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临床试验/CTRI/2026/03/106913
CTRI/2026/03/106913尚未招募不适用

Prevalence of Sarcopenia in young adults with newly diagnosed type 2 Diabetes and the influence of initial treatment on body composition and muscle health. A hospital based prospective cohort study

All India Institute of Medical Sciences, Rajkot, Gujarat1 个研究点 分布在 1 个国家目标入组 122 人开始时间: 2026年4月6日最近更新:
适应症

试验速览

阶段
不适用
状态
尚未招募
发起方
入组人数
122
试验地点
1
主要终点
change in skeletal muscle mass and segmental lean mass from baseline to 6 months, measured using InBody 770, Dynamometer in newly diagnosed Diabetes mellitus, Also calculate the prevalence of sarcopenia.

研究概览

简要总结

My study is a prospective observational study which aims to evaluate changes in skeletal muscle mass and body composition in patients with newly diagnosed type 2 diabetes mellitus over a period of 6 months. Sarcopenia is increasingly recognized as an important comorbidity in patients with diabetes mellitus and is associated with poor glycemic control and adverse clinical outcomes. Young adults patients(upto 40 yrs) with type 2 diabetes mellitus attending medicine opd of aiims rajkot will be included. baseline assessment will include measurement of skeletal muscle mass, phase angle, and other body composition parameters using bioelectrical impedence analysis(InBody 770). glycemic control will be assessed using HbA1c levels, and functional assessment will include handgrip strength and gait speed. participants will be followed up at 6 months, and changes in muscle mass, body composition parameters, and phase angle will be reassessed. the study will also evaluate prevalence and severity of sarcopenia and its association with glycemic control. findings may help in early identification and management of sarcopenia in patients with type 2 diabetes mellitus and improvement in muscle mass will also decrease in insulin resistance leading to overall better outcome.

研究设计

研究类型
Observational

入排标准

年龄范围
18.00 Year(s) 至 40.00 Year(s)(—)
性别
All

入选标准

  • Adults aged less than 40 years, newly diagnosed with type 2 Diabetes (HbA1c equal or more than 6.5% or fasting glucose equal or more than 126 mg/dL), no prior diabetes treatment or minimal treatment (less than 1 month), and willing to undergo body composition analysis.

排除标准

  • Type 1 diabetes, secondary diabetes, severe comorbidities(like cancer, end-stage renal disease), pregnancy, conditions contraindicating body composition testing or who require insulin therapy.

结局指标

主要结局

change in skeletal muscle mass and segmental lean mass from baseline to 6 months, measured using InBody 770, Dynamometer in newly diagnosed Diabetes mellitus, Also calculate the prevalence of sarcopenia.

时间窗: Baseline(0 month) and at end of study(6 month)

次要结局

  • Association between changes in skeletal muscle mass and glycemic control(HbA1c) over 6 month. prevalence and severity of sarcopenia at baseline and 6 months(using muscle mass, handgrip strength and gait speed). change in phase angle from baseline to 6 months. Change in body composition parameters(body fat%, visceral fat, extracellular water ratio) from baseline to 6 months.(Baseline(0 month) and at end of study(6 month))

研究者

发起方
All India Institute of Medical Sciences, Rajkot, Gujarat
申办方类型
Government medical college
责任方
Principal Investigator
主要研究者

Priyank kumar singh

All india institute of medical sciences, rajkot, gujarat

研究点 (1)

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