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临床试验/NCT05939908
NCT05939908招募中不适用

To Assess Prevalence of Sarcopenia Using Hand Grip Strength (HGS) as a Marker in Patients With T2DM

Diabetes Foundation, India1 个研究点 分布在 1 个国家目标入组 5,000 人开始时间: 2023年7月1日最近更新:
适应症

试验速览

阶段
不适用
状态
招募中
入组人数
5,000
试验地点
1
主要终点
Comparison of age and gender specific prevalence of sarcopenia using HGS in patients with T2DM

研究概览

简要总结

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.

详细描述

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.

研究设计

研究类型
Observational
观察模型
Other
时间视角
Other

入排标准

年龄范围
20 Years 至 60 Years(Adult)
性别
All
接受健康志愿者

入选标准

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

排除标准

  • Patients with hand fracture
  • Thyroid dysfunction
  • Any musculoskeletal condition causing difficulty in holding the dynamometer
  • Patients with type1 diabetes (T1DM) and gestational diabetes (GDM)

结局指标

主要结局

Comparison of age and gender specific prevalence of sarcopenia using HGS in patients with T2DM

时间窗: 6 days

次要结局

未报告次要终点

研究者

申办方类型
Other
责任方
Principal Investigator
主要研究者

Dr Anoop Misra

Director

Diabetes Foundation, India

研究点 (1)

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