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临床试验/CTRI/2019/01/016824
CTRI/2019/01/016824尚未招募不适用

“THE STUDY TO EVALUATE THE SUBCLINICAL LOWER EXTREMITY MUSCLE STRENGTH DECREASE IN DIABETIC INDIVIDUAL AND COMPARING WITH AGE MATCHED HEALTHY SUBJECTS INFLUENCING QUALITY OF LIFEâ€.

Meenatchi N1 个研究点 分布在 1 个国家目标入组 100 人开始时间: 2019年2月1日最近更新:

试验速览

阶段
不适用
状态
尚未招募
发起方
入组人数
100
试验地点
1
主要终点
muscle strength evaluation for diabetic and comparing with normative healthy subjects -hand held dynamometer

研究概览

简要总结

Diabetes mellitus is a chronic metabolicdisease, characterized by hyperglycemia resulting in insulin secretiondeficits, insulin action or both and highly glycated hemoglobin, higher inelderly than in younger population. Generally skeletal muscle tissue isresponsible for 40% of body weight and considered as major site of insulinmediated glucose uptake, which accounts approximately 75% of whole body insulinstimulated glucose uptake  Therefore decrease inmuscle strength especially in lower limbs is depicted by the insulinresistance, metabolic inflexibility and neuro muscular impairments.Earlier studies have stated that Diabetes mellitus isassociated with loss of muscle strength in distal extremity of lower limb. There is a growing evidences which shows thecomplication of type 2 diabetes may translate into the functional impairment inolder people, this might link the metabolic and mechanical function of the muscle

Henceforth theevaluation of the lower extremity muscle strength can be assessed by hand helddynamometer, for knee extensors, ankle dorsiflexors, plantar flexors, in bothdiabetic and age matched healthy individuals, and to identify the impact ofthese muscles with sit to stand lower extremity functional strength and consideringthe variables like duration of diabetes, glycemic control, HbA1C values.

Boththe group will be evaluated with five repetitionsit to stand test (FRSTST), to screen their lower extremity functional strength,and quality of life measure done through generic health related quality of lifemeasure SF -36 Questionnaire

The main objective of this study is to determinewhether a clinical scenario might exist where there will be a subclinical musclepower decrease without any reflections on functions performed in diabetic individualswhen compared with age matched healthy individuals.

研究设计

研究类型
Observational

入排标准

年龄范围
50.00 Year(s) 至 60.00 Year(s)(—)
性别
All

入选标准

  • Patient with type 2 DM with known duration and glycemic level and HbA1C levels (if available) Cooperative and able to understand instruction.
  • Able to walk independently for 10metres, unaided.

排除标准

  • Cardiac and renal insufficiencies muscular disorders/rheumatoid arthritis foot ulcers/foot amputations difficulty to perform activities of daily living use of cane or any other equipment to get around any neurological impairments.

结局指标

主要结局

muscle strength evaluation for diabetic and comparing with normative healthy subjects -hand held dynamometer

时间窗: With instruction of push hold for 3 sec and relax, for three join movements- knee extensors,ankle dorsiflexors and plantar flexors

次要结局

  • HbA1C levels, fasting and post prandial blood levels, age, BMI, gender(assessed during data analysis)

研究者

发起方
Meenatchi N
申办方类型
Other [self]

研究点 (1)

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