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临床试验/CTRI/2020/03/024245
CTRI/2020/03/024245尚未招募不适用

Study on Effect of Nutritional Intervention and Exercise to Improve Sarcopenia among Type 2 Diabetic Patients

Prof M Viswanathan Diabetes Research Centre1 个研究点 分布在 1 个国家目标入组 140 人开始时间: 2020年3月30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
140
试验地点
1
主要终点
Improvement in muscle mass

研究概览

简要总结

Sarcopeniais a condition in which progressive loss ofskeletal muscle and muscle function will be present, especially for older population. Literature shows that there is a greater declines in the leg muscle mass andstrength in T2DM patients compared to those without diabetes. Literature shows that supplementation of selected nutrients such asprotein and Vitamin D enhances the body composition and muscle mass. Also, thereare evidence that physical activity can reduce the loss of skeletal muscle and physical inactivity can worsen the condition.

The aim of the study is to see the effect of nutritional intervention and exercise in improving the muscle mass among people with type 2 Diabetes. The patients who are attending the OP of MV hospital for Diabetes, according to the Inclusion & Exclusion criteria, after explaining the study details (Patient Information Sheet) and obtaining the Informed consent (Voluntary involvement) will be screened for Sarcopenia (Grip Strength, Gait Speed and Skeletal Muscle Mass values). The sarcopenia cases will be randomly allocated to the study groups (1 - Protein intake, 2 - Resistance exercise, 3 - Protein intake & resistance exercise, 4 - Control group, The standard care) as per the computer generated randomized numbers. Also, the study participants will be given the appropriate counselling according to the groups allocated. The study participants will be followed up till 6th month and 1 year duration of recruitment. Monthly once, the study participants will be contacted and counselling will be given (Via phone). The same values (Grip Strength, Gait Speed and Skeletal Muscle Mass values) will be assessed during the follow-up and improvement will be measured in each group & compared.

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
30.00 Year(s) 至 80.00 Year(s)(—)
性别
All

入选标准

  • K/C/O T2DM, above 30 years of age, with low muscle mass (lean). Type 2 diabetes above 30 years of age. Duration of Diabetes.
  • within 5 years. People with low muscle mass and low muscle strength. Patients attending OP clinic of MV hospital for Diabetes, Royapuram will be included (especially those who come from Chennai or nearby district). Patients who are voluntarily willing to provide Informed consent.

排除标准

  • People with normal muscle mass and muscle strength.
  • People with any cognitive impairment are excluded from exercise intervention group.
  • People with any Kidney diseases are excluded.
  • Pregnant and lactating women are excluded.
  • Patients who are in the insulin treatment and who taking SGLT2 inhibitors are excluded.

结局指标

主要结局

Improvement in muscle mass

时间窗: 6th and 12th months

次要结局

  • To determine and compare the results within the intervention groups.(12th month)

研究者

发起方
Prof M Viswanathan Diabetes Research Centre
申办方类型
Research institution

研究点 (1)

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