FULL DETAILS (Read-only)  -> Click Here to Create PDF for Current Dataset of Trial
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  
Status 
Not Applicable 
 
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

 
Close