| CTRI Number |
CTRI/2025/02/080245 [Registered on: 10/02/2025] Trial Registered Prospectively |
| Last Modified On: |
28/01/2025 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Drug Physiotherapy (Not Including YOGA) |
| Study Design |
Randomized, Parallel Group, Active Controlled Trial |
|
Public Title of Study
|
Impact of Combined Metformin Use and Aerobic Exercise on Metabolic and Inflammatory Markers in Type 2 Diabetes |
|
Scientific Title of Study
|
Synergistic Effects of Metformin and Aerobic Exercises on Osteocalcin, Insulin, IL-6, Glucose Levels and BMI on Patients with Diabetes Mellitus Type 2 |
| Trial Acronym |
NIL |
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Dr Imran Ahmad Khan |
| Designation |
Coordinator Pharmacy Department |
| Affiliation |
Muhammad Nawaz Sharif University of Agriculture Multan |
| Address |
Department of Pharmacy, 3rd Floor, Academic Block, Muhammad Nawaz Sharif University of Agriculture Multan
66000 Other |
| Phone |
03336120602 |
| Fax |
|
| Email |
imran.ahmad@mnsuam.edu.pk |
|
Details of Contact Person Scientific Query
|
| Name |
Dr Imran Ahmad Khan |
| Designation |
Coordinator Pharmacy Department |
| Affiliation |
Muhammad Nawaz Sharif University of Agriculture Multan |
| Address |
Department of Pharmacy, 3rd Floor, Academic Block, Muhammad Nawaz Sharif University of Agriculture Multan Muhammad Institute of Medical and Allied Sciences, Bosan Road, Multan, 66000, Pakistan
66000 Other |
| Phone |
03336120602 |
| Fax |
|
| Email |
imran.ahmad@mnsuam.edu.pk |
|
Details of Contact Person Public Query
|
| Name |
Dr. Maliha Khalid Khan |
| Designation |
Lecturer |
| Affiliation |
Muhammad Institute of Medical and Allied Sciences, Multan, Pakistan. |
| Address |
Muhammad Rehabilitation Clinic; First Floor, Muhammad Institute of Medical and Allied Sciences, Bosan Road, Multan, 66000, Pakistan Multan
66000 Other |
| Phone |
03126827130 |
| Fax |
|
| Email |
malihatareen1997@gmail.com |
|
|
Source of Monetary or Material Support
|
| Muhammad Institute of Medical and Allied Sciences, Multan,66000, Pakistan |
|
|
Primary Sponsor
|
| Name |
Muhammad Institute of Medical and Allied sciences Multan |
| Address |
Muhammad REHABILITATION Center 1st floor, Multan,66000, Pakistan |
| Type of Sponsor |
Other [Student fund] |
|
|
Details of Secondary Sponsor
|
| Name |
Address |
| Komal Ammar Bukhari |
Muhammad Rehabilitation Clinic; First Floor, Muhammad Institute of Medical and Allied Sciences, Bosan Road, Multan, 66000, Pakistan |
|
|
Countries of Recruitment
|
Pakistan |
|
Sites of Study
|
| No of Sites = 1 |
| Name of Principal
Investigator |
Name of Site |
Site Address |
Phone/Fax/Email |
| Dr Maliha Khalid Khan |
Muhammad Institute Of Medical And Allied Sciences |
Muhammad Rehabilitation Clinic; First Floor, Muhammad Institute of Medical and Allied Sciences, Bosan Road, Multan, 66000, Pakistan
|
03126827130
malihatareen1997@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Institutional Ethical Comitte Muhammad Institute of Medical and Allied Sciences Multan |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: E08-E13||Diabetes mellitus, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Comparator Agent |
Aerobic exercises |
Aerobic exercises
(30min/day) for 6 weeks
5 sessions/week
1-Walking
(5/day) 3METS
5 min slow
20 min brisk
5 min cool down Stretching
2-Cycling
5 min slow
20-30min moderate
5min easy
stretching
3-Eliptical training (tredmill)
Warm up 5 min
Moderate intensity 5 min
Low-moderate 10min
Cool down
streching
|
| Intervention |
Metformin |
Metformin(orally)
500mg/BD
(1000mg/day)
6 weeks
|
| Intervention |
Metformin + Aerobic exercises |
Metformin(orally)
500mg/BD
(1000mg/day)
6 weeks
Aerobic exercises
(30min/day) for 6 weeks
5 sessions/week
1-Walking
(5/day) 3METS
5 min slow
20 min brisk
5 min cool down
Stretching
2-Cycling
5 min slow walking
20-30min moderate
5 min easy stretching
3-Eliptical training (tredmill)
Warm up 5 min
Moderate intensity 5 min
Low-moderate 10min
Cool down
streching
|
|
|
Inclusion Criteria
|
| Age From |
20.00 Year(s) |
| Age To |
60.00 Year(s) |
| Gender |
Both |
| Details |
1. 20-60 years
2. Patients with T2DM
3. Both genders
|
|
| ExclusionCriteria |
| Details |
1. Vascular neoplasia
2. Fibromyalgia
3. Radiculopathy
4. Neuropathy
5. Tumor
6. Joint fractures
7. Vestibular problems
8. Congenital disorders
|
|
|
Method of Generating Random Sequence
|
Coin toss, Lottery, toss of dice, shuffling cards etc |
|
Method of Concealment
|
On-site computer system |
|
Blinding/Masking
|
Outcome Assessor Blinded |
|
Primary Outcome
|
| Outcome |
TimePoints |
Osteocalcin levels will be measured using serum concentration assays (ELISA).
