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
|
|
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
|
|
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. |