Type2diabetesNCT05939908
Assessment of Hand Grip Strength Using Jamar Dynamometer
An observational study of Type2diabetes, run by Diabetes Foundation, India at 1 site in India.
Trial summary
Hand grip strength will be measured for all the type 2 diabetic patients. Measurement of maximal grip strength will be performed using Jamar dynamometers, which estimate the muscle strength primarily generated by the flexor muscles of the hand and the forearm. Read more about this study
- Who is it for?
- Ages 20 to 60 yearsHealthy volunteers can take part
- Conditions the study is for
- Type2diabetes
- What is being tested?
- Using Jamar Dynamometer for Grip Strength.
- How many people
- 5,000 participants
- Where
- 1 siteIndia
- Study dates
- 1 Jul 2023to 30 Jan 2025
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 20 to 60 years
- All sexes
- Healthy volunteers accepted
- Adult
Study population: T2DM patient visiting Fortis CDOC Hospital and meeting the Inclusion Criteria will be enrolled in the study.
Who may be able to join
- All patients with Type 2 diabetes of any duration coming for first time in OPD
Who cannot join
- Patients with hand fracture
- Thyroid dysfunction
- Any musculoskeletal condition causing difficulty in holding the dynamometer
- Patients with type1 diabetes (T1DM) and gestational diabetes (GDM)
Trial locations and contacts
1 site in 1 country.
India1 site, 1 recruiting
- Recruiting
Fortis CDOC Hospital
Delhi, 110048
Anoop Misra, MD, 01149101222, anoopmisra@gmail.com
Anoop Misra, MD
About this study
Official title: To Assess Prevalence of Sarcopenia Using Hand Grip Strength (HGS) as a Marker in Patients With T2DM
Hand grip strength will be measured for all the type 2 diabetic patients. Measurement of maximal grip strength will be performed using Jamar dynamometers, which estimate the muscle strength primarily generated by the flexor muscles of the hand and the forearm. The Jamar displays grip force in both pounds and kilograms, with a maximum of 200 lb (90 kg). It has a peak-hold needle that automatically retains the highest reading until reset. The Jamar test is isometric, with no perceptible motion of the handle, regardless of the grip strength applied. The participants will be encouraged to produce their maximal grip strength. Three trials will be recorded, consisting of a 2-4-second maximal contraction, with a 30-second rest period between each trial. The average of the three readings will be taken.
Read the detailed description
Sarcopenia is an age related, progressive, and generalized skeletal muscle disorder involving the accelerated loss of muscle mass and function and physical performance below a defined threshold1. It is associated with increased adverse outcomes including increased risk falls, physical frailty, prolonged hospitalization, dependency, physical disability and impairment, limitation of mobility, decreased quality of life and increased mortality. Sarcopenia is known to be more prevalent in older populations, but the decline in muscle mass starts from ~40 years onwards2.
Sarcopenia not only affects the ability to lead an active lifestyle but also contributes to increased obesity, type 2 diabetes (T2DM) reduced quality of life, osteoporosis, and metabolic health1.
Hand grip strength (HGS) is considered as an important value when diagnosing sarcopenia. Lower muscle strength using HGS is mandatory to diagnose sarcopenia. EWGSOP group recommends that the mean reference cut-off value of hand grip is < 30 kg in men and < 20 kg in women.
There is evidence that strength could be an important risk factor for diabetes. Low hand-grip strength has been predictive of incident diabetes in prospective cohort studies3. Lower grip strength was associated with higher prevalence of diabetes, independent of confounding factors, across all ethnicities in both men and women. Diabetes prevalence was approximately three- to fourfold higher in South Asian participants across all levels of grip strength3 .
However, there are no studies in India assessing sarcopenia in type 2 diabetic patients.
- Conditions
- Type2diabetes
- Being tested
- Using Jamar Dynamometer for Grip Strength.
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Using Jamar Dynamometer for Grip Strength.Other
Hand grip strength as a marker by using JAMAR hand grip dynamometer in patients with T2DM.
What is being measured
The primary outcome is the main question the study is designed to answer.