Insulin levels will be assessed through fasting insulin tests
Interleukin-6 (IL-6) levels will be quantified via serum cytokine assays (ELISA).
Blood Glucose levels (Random and fasting blood glucose level)will be monitored using fasting blood glucose tests
Hemoglobin A1c (HbA1c) for long-term glycemic control.
Body Mass Index (BMI) will be calculated using height and weight measurements.
Diabetes self-management will be assessed using the Diabetes Self-Management Questionnaire (DSMQ) , while
Quality of life will be evaluated using the Diabetes Quality of Life (DQoL)
|
6 weeks |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
Lipid profile ( LDH,HDL,Triglycerides)
Blood pressure
VO2 max
Physical fitness will be evaluated using the 6-minute walk test
|
6 weeks |
|
|
Target Sample Size
|
Total Sample Size="377" Sample Size from India="0"
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
|
Phase 2 |
|
Date of First Enrollment (India)
|
20/02/2025 |
| Date of Study Completion (India) |
Applicable only for Completed/Terminated trials |
| Date of First Enrollment (Global) |
20/02/2025 |
| Date of Study Completion (Global) |
Applicable only for Completed/Terminated trials |
|
Estimated Duration of Trial
|
Years="0" Months="6" Days="10" |
|
Recruitment Status of Trial (Global)
|
Not Yet Recruiting |
| Recruitment Status of Trial (India) |
Not Applicable |
|
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
|
Patients with diabetes mellitus type 2 will come to Muhammad physical therapy clinic and rehabilitation centre, Multan. And after their consent, we will start our study on them. Data collection procedure Data will be collected after getting the approval from ethical committee, providing information to the patients Informed consent will be taken from the patient and the attendant. Osteocalcin levels will be measured using serum concentration assays (ELISA). Insulin levels will be assessed through fasting insulin tests Interleukin-6 (IL-6) levels will be quantified via serum cytokine assays (ELISA). Blood Glucose levels (Random and fasting blood glucose level)will be monitored using fasting blood glucose tests Hemoglobin A1c (HbA1c) for long-term glycemic control. Body Mass Index (BMI) will be calculated using height and weight measurements. Diabetes self-management will be assessed using the Diabetes Self-Management Questionnaire (DSMQ) , while Quality of life will be evaluated using the Diabetes Quality of Life (DQoL) Lipid profile ( LDH,HDL,Triglycerides) Blood pressure VO2 max Physical fitness will be evaluated using the 6-minute walk test Interventions Metformin dosage Dosage of 1000 mg/day of metformin is given to patients of all groups. Physical therapy interventions The treatment regime distributed in 6-week period 5 days per week exercise sessions lasted for 30 minutes in group B and C. Aerobic exercises include walking, cycling and elliptical training. Walking 5 days per week includes 5 min slow walking,20 min brisk,5 min cools down and stretching exercises Cycling exercise includes 5 min slow ,20-30 min moderate,5 min easy and stretching Elliptical training includes 5 min warm up, 5 min low intensity exercise,10 min moderate intensity exercise, cool down and stretching |