint
Before and 24 to 72 hours after completing all training sessions
Method of measurement
ml/Hg
8
Description
Systolic blood pressure
Timepoint
Before and 24 to 72 hours after completing all training sessions
Method of measurement
ml/Hg
Intervention groups
1
Description
Intervention group: patients will receive interval training exercise with 18 sessions (three sessions per week). Each training session lasts 25 minutes and consists a single set of exercise with 10 time repetitions. Training will be perform on a cycle ergometer set in constant watt mode at a pedal cadence of 80–100 revolutions/min. Each repetition of the training takes 60 seconds and there will be a 60 seconds recovery pried between each repetition. Each training session include a 3-min warm-up and 2-min cool-down at 50 W for a total of 25 min.
Category
Lifestyle
2
Description
Control group: patients will have usual physical activity.
Category
Lifestyle
Recruitment centers
1
Recruitment center
Name of recruitment center
Endocrinology Clinic of Karaj Rajaee Hospital
Full name of responsible person
Taherh Arefirad
Street address
Shahid Rajaee Street, Shahid Beheshti Street, Karaj, Alborz Province
City
Karaj
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Vice chancellor for research Alborz University of Medical Sciences
Full name of responsible person
Mostafa Qorbani
Street address
Alborz University of Medical Sciences, Baghestan Boulevard, Karaj, Iran.
City
Karaj
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Vice chancellor for research Alborz University of Medical Sciences
Proportion provided by this source
100
Public or private sector
empty
Domestic or foreign origin
empty
Category of foreign source of funding
empty
Country of origin
Type of organization providing the funding
empty
Person responsible for general inquiries
Contact
Name of organization / entity
Islamic Azad University،Science And Research Branch
Full name of responsible person
Tahereh Arefirad
Position
PhD
Other areas of specialty/work
Street address
End of Sattari Highway, University Square, Shohaday-e Hesarak Boulevard, Tehran, Iran.
City
Tehran
Postal code
Phone
+98 21 8866 3344
Fax
Email
tahereharefyrad@yahoo.com
Web page address
Person responsible for scientific inquiries
Contact
Name of organization / entity
Islamic Azad University،Science And Research Branch
Full name of responsible person
Tahereh Arefirad
Position
PhD
Other areas of specialty/work
Street address
End of Sattari Highway, University Square, Shohaday-e Hesarak Boulevard, Tehran, Iran.
City
Tehran
Postal code
Phone
+98 21 8866 3344
Fax
Email
tahereharefyrad@yahoo.com
Web page address
Person responsible for updating data
Contact
Name of organization / entity
Islamic Azad University،Science And Research Branch
Full name of responsible person
Tahereh Arefirad
Position
PhD
Other areas of specialty/work
Street address
End of Sattari Highway, University Square, Shohaday-e Hesarak Boulevard, Tehran, Iran.
City
Tehran
Postal code
Phone
+98 21 8866 3344
Fax
Email
tahereharefyrad@yahoo.com
Web page address
Sharing plan
Deidentified Individual Participant Data Set (IPD)