| 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
|
|
|
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. 1 Mesinovic J, Zengin A, De Courten B, Ebeling PR, Scott D. Sarcopenia and type 2 diabetes mellitus: a bidirectional relationship. Diabetes Metab Syndr Obes Targets Ther. 2019;12:1057–72. 2 D S, B de C, Pr E. Sarcopenia: a potential cause and consequence of type 2 diabetes in Australia’s ageing population? Med J Aust [Internet]. 2016 Oct 3 [cited 2024 Mar 14];205(7). Available from: https://pubmed.ncbi.nlm.nih.gov/27681976/ 3 Cruz-Jentoft AJ, Bahat G, Bauer J, Boirie Y, Bruyère O, Cederholm T, et al. Sarcopenia: 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. 6 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. |