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CTRI Number  CTRI/2012/09/002974 [Registered on: 10/09/2012] Trial Registered Prospectively
Last Modified On: 16/10/2012
Post Graduate Thesis  No 
Type of Trial  Interventional 
Type of Study   Preventive
Other (Specify) [Exercise]  
Study Design  Randomized, Parallel Group Trial 
Public Title of Study   Comparison of high intensity training with regular aerobic exercise in people at risk for developing Diabetes 
Scientific Title of Study   COMPARATIVE STUDY OF TRADITIONAL AEROBIC EXERCISE VERSUS SPRINT INTERVAL TRAINING IN PREDIABETES: A RANDOMIZED CONTROLLED TRIAL  
Trial Acronym   
Secondary IDs if Any  
Secondary ID  Identifier 
U1111-1133-9202  UTN 
 
Details of Principal Investigator or overall Trial Coordinator (multi-center study)  
Name  Dr Khaled Mohsin Badaam 
Designation  Assistant Professor 
Affiliation  Government Medical College, Aurangabad 
Address  Department of Physiology, Government Medical College, Panchakki Road,

Aurangabad
MAHARASHTRA
431001
India 
Phone  02402402412  
Fax    
Email  khalid_badaam@yahoo.com  
 
Details of Contact Person
Scientific Query  
Name  Dr Urjita Sudhish Zingade 
Designation  Professor 
Affiliation  Government Medical College, Aurangabad 
Address  Department of Physiology, BJ Medical College, Near Pune Railway Station,

Pune
MAHARASHTRA
411001
India 
Phone  02026128000  
Fax    
Email  uszingade@gmail.com  
 
Details of Contact Person
Public Query  
Name  Dr Khaled Mohsin Badaam 
Designation  Assistant Professor 
Affiliation  Government Medical College, Aurangabad 
Address  Department of Physiology, Government Medical College, Panchakki Road,


MAHARASHTRA
431001
India 
Phone  02402402412  
Fax    
Email  khalid_badaam@yahoo.com  
 
Source of Monetary or Material Support  
Govt Medical College, Aurangabad 
 
Primary Sponsor  
Name  Government Medical College Aurangabad  
Address  Department of Physiology, Government Medical College, Panchakki Road, Aurangabad. 
Type of Sponsor  Government medical college 
 
Details of Secondary Sponsor  
Name  Address 
NIL  NIL 
 
Countries of Recruitment     India  
Sites of Study  
No of Sites = 1  
Name of Principal Investigator  Name of Site  Site Address  Phone/Fax/Email 
Dr Khaled Mohsin Badaam  Government Medical College, Aurangabad.  Department of Physiology, Government Medical College, Panchakki Road,
Aurangabad
MAHARASHTRA 		 02402402412

khalid_badaam@yahoo.com 
 
Details of Ethics Committee  
No of Ethics Committees= 1  
Name of Committee  Approval Status 
Institutional Ethics Committee, Government Medical College, Aurangabad.   Approved 
 
Regulatory Clearance Status from DCGI  
Status 
Not Applicable 
 
Health Condition / Problems Studied  
Health Type  Condition 
Patients  Prediabetes: Impaired fasting glucose (IFG) – Fasting Plasma Glucose 100-125 mg/dl OR Impaired glucose tolerance((IGT)- 2hr Post Prandial Glucose 140-199mg/dl ,  
 
Intervention / Comparator Agent  
Type  Name  Details 
Intervention  Sprint Interval Training  60 seconds of intense exercise followed by 90 seconds of rest, repeated for 4 cycles making a total of 10 minutes a day. Subjects using this method trained 3 times per week.  
Comparator Agent  Traditional aerobic exercise  30 minutes a day aerobic exercise as per ADA guidelines for 5 days a week  
 
Inclusion Criteria  
Age From  25.00 Year(s)
Age To  40.00 Year(s)
Gender  Male 
Details  1) Prediabetes: Impaired fasting glucose (IFG) – Fasting Plasma Glucose 100-125 mg/dl OR Impaired glucose tolerance((IGT)- 2hr Post Prandial Glucose
140-199mg/dl
2) Age group: 25 to 40 years.
3) Asymptomatic males with a normal baseline ECG
 
