CTRI

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CTRI Number

CTRI/2025/07/090494 [Registered on: 08/07/2025] Trial Registered Prospectively

Last Modified On:

01/11/2025

Post Graduate Thesis

Yes

Type of Trial

Observational

Type of Study

Cross Sectional Study

Study Design

Other

Public Title of Study

A study to assess handgrip strength in people with type 2 diabetes mellitus and how it relates to body measurements and blood sugar levels

Scientific Title of Study

Study of handgrip strength in patients with type 2 diabetes mellitus and its association with anthropometric and glycemic variables

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 Hareesh Kumar M
Designation	Primary DNB Resident (General medicine)
Affiliation	Metrounited Healthcare
Address	Metrounited Healthcare, Shivmurthy Circle, Savalanga Road, Jayanagar, Shivamogga, Karnataka, 577201 Shimoga KARNATAKA 577201 India
Phone	8500611846
Fax
Email	murarkarhareesh@gmail.com

Details of Contact Person
Scientific Query

Name	Dr Pruthvi B C
Designation	Medical Director, MD MEDICINE
Affiliation	Metrounited Healthcare
Address	Metrounited Healthcare, Shivmurthy Circle, Savalanga Road, Jayanagar, Shivamogga, Karnataka, 577201 Shimoga KARNATAKA 577201 India
Phone	9448064080
Fax
Email	drpruthvibc@gmail.com

Details of Contact Person
Public Query

Name	Dr Hareesh Kumar M
Designation	Primary DNB Resident (General medicine)
Affiliation	Metrounited Healthcare
Address	Metrounited Healthcare, Shivmurthy Circle, Savalanga Road, Jayanagar, Shivamogga, Karnataka, 577201 KARNATAKA 577201 India
Phone	8500611846
Fax
Email	murarkarhareesh@gmail.com

Source of Monetary or Material Support

No monetary or material support was received for this study. It is being conducted as part of a postgraduate thesis using institutional resources

Primary Sponsor

Name	Metrounited Healthcare
Address	Metrounited Healthcare, Shivmurthy Circle, Savalanga Road, Jayanagar, Shivamogga, Karnataka, 577201
Type of Sponsor	Private hospital/clinic

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 Pruthvi B C	Metrounited Healthcare	Metrounited Healthcare, Shivmurthy Circle, Savalanga Road, Jayanagar, Shivamogga, Karnataka, 577201 Shimoga KARNATAKA	9448064080 drpruthvibc@gmail.com

Details of Ethics Committee

No of Ethics Committees= 1
Name of Committee	Approval Status
Institutional Review Board of Sankara Eye Hospital	Approved

Regulatory Clearance Status from DCGI

Status

Not Applicable

Health Condition / Problems Studied

Health Type	Condition
Patients	(1) ICD-10 Condition: E119\|\|Type 2 diabetes mellitus without complications,

Intervention / Comparator Agent

Type	Name	Details
Intervention	Nil	Nil

Inclusion Criteria

Age From	18.00 Year(s)
Age To	80.00 Year(s)
Gender	Both
Details	All patients already diagnosed with type 2 Diabetes Mellitus according to recent ADA guidelines and either attending outpatient department or admitted in medicine wards of Department of Medicine of the Metrounited Healthcare, Shivamogga Duration of DM type 2 atleast 5 years or more

ExclusionCriteria

Details

Any history of pain and musculoskeletal problems in the shoulder, arm or hand
Brachial plexus injury
Cervical radiculopathy
Trauma
Patients on treatment for diabetic neuropathy or neuropathy of any other cause

Method of Generating Random Sequence

Not Applicable

Method of Concealment

Not Applicable

Blinding/Masking

Not Applicable

Primary Outcome

Outcome	TimePoints
1.To study Hand grip strength in patients diagnosed with type 2 diabetes mellitus as compared to normal individuals 2. To assess the association between Hand grip strength and glycemic variables like FBS PPBS and HBA1C 3. To assess the association between Hand grip strength and anthropometric Variables like BMI and Waist to hip ratio	Duration of diabetes mellitus type 2 of atleast 5 years

Secondary Outcome

Outcome	TimePoints
Nil	Nil

Target Sample Size

Total Sample Size="300"
Sample Size from India="300"
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)

15/07/2025

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="2"
Months="0"
Days="0"

Recruitment Status of Trial (Global)
Modification(s)

Not Applicable

Recruitment Status of Trial (India)

Closed to Recruitment of Participants

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

This cross-sectional observational study is going to be conducted in a tertiary care center Metrounited Healthcare, Shivamogga,Karnataka over a period of one and half year. Institutional ethical clearance will be taken from the Institutional ethical committee and individual consent will be taken from each patient. Subjects will be taken for the current study amongst the individuals either attending the outpatient department or getting admitted to the in-patient wards of Metrounited Healthcare diagnosed with type-2 diabetes mellitus after considering inclusion and exclusion criteria, along with that age and sex matched controls will be taken for each study individual. Patient who fulfill inclusion criteria will thoroughly be interviewed for demographic data and detailed history as per attached proforma. Further these patients will be subjected to a physical examination and appropriate investigations.