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CTRI Number  CTRI/2025/04/084645 [Registered on: 11/04/2025] Trial Registered Prospectively
Last Modified On: 08/04/2025
Post Graduate Thesis  No 
Type of Trial  Interventional 
Type of Study   Preventive
Other (Specify) [Resistance training programme]  
Study Design  Single Arm Study 
Public Title of Study   The effect of exercise on muscle mass and strength in elderly diabetics with muscle weakness 
Scientific Title of Study   Identifying a Biomarker Panel for Diabetic Sarcopenia Based on their Differential Expression after Resistance Training  
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 Aiswarya P 
Designation  Assistant Professor(MD) 
Affiliation  K S Hegde Medical Academy Nitte DU 
Address  Department of Physiology K S Hegde Medical College Mangalore Karnataka

Dakshina Kannada
KARNATAKA
575018
India 
Phone  8848129926  
Fax    
Email  draiswarya.p@nitte.edu.in  
 
Details of Contact Person
Scientific Query
 
Name  Dr VK Sashindaran 
Designation  Director of Post graduate studies and Professor  
Affiliation  K.S Hegde Medical Academy Nitte DU 
Address  Department of General Medicine K S Hegde Medical College Mangalore Karnataka

Dakshina Kannada
KARNATAKA
575018
India 
Phone  9958826493  
Fax    
Email  vksashindran@gmail.com  
 
Details of Contact Person
Public Query
 
Name  Dr VK Sashindaran 
Designation  Director of Post graduate studies and Professor  
Affiliation  K.S Hegde Medical Academy Nitte DU 
Address  Department of General Medicine K S Hegde Medical College Mangalore Karnataka

Dakshina Kannada
KARNATAKA
575018
India 
Phone  9958826493  
Fax    
Email  vksashindran@gmail.com  
 
Source of Monetary or Material Support  
Research Society for the Study of Diabetes in India(RSSDI) Dr Sanjay Agarwals Aegle Clinic for Diabetes Care A 11 Narsimha Housing Society 194 Boat Club Road Pune 411001 India 
 
Primary Sponsor  
Name  Dr Aiswarya.P 
Address  Assistant Professor(MD) Department of Physiology K.S Hegde Medical College Mangalore, Karnataka  
Type of Sponsor  Private medical college 
 
Details of Secondary Sponsor  
Name  Address 
Dr V K Sashindaran  Director of Post graduate studies and Professor Department of General Medicine K.S Hegde Medical College Mangalore, Karnataka Email: vksashindran@gmail.com Mob:9958826493  
 
Countries of Recruitment     India  
Sites of Study  
No of Sites = 1  
Name of Principal Investigator  Name of Site  Site Address  Phone/Fax/Email 
Dr Aiswarya P  K S Hegde Medical Academy  Department of Community Medicine Room no 2 Rural Community Health Center Ira village Dakshina Kannada District
Dakshina Kannada
KARNATAKA 
8848129926

draiswarya.p@nitte.edu.in 
 
Details of Ethics Committee  
No of Ethics Committees= 1  
Name of Committee  Approval Status 
Central Ethics Committee  Approved 
 
Regulatory Clearance Status from DCGI  
Status 
Not Applicable 
 
Health Condition / Problems Studied  
Health Type  Condition 
Patients  (1) ICD-10 Condition: M625||Muscle wasting and atrophy, not elsewhere classified,  
 
Intervention / Comparator Agent  
Type  Name  Details 
Comparator Agent  NOT APPLICABLE  NOT APPLICABLE 
Intervention  Resistance training programme  It composed of 4 days training in a week for 8 weeks.the duration is 30 minutes per day.A certified gym trainer will be training the subjects . This has been designed based on previously published literature. Strenghth training will be given to different sets of muscle each day.it comprises of day 1 Hips and Thighs day 2 Upper Body RT (Pectoralis, Triceps, Biceps, Deltoids, Scapular Muscles) day 3 Glutes, Hams and Calf Muscles Day 4 Core and Balance exercises  
 
Inclusion Criteria  
Age From  40.00 Year(s)
Age To  65.00 Year(s)
Gender  Both 
Details  All the individuals with type 2 diabetes mellitus with sarcopenia attending, K.S Hegde Medical Academy, Rural health center Ira more than 40 years of age of either sex and willing to participate in the study
Diabetes defined as those patients with fasting glucose levels of greater than equal to 126 mg/dl or random blood glucose greater than equal to 200 mg/dl,
HbA1c greater than equal to 6.5%.
Sarcopenia as defined by EWGSOP SARC F less than 4 or Hand Grip Strength less than27 kg for males ,less than 18 kg for females.
 
