Clinical trial NCT05939908: Assessment of Hand Grip Strength Using Jamar Dynamometer
Official title: To Assess Prevalence of Sarcopenia Using Hand Grip Strength (HGS) as a Marker in Patients With T2DM
Study type: OBSERVATIONAL
Overall status: RECRUITING
Conditions: Type2diabetes
Lead sponsor: Diabetes Foundation, India
Sponsor class: OTHER
Collaborators: name: National Diabetes Obesity and Cholesterol Foundation
First posted: 2023-07-11
Enrollment: 5000
Sex: ALL
Minimum age (years): 20
Maximum age (years): 60
Standard ages: ADULT
Accepts healthy volunteers: yes
Observational model: OTHER
Time perspective: OTHER
Sampling method: NON_PROBABILITY_SAMPLE
Study population: T2DM patient visiting Fortis CDOC Hospital and meeting the Inclusion Criteria will be enrolled in the study.

Brief 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. 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.

Eligibility criteria: Inclusion Criteria:

All patients with Type 2 diabetes of any duration coming for first time in OPD

Exclusion Criteria:

1. Patients with hand fracture
2. Thyroid dysfunction
3. Any musculoskeletal condition causing difficulty in holding the dynamometer
4. Patients with type1 diabetes (T1DM) and gestational diabetes (GDM)

Primary outcomes:
measure: Comparison of age and gender specific prevalence of sarcopenia using HGS in patients with T2DM
timeFrame: 6 days
Secondary outcomes:
Other outcomes:
Locations:
city: Delhi
country: India
facility: Fortis CDOC Hospital
Study officials:
affiliation: Fortis CDOC Hospital
name: Anoop Misra, MD
role: PRINCIPAL_INVESTIGATOR
References: