| CTRI Number |
CTRI/2024/11/077075 [Registered on: 20/11/2024] Trial Registered Prospectively |
| Last Modified On: |
12/11/2024 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Process of Care Changes
Other (Specify) |
| Study Design |
Other |
|
Public Title of Study
|
Effect of Exercise |
|
Scientific Title of Study
|
Effect of Exercise On Blood Glucose Levels And Lipid Profile (LDL, TRIGLYCERIDES & TOTAL CHOLESTEROL) With Relation To Body Mass Index In Young Adults |
| Trial Acronym |
NIL |
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Iti Mishra |
| Designation |
Junior Resident |
| Affiliation |
Ganesh Shankar Vidhyarthi Memorial, Medical College, Kanpur |
| Address |
Department Of Physiology, G.S.V.M. Medical College, Kanpur, Uttar Pradesh, India 208002
Department of Physiology, G.S.V.M. Medical College, Kanpur, Uttar Pradesh, India 208002
Kanpur Nagar
UTTAR PRADESH
208002
India |
| Phone |
208002 |
| Fax |
|
| Email |
mishraiti.03@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Jalaj Saxena |
| Designation |
Professor |
| Affiliation |
Ganesh Shankar Vidhyarthi Memorial, Medical College, Kanpur |
| Address |
Physiology Department, G.S.V.M. Medical College, Kanpur
Kanpur Nagar
UTTAR PRADESH
208002
India |
| Phone |
9450131597 |
| Fax |
|
| Email |
drjalajsaxena@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr Jalaj Saxena |
| Designation |
Professor |
| Affiliation |
Ganesh Shankar Vidhyarthi Memorial, Medical College, Kanpur |
| Address |
Physiology Department, G.S.V.M. Medical College, Kanpur
Physiology Department, G.S.V.M. Medical College, Kanpur
Kanpur Nagar
UTTAR PRADESH
208002
India |
| Phone |
9450131597 |
| Fax |
|
| Email |
drjalajsaxena@gmail.com |
|
|
Source of Monetary or Material Support
|
| Ganesh Shankar Vidyarthi Medical College, Kanpur, Uttar Pradesh, India, 208002 |
|
|
Primary Sponsor
|
| Name |
Iti Mishra |
| Address |
Physiology Department, G.S.V.M. Medical College, Kanpur |
| 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 |
| Iti Mishra |
Lala Lajpat Rai Hospital, Kanpur, Uttar Pradesh, India 208002 |
Exercise and Yoga Lab, Physiology Department.
Kanpur Nagar
UTTAR PRADESH |
7895797156
mishraiti.03@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Ethics Committee GSVM Medical College, Kanpur |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Healthy Human Volunteers |
Healthy human volunteers not suggestive of any present or past illness |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Comparator Agent |
Control group |
Control group will be healthy individuals of age group 17 to 25 years old who will not perform exercise that is performed by the study group. |
| Intervention |
Double arm study with control group |
Moderate exercise will made to be done with the help of Harvard step test. Harvard Step Test is a fitness test that uses different platform heights for men and women. The platform is 20 inches high for men and the platform is 16 inches high for women. pulse rate will be maintained between 100 to 125 beats per minute. |
|
|
Inclusion Criteria
|
| Age From |
17.00 Year(s) |
| Age To |
25.00 Year(s) |
| Gender |
Both |
| Details |
1 Healthy human volunteers between 17 to 25 years. |
|
| ExclusionCriteria |
| Details |
1 History of any kind of hormonal intake
2 History of Diabetes mellitus, Hypertension, Tuberculosis, Cardiovascular disease.
3 History of any cause suggestive of illness |
|
|
Method of Generating Random Sequence
|
Not Applicable |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Not Applicable |
|
Primary Outcome
|
| Outcome |
TimePoints |
1 Study the blood glucose levels of healthy human volunteers with relation to BMI
2 Study of lipid profile of healthy young adults with relation to BMI |
12 weeks |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
1 Effect of moderate exercise on blood glucose level of healthy young volunteers with relation to BMI
2 Effect of exercise on lipid profile in healthy young volunteers with relation to BMI |
12 weeks |
|
|
Target Sample Size
|
Total Sample Size="70"
Sample Size from India="70"
Final Enrollment numbers achieved (Total)= "0"
Final Enrollment numbers achieved (India)="70" |
|
Phase of Trial
|
N/A |
|
Date of First Enrollment (India)
|
25/11/2024 |
| Date of Study Completion (India) |
25/04/2025 |
| Date of First Enrollment (Global) |
Date Missing |
| Date of Study Completion (Global) |
Date Missing |
|
Estimated Duration of Trial
|
Years="0"
Months="3"
Days="0" |
|
Recruitment Status of Trial (Global)
|
Completed |
| Recruitment Status of Trial (India) |
Completed |
|
Publication Details
|
N/A |
|
Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
Response - NO
|
|
Brief Summary
|
This study aims to study the effect of blood glucose levels and lipid profile (LDL, Triglycerides & Total Cholesterol) of healthy young volunteers. Moderate exercise on regular basis improves the blood glucose levels and lipid profile. |