Comparison of age and gender specific prevalence of sarcopenia using HGS in patients with T2DM
Measured: 6 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted11 Jul 2023
- Study start1 Jul 2023
- Primary completion31 Dec 2024 (estimated)
- Study completion30 Jan 2025 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Type2diabetesStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Other
- Time perspective
- Other
- Enrolment
- 5,000 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Diabetes Foundation, India
- Sponsor type
- University, hospital or other
- Collaborators
- National Diabetes Obesity and Cholesterol Foundation
- Responsible party
- Principal investigator, Dr Anoop Misra, Diabetes Foundation, India
- Investigators
- Anoop Misra, MD, Principal investigator, Fortis CDOC Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05939908
- Sponsor's protocol ID
- HGS
- Status last verified
- Jul 2023
- First submitted
- 3 Jul 2023
- Last updated
- 11 Jul 2023
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 11 Jul 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- To Assess Prevalence of Sarcopenia Using Hand Grip Strength (HGS) as a Marker in Patients With T2DM
- ClinicalTrials.gov ID
- NCT05939908
- Acronym / sponsor ID
- HGS
- Conditions
- Type2diabetes
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 5,000 participants (estimated)
- Lead sponsor
- Diabetes Foundation, IndiaUniversity, hospital or other
- Collaborators
- National Diabetes Obesity and Cholesterol Foundation
- Study start
- 1 Jul 2023 (actual)
- Primary completion
- 31 Dec 2024 (estimated)
- Study completion
- 30 Jan 2025 (estimated)
- First posted
- 11 Jul 2023 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
Hand grip strength will be measured for all the type 2 diabetic patients. Measurement of maximal grip strength will be performed using Jamar dynamometers, which estimate the muscle strength primarily generated by the flexor muscles of the hand and the forearm. The Jamar displays grip force in both pounds and kilograms, with a maximum of 200 lb (90 kg). It has a peak-hold needle that automatically retains the highest reading until reset. The Jamar test is isometric, with no perceptible motion of the handle, regardless of the grip strength applied. The participants will be encouraged to produce their maximal grip strength. Three trials will be recorded, consisting of a 2-4-second maximal contraction, with a 30-second rest period between each trial. The average of the three readings will be taken.
Detailed description
Sarcopenia is an age related, progressive, and generalized skeletal muscle disorder involving the accelerated loss of muscle mass and function and physical performance below a defined threshold1. It is associated with increased adverse outcomes including increased risk falls, physical frailty, prolonged hospitalization, dependency, physical disability and impairment, limitation of mobility, decreased quality of life and increased mortality. Sarcopenia is known to be more prevalent in older populations, but the decline in muscle mass starts from ~40 years onwards2.
Sarcopenia not only affects the ability to lead an active lifestyle but also contributes to increased obesity, type 2 diabetes (T2DM) reduced quality of life, osteoporosis, and metabolic health1.
Hand grip strength (HGS) is considered as an important value when diagnosing sarcopenia. Lower muscle strength using HGS is mandatory to diagnose sarcopenia. EWGSOP group recommends that the mean reference cut-off value of hand grip is < 30 kg in men and < 20 kg in women.
There is evidence that strength could be an important risk factor for diabetes. Low hand-grip strength has been predictive of incident diabetes in prospective cohort studies3. Lower grip strength was associated with higher prevalence of diabetes, independent of confounding factors, across all ethnicities in both men and women. Diabetes prevalence was approximately three- to fourfold higher in South Asian participants across all levels of grip strength3 .
However, there are no studies in India assessing sarcopenia in type 2 diabetic patients.
Study design
- Observational model
- Other
- Time perspective
- Other
Who may qualify
- Ages
- 20 to 60 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
- Study population
- T2DM patient visiting Fortis CDOC Hospital and meeting the Inclusion Criteria will be enrolled in the study.
Key inclusion criteria (1 listed)
- All patients with Type 2 diabetes of any duration coming for first time in OPD
Key exclusion criteria (4 listed)
- Patients with hand fracture
- Thyroid dysfunction
- Any musculoskeletal condition causing difficulty in holding the dynamometer
- Patients with type1 diabetes (T1DM) and gestational diabetes (GDM)
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Using Jamar Dynamometer for Grip Strength.Hand grip strength as a marker by using JAMAR hand grip dynamometer in patients with T2DM. | Other | – |
Primary outcome
Comparison of age and gender specific prevalence of sarcopenia using HGS in patients with T2DM
Time frame: 6 days
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 11 Jul 2023.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Anoop Misra, MD principal investigator
Fortis CDOC Hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Type2diabetes, run by Diabetes Foundation, India at 1 site in India.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 11 Jul 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in India. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Anoop Misra, MD (01149101222, anoopmisra@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Comparison of age and gender specific prevalence of sarcopenia using HGS in patients with T2DM (time frame: 6 days). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 11 Jul 2023.