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CTRI Number  CTRI/2018/05/014100 [Registered on: 25/05/2018] Trial Registered Retrospectively
Last Modified On: 19/05/2018
Post Graduate Thesis  Yes 
Type of Trial  Interventional 
Type of Study   Preventive 
Study Design  Randomized, Parallel Group Trial 
Public Title of Study   A study to test the effects of walking and weight lifting on blood glucose, muscle strength, energy utilization, total fat and muscle content within body among Indians with prediabetes 
Scientific Title of Study   A study to evaluate the effects of aerobic and resistance exercise on glycemic control, skeletal muscle function, metabolic activity and body composition among prediabetic Indians 
Trial Acronym   
Secondary IDs if Any  
Secondary ID  Identifier 
NIL  NIL 
 
Details of Principal Investigator or overall Trial Coordinator (multi-center study)  
Name  Sucharita S 
Designation  Professor  
Affiliation  St Johns Medical College 
Address  401, 3rd floor,Division of Nutrition, Department of Physiology St Johns Medical College, koramangala, Bangalore

Bangalore
KARNATAKA
560034
India 
Phone  8049466301  
Fax    
Email  sucharita.dr@gmail.com  
 
Details of Contact Person
Scientific Query
 
Name  Dr Pranathi Racha 
Designation  Tutor 
Affiliation  St Johns Medical College 
Address  401, 3rd floor,Division of Nutrition, Department of Physiology St Johns Medical College, koramangala, Bangalore

Bangalore
KARNATAKA
560034
India 
Phone  8049466301  
Fax    
Email  dr.pranathi.r@gmail.com  
 
Details of Contact Person
Public Query
 
Name  Dr Pranathi Racha 
Designation  Tutor 
Affiliation  St John s Medical College 
Address  401, 3rd floor,Division of Nutrition, Department of Physiology St Johns Medical College, koramangala, Bangalore

Bangalore
KARNATAKA
560034
India 
Phone  8049466301  
Fax    
Email  dr.pranathi.r@gmail.com  
 
Source of Monetary or Material Support  
Intramural grants, St. Johns Research Institute, Opposite BDA Complex, Johnnagar, Bangalore 560034 
 
Primary Sponsor  
Name  Dr Pranathi R 
Address  PhD Student and Tutor, 401, 3rd floor, division of nutrition, Department of Physiology, St. Johns Medical College 
Type of Sponsor  Other [Self] 
 
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 
Pranathi Racha student of Sucharita S  St. Johns Medical College and Hospital  Room No 401, Division of Nutrition, Department of Physiology, St Johns Medical College, Johnnagar, Bangalore 560034
Bangalore
KARNATAKA 
080-49466301

dr.pranathi.r@gmail.com 
 
Details of Ethics Committee  
No of Ethics Committees= 1  
Name of Committee  Approval Status 
IERB  Approved 
 
Regulatory Clearance Status from DCGI  
Status 
Not Applicable 
 
Health Condition / Problems Studied  
Health Type  Condition 
Healthy Human Volunteers  Prediabetes 
 
Intervention / Comparator Agent  
Type  Name  Details 
Intervention  3 groups  Aerobic exercise, resistance exercise and combination of both for 3 months 
Comparator Agent  nil  nil 
 
Inclusion Criteria  
Age From  30.00 Year(s)
Age To  60.00 Year(s)
Gender  Male 
Details  BMI:18.5-30kg/m2

Impaired oral glucose tolerance test and fasting plasma glucose(prediabetes: FBS 101-125mg/dl, PPBS 141-199 mg/dl, HbA1c 5.7-6.4%)

Normal oral glucose tolerance test and fasting plasma glucose(controls: FBS <100 mg/dl, PPBS <140 mg/dl, HbA1C <5.7%) 
 
ExclusionCriteria 
Details  1. Presence of chronic diseases (i.e., hypertension, tuberculosis, cancer, chronic renal failure, ischemic heart disease etc.,)
2. Any form of anemia
3. Any form of peripheral neuropathy
4. Muscular dystrophies
5. Any form of joint injuries or surgeries (knee and wrist)
6. History of osteoarthritis
7. Weight loss greater than 2 Kg in the past 6 months
8. Physical activity level > 1.75
9. Any history of chronic alcohol intake or tobacco consumption including cigarettes
10. Retinopathy
11. Any form of surgeries
 
 
Method of Generating Random Sequence   Other 
Method of Concealment   Sequentially numbered, sealed, opaque envelopes 
Blinding/Masking   Open Label 
Primary Outcome  
Outcome  TimePoints 
Glycated hemoglobin  baseline and after 12 weeks intervention 
 
Secondary Outcome  
Outcome  TimePoints 
Insulin sensitivity and beta cell functions,
Muscle quality,
Body composition,
mRNAs of intracellular signaling pathway

 
baseline and after 12 weeks intervention 
 
Target Sample Size   Total Sample Size="90"
Sample Size from India="90" 
Final Enrollment numbers achieved (Total)= "Applicable only for Completed/Terminated trials"
Final Enrollment numbers achieved (India)="Applicable only for Completed/Terminated trials" 
Phase of Trial   N/A 
Date of First Enrollment (India)   13/09/2017 
Date of Study Completion (India) Applicable only for Completed/Terminated trials 
Date of First Enrollment (Global)  Date Missing 
Date of Study Completion (Global) Applicable only for Completed/Terminated trials 
Estimated Duration of Trial   Years="5"
Months="0"
Days="0" 
Recruitment Status of Trial (Global)   Not Applicable 
Recruitment Status of Trial (India)  Open to Recruitment 
Publication Details   None yet 
Individual Participant Data (IPD) Sharing Statement

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

Brief Summary  

Diabetes is a major lifestyle disorder, prevalence of which has been increasing globally. Insulin resistance, a characteristic feature of Type 2 diabetes is due to reduced response of target tissues, such as skeletal muscle, liver and adipocytes to insulin. Skeletal muscle is the largest insulin-sensitive organ, accounting for more than 80% of insulin-stimulated glucose disposal [1, 2]. Skeletal muscle glucose disposal does not only depend only on its quantity, but also its quality (strength/mass) [3]. Moreover, it is also the quantitatively most dominant tissue with respect to lipid metabolism and the largest glycogen storage organ [4, 5]. Factors regulating fatty acid (FA) oxidation and mitochondrial functional capacity are likely to directly affect muscle metabolic function and, because of its 40% contribution to total body mass, might have a significant impact on whole-body energy metabolism [6]. At resting state itself, skeletal muscle accounts for about 30% of the metabolic rate [7]. Thus, the critical role that skeletal muscle plays in glycemic control and metabolic homeostasis makes it an organ of particular interest in obesity and type 2 diabetes (T2D). Understanding the role and pathogenesis of impaired muscle quality and the metabolic profile in Indian subjects (normal and pre-diabetic) might give insights into the mechanisms driving skeletal muscle glucose disposal in this population, as well as leads for intervention. Studies have shown that intervention involving moderate and high levels of cardiorespiratory fitness provide substantial protection against developing metabolic syndrome. Mechanisms through which exercise modifies chronic disease risk may be mediated by decreases in total and abdominal fat, plasma concentration of lipids, blood pressure, improvements in insulin sensitivity and glycemic control [8]. The focus of this study is to know the most effective exercise prescription for our prediabetic Indian population so as to improve glycemic control by improving the muscle quality and metabolic profile.

 

 
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