 
ExclusionCriteria 
Details  1.Resting blood pressure greater than or equal to 160/100 mm Hg
2. Triglycerides greater than or equal to 500 mg/dL
3. Factors that may limit adherence to intervention or affect conduct of the trial such as lack of time, amount of travel, and/or work or family stressors
4. Unable or willing to communicate with staff, to provide written informed consent, or accept the randomized assignment
5. Failure to complete behavioral run-in and baseline testing
6. Not physically capable of performing the exercise required of the study protocols
7. Plans to be away >4 weeks in the next 6 months
8. Lack of support from primary health care provider or family members
9. Significant weight loss in the past year (>20 kg) or current use of weight loss medications
10. Current diagnosis of schizophrenia, or other psychotic disorders, or bipolar disorder
11. History of bariatric surgery within last 3 years
12. Other temporary intervening event, such as sick spouse, bereavement, or recent move
13. Other medical, psychiatric, or behavioral limitations that in the view of the principal investigator may interfere with study participation or the ability to follow the intervention protocol
14. Underlying diseases or conditions likely to limit lifespan and/or affect the safety of the intervention
15. Self-report HIV or tuberculosis
16. History or evidence of serious arrhythmias, cardiomyopathy, congestive heart failure, aortic aneurysm, or heart transplantation
17. Renal disease: currently receiving dialysis
18. Type I diabetes mellitus
19. Type 2 diabetes mellitus, defined as: Fasting plasma glucose levels greater than or equal to 126 mg/dL 2-hour postprandial Oral Glucose Tolerance Test results greater than or equal to 200 mg/dL
20. Any other medical condition or disease that is life threatening or that can interfere with or be aggravated by exercise
21. Chronic obstructive lung disease, peripheral vascular disease or angina that limits ability to follow exercise protocol
22. Advanced neuropathy or retinopathy
23. Consuming alcoholic beverages, Smoker or have used nicotine/tobacco products within the last 12 months
 
 
Method of Generating Random Sequence   Computer generated randomization 
Method of Concealment   Centralized 
Blinding/Masking   Participant, Investigator, Outcome Assessor and Date-entry Operator Blinded 
Primary Outcome  
Outcome  TimePoints 
Insulin Resistance by Homeostatic Model Assessment (HOMA-IR)  3 months 
 
Secondary Outcome  
Outcome  TimePoints 
HOMA1-IS%, HOMA-2S%, QUICKI, HOMA-1β% and HOMA-2β%, Lipid Profile, HbA1c , VO2max, Waist Hip ratio and Body Mass Index   3 months 
 
Target Sample Size   Total Sample Size="160"
Sample Size from India="160" 
Final Enrollment numbers achieved (Total)= ""
Final Enrollment numbers achieved (India)="" 
Phase of Trial   N/A 
Date of First Enrollment (India)   11/09/2012 
Date of Study Completion (India) Date Missing 
Date of First Enrollment (Global)  Date Missing 
Date of Study Completion (Global) Date Missing 
Estimated Duration of Trial   Years="0"
Months="5"
Days="0" 
Recruitment Status of Trial (Global)
Modification(s)  		 Not Applicable 
Recruitment Status of Trial (India)  Completed 
Publication Details    
Individual Participant Data (IPD) Sharing Statement

Will individual participant data (IPD) be shared publicly (including data dictionaries)?  

Brief Summary  

The present study is being carried out to compare the effects of traditional aerobic training and Sprint Interval Training on Insulin resistance, Lipid profile, HbA1c, Waist Hip ratio and Body Mass Index in subjects of Prediabetes.

160 patients of Prediabetes will be enrolled for the study. Diagnosis of prediabetes will be according to American Diabetes Association (ADA) guidelines. 

By computer generated Randomization and proper allocation concealment and blinding, the study subjects will be allocated to aerobic training and sprint interval training groups. 

Following parameters will be measured at the beginning of study and after 3 months.

Primary outcome: HOMA IR, 

Secondary outcome: HOMA1-IS%, HOMA-2S%, QUICKI, HOMA-1β% and HOMA-2β%, Lipid Profile, HbA1c , VO2max, Waist Hip ratio and Body Mass Index.

Statistical analysis will be done to compare the effect of both interventions.

  

 
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