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临床试验/CTRI/2022/04/042186
CTRI/2022/04/042186招募中不适用

Randomized controlled trial to compare the effect of dietary intervention and resistance exercises on changes in skeletal muscle strength, mass and function in Type 2 Diabetes patients with Dynapenia and Sarcopenia

INDIAN COUNCIL OF MEDICAL RESEARCH1 个研究点 分布在 1 个国家目标入组 150 人开始时间: 2022年2月5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
150
试验地点
1
主要终点
muscle strength, muscle mass and muscle function, biochemical parameters, body composition

研究概览

简要总结

a.    Background: Sarcopenia describesdeclines in muscle mass and strength and has been implicated as both a causeand consequence of T2DM. T2DM is characterized by insulin resistance, increasedadvanced glycation end products (AGEs), a proinflammatory phenotype andoxidative stress, which can lead to micro- and macro-vascular complications whichmay lead to losses in skeletal muscle mass, strength, and function, potentiallyleading to the development of dynapenia and sarcopenia

b.    Novelty: this is a first intervention which includesdietary and resistant exercise for management of dynapenia/sarcopenia in type 2diabetes subjects on Indian population.

c.     **Objectives:**Tocompare the effect of dietary intervention (DI) with resistance exercise (RE)verses standard diet (SD) and standard exercise (SE) and in other arm effect ofdietary intervention (DI) with standard exercise (SE) verses standard diet (SD)and resistance exercise (SE) on skeletal muscle mass and function and physicalperformance in type 2 diabetes subjects with Dynapenia or sarcopenia. Glycemia,lipids profile, insulin sensitivity and subclinical inflammation, adherence tothe intervention will also be compared in each group.

d.    Methods: The study is a 3-armed randomized controlled trialwhere combination of dietary intervention, resistance exercise and standarddiet and standard exercise will be compared. Total 150 subjects will berecruited with 50 subjects in each arm.

***e.***Expected outcome: Acombination of dietary intervention along with resistance exercises is likelyto result in improved muscle mass and function in sarcopenic individuals. Thisin turn will be helpful in improving metabolic abnormalities such as insulinresistance, dyslipidemia and dysglycemia.

研究设计

研究类型
Interventional
分配方式
Computer generated randomization
盲法
Open Label

入排标准

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

入选标准

  • •ï‚¢Patients age between 18-60yrs.
  • •ï‚¢Patients diagnosed with Type -2 DM.
  • •Along with Sarcopenic ï‚¢Hand grip strength Men <28 kg, Women <18 kg ï‚¢Appendicular skeletal muscle mass/height2: Men<7.0kg/m2, Women <5.4 kg/m
  • •ï‚¢SPPB≤8 (The maximum score on the SPPB is:12) ï‚¢4-minute gait speed <0.8m/s.

排除标准

  • •ï‚¢Patient with concomitant severe heart, liver or renal diseases.
  • •ï‚¢Pregnancy and Lactation, and any physical deformity or loss of extremity.
  • •ï‚¢HIV, HbsAg and HCV positive patients.

结局指标

主要结局

muscle strength, muscle mass and muscle function, biochemical parameters, body composition

时间窗: At baseline 6 weeks and 12 weeks

次要结局

  • Anthropometric measures and Biomarkers(Baseline and 12 weeks)

研究者

申办方类型
Other [GOVERNMENT OF INDIA]

研究点 (1)

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