Musculoskeletal Manifestations in patients with Type 2 DiabetesMellitus and its relation to glycemic control

Not yet recruiting

Conditions: Type 2 diabetes mellitus with other specified complications,

Registration Number: CTRI/2025/06/088261

Lead Sponsor: Dr Madhavi Mathkar

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.

Detailed Description: Not available

Recruitment & Eligibility

Status: Not Yet Recruiting

Sex: All

Target Recruitment: 90

Inclusion Criteria

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.

Exclusion Criteria

Patients with a history of injury or fractures in the joint region.
Patients with a history of chronic liver disease.
Patients with a history of end-stage renal disease.
Patients with rheumatoid arthritis, Systemic lupus erythematosus and other connective tissue diseases.

Study & Design

Study Type: Observational

Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
To study the types of musculoskeletal manifestations in patients	1 year
with Type 2 Diabetes Mellitus (T2DM) and their clinical profile	1 year

Secondary Outcome Measures

Name	Time	Method
1. To assess the association between glycemic control levels	(measured by HbA1c) & the presence/severity of
2. To explore whether specific diabetic treatments (e.g. oral	hypoglycemic agents, insulin therapy) & or risk factors (such

Trial Locations

Locations (1): DY Patil Medical College, Navi Mumbai
🇮🇳
Thane, MAHARASHTRA, India
DY Patil Medical College, Navi Mumbai
🇮🇳Thane, MAHARASHTRA, India
Dr Madhavi Mathkar
Principal investigator
9920188402
madhavigo1999@gmail.com