 
ExclusionCriteria 
Details  Known cases of physical disabilities, chronic disease (tuberculosis, cancer, chronic renal failure and ischemic heart disease), muscular dystrophies, joint injuries ,patients on insulin therapy,  
 
Method of Generating Random Sequence   Not Applicable 
Method of Concealment   Not Applicable 
Blinding/Masking   Not Applicable 
Primary Outcome  
Outcome  TimePoints 
Biomarkers-coenzyme Q,Irisin, myostatin/follistatin ratio,BDNF,P3NP , miR1/206, miR 21, miR 23a, miR27a,/27b,miR29b-3p, miR 129-5P miR133a3P, miR 214, miR 486a-5p  Biomarkers-coenzyme Q,Irisin, myostatin/follistatin ratio,BDNF,P3NP , miR1/206, miR 21, miR 23a, miR27a,/27b,miR29b-3p, miR 129-5P miR133a3P, miR 214, miR 486a-5p 
 
Secondary Outcome  
Outcome  TimePoints 
Comparison of the biomarkers before and after intervention  Comparison of the biomarkers after 8 weeks of intervention 
 
Target Sample Size   Total Sample Size="20"
Sample Size from India="20" 
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 3 
Date of First Enrollment (India)   21/04/2025 
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="1"
Months="0"
Days="0" 
Recruitment Status of Trial (Global)   Not Yet Recruiting 
Recruitment Status of Trial (India)  Not Yet Recruiting 
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  

Diabetes mellitus is most common health burden especially in elderly.Sarcopenia is one of the complications which is been neglected, eventually can lead to poor quality of life. Recently WHO recognized sarcopenia as a disease. There is no definite treatment for it. Resistance training is proved to ameliorate sarcopenia to some extent. Diagnosing sarcopenia at preclinical stage would be required to establish preventive measures. There is no definite criteria to diagnose sarcopenia in India. The most accepted criteria to diagnose sarcopenia is EWGSOP which includes many tests and some are quite expensive. This is one of the reasons of neglecting the diagnosis. Defining a biomarker panel which can easily detect sarcopenia would be beneficial to detect sarcopenia at an early stage . Here we hypothes that after resistance training  there will be a differential expression of muscle specific biomarkers and myomiRNAs.The objective of the study is to compare the predictive value of biomarkers in diagnosing sarcopenia among type 2 diabetes mellitus patients and to compare the alterations in biomarkers before and after resistance training program among type 2 diabetic subjects with sarcopenia. It will be an analytical cohort study. The sample size calculated is 20.The subjects will be recruited based on inclusion criteria and will have to undergo 8 weeks of resistance training the blood samples will be collected for analysis before and after exercise.In this study certain muscle specific biomarkers  like Co Q 10 , Irisin, myostatin, Follistatin, BDNF,P3NP and molecular markers like miRNA specific to muscle miR1/206, miR 21, miR 23a, miR27a,/27b,miR29b-3p, miR 129-5P miR133a-3P, miR 214-5P, miR 486a-5p will be tested and compared . Considering  sarcopenia as a consequence of diabetes mellitus, standard care should be taken as of other complications of diabetes  . Therefore, the need for an accessible panel of biochemical markers that can be measured in blood to identify and monitor sarcopenia is necessary to reduce the burden not only at the individual level but also at the community level.

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revised European consensus on definition and diagnosis. Age Ageing. 2019 Jan 1;48(1):16–31. 

4  El-Sebaie M, Elwakil W. Biomarkers of sarcopenia: an unmet need. Egypt Rheumatol Rehabil. 2023 Sep 11;50(1):45. 

 

5   Simaitis S, Schulte-Körne B, Schiffer T, Bloch W, Predel HG, Brixius K, et al. Evidence for Training-Induced Changes in miRNA Levels in the Skeletal Muscle of Patients With Type 2 Diabetes Mellitus. Front Physiol [Internet]. 2020 Dec 3 [cited 2024 Apr 29];11.

   Drummond MJ, McCarthy JJ, Fry CS, Esser KA, Rasmussen BB. Aging differentially affects human skeletal muscle microRNA expression at rest and after an anabolic stimulus of resistance exercise and essential amino acids. Am J Physiol - Endocrinol Metab. 2008 Dec;295(6):E1333–40. 

 
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