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CTRI Number  CTRI/2025/06/088261 [Registered on: 04/06/2025] Trial Registered Prospectively
Last Modified On: 29/05/2025
Post Graduate Thesis  Yes 
Type of Trial  Observational 
Type of Study   Cross Sectional Study 
Study Design  Other 
Public Title of Study   Musculoskeletal Manifestations in patients with Type 2 Diabetes Mellitus and its relation to glycemic control  
Scientific Title of Study   Musculoskeletal Manifestations in patients with Type 2 Diabetes Mellitus and its relation to glycemic control at a tertiary care centre : A Cross-sectional Observational Study 
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 Madhavi Mathkar 
Designation  Junior Resident 
Affiliation  Dr DY Patil Medical College, Navi Mumbai 
Address  Department of General Medicine, 3rd floor , DY Patil Hospital, Nerul

Thane
MAHARASHTRA
400706
India 
Phone  9920188402  
Fax    
Email  madhavigo1999@gmail.com  
 
Details of Contact Person
Scientific Query
 
Name  Dr Smita Patil 
Designation  Head of Department  
Affiliation  Dr DY Patil Medical College, Navi Mumbai 
Address  Department of General Medicine, 3rd floor , DY Patil Hospital, Nerul

Thane
MAHARASHTRA
400706
India 
Phone  9821027742  
Fax    
Email  smita.patil@dypatil.edu  
 
Details of Contact Person
Public Query
 
Name  Dr Madhavi Mathkar 
Designation  Junior Resident 
Affiliation  Dr DY Patil Medical College, Navi Mumbai 
Address  Department of General Medicine, 3rd floor, DY Patil Hospital, Nerul

Thane
MAHARASHTRA
400706
India 
Phone  9920188402  
Fax    
Email  madhavigo1999@gmail.com  
 
Source of Monetary or Material Support  
NIL 
 
Primary Sponsor  
Name  Dr Madhavi Mathkar 
Address  Department of General Medicine, DY Patil Medical College, Navi Mumbai, Maharashtra, India 400706 
Type of Sponsor  Other [Self] 
 
Details of Secondary Sponsor  
Name  Address 
NIL  NIL 
 
Countries of Recruitment     India  
Sites of Study  
No of Sites = 1  
Name of Principal Investigator  Name of Site  Site Address  Phone/Fax/Email 
Dr Madhavi Mathkar  DY Patil Medical College, Navi Mumbai  3rd Floor, Department of General Medicine, DY Patil Hospital, Dr D Y Patil Vidyanagar, Sector 7, Nerul, Navi Mumbai, Maharashtra 400706
Thane
MAHARASHTRA 
9920188402

madhavigo1999@gmail.com 
 
Details of Ethics Committee  
No of Ethics Committees= 1  
Name of Committee  Approval Status 
The Institutional Ethics Committee for Biomedical and Health research (IECBH)   Approved 
 
Regulatory Clearance Status from DCGI  
Status 
Not Applicable 
 
Health Condition / Problems Studied  
Health Type  Condition 
Patients  (1) ICD-10 Condition: E116||Type 2 diabetes mellitus with other specified complications,  
 
Intervention / Comparator Agent  
Type  Name  Details 
Intervention  NIL  NIL 
Comparator Agent  NIL  NIL 
 
Inclusion Criteria  
Age From  18.00 Year(s)
Age To  95.00 Year(s)
Gender  Both 
Details  The criteria for diagnosis of diabetes mellitus is according to
the criteria laid down by the American Diabetes Association.
Fasting blood glucose greater than 126 mg per dl
Postprandial blood glucose more than 200 mg per dl.
Symptoms of diabetes plus random blood glucose more than200 mg per dl
Hba1c more than 6.5g percent 
 
ExclusionCriteria 
Details  1. Patients with a history of injury or fractures in the joint region.
2. Patients with a history of chronic liver disease.
3. Patients with a history of end-stage renal disease.
4. Patients with rheumatoid arthritis, Systemic lupus
erythematosus and other connective tissue diseases. 
 
Method of Generating Random Sequence   Not Applicable 
Method of Concealment   Not Applicable 
Blinding/Masking   Not Applicable 
Primary Outcome  
Outcome  TimePoints 
To study the types of musculoskeletal manifestations in patients
with Type 2 Diabetes Mellitus (T2DM) and their clinical profile 
1 year 
 
Secondary Outcome  
Outcome  TimePoints 
1. To assess the association between glycemic control levels
(measured by HbA1c) & the presence/severity of
musculoskeletal manifestations. 
1 year 
2. To explore whether specific diabetic treatments (e.g. oral
hypoglycemic agents, insulin therapy) & or risk factors (such
as age, duration of diabetes, BMI) influence the development or
progression of musculoskeletal conditions. 
1 year 
 
Target Sample Size   Total Sample Size="90"
Sample Size from India="90" 
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   N/A 
Date of First Enrollment (India)   16/06/2025 
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  

Type 2 diabetes mellitus (T2DM) is a common chronic metabolic

disorder characterized by insulin resistance and relative insulin

deficiency . Its global prevalence continues to increase, posing

significant challenges to health systems worldwide. In addition to its

well-documented association with cardiovascular disease,

nephropathy and retinopathy , new research suggests that T2DM

may also contribute to the development and progression of

rheumatological diseases. Rheumatic symptoms include many

diseases that affect the joints, bones, muscles and connective tissues.

These conditions, such as osteoarthritis, rheumatoid arthritis and

diabetic hand syndrome, often coexist with diabetes, making patient

care more complex. The interaction between diabetes and

rheumatological diseases appears to be multifaceted and may involve

shared pathophysiological mechanisms and overlapping risk

factors. For example, a study found that in a group with 96

diabetics, prevalence of Carpal Tunnel Syndrome was about 20%.

In a comparison of 200 patients with type 1 or type 2 diabetes with

100 controls, the prevalence of hand or shoulder disorders was

higher in the patients with diabetes 36 versus 9 percent and

correlated with the duration, but not the type, of diabetes.

Glycemic control, the cornerstone of diabetes management, plays a

key role in mitigating micro and macrovascular complications,including musculoskeletal complications. In a study of 100

randomly selected patients with diabetes in an outpatient clinic,

50 patients were found to have hand abnormalities with more than

one abnormality found in 26. It is popularly hypothesised that these

musculoskeletal manifestations could be due to accumulation of

advanced glycation end products (AGEs). However, its effect

on rheumatological outcomes has not been sufficiently studied.

Understanding the relationship between glycemic control and

rheumatological manifestations can inform a holistic approach to

patient care, emphasizing integrated treatment strategies.

Addressing these knowledge gaps, this study aims to improve

understanding of T2DM comorbidities and help optimize therapeutic

interventions and clinical outcomes. Using a systematic approach,

valuable information on the complex relationship between T2DM,

rheumatological manifestations and glycemic control can be

obtained, contributing to better treatment strategies and patient

care.

Aim is to study the types of musculoskeletal manifestations in patients

with Type 2 Diabetes Mellitus (T2DM) and their clinical profile.

Objectives

1. To assess the association between glycemic control levels

(measured by HbA1c) and the presence/severity of

musculoskeletal manifestations.

2. To explore whether specific diabetic treatments (e.g. oral

hypoglycemic agents, insulin therapy) and or risk factors (such

as age, duration of diabetes, BMI) influence the development or

progression of musculoskeletal conditions.

 
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