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临床试验/NCT06391983
NCT06391983已完成不适用

Effect of Resistance Training on Intermuscular Adipose Tissue in Patients With Type 2 Diabetes

Lou Qingqing1 个研究点 分布在 1 个国家目标入组 85 人开始时间: 2021年7月1日最近更新:
适应症

试验速览

阶段
不适用
状态
已完成
发起方
入组人数
85
试验地点
1
主要终点
The primary outcome were the changes of IMAT

研究概览

简要总结

Data shows that high intensity resistance training reduces Intermuscular Adipose Tissue (IMAT) in obesity adults. Whether moderate resistance training reduces IMAT for non-obese elderly patients with diabetes is not clear. Therefore, this study aimed to evaluate the impact of moderate resistance training on IMAT in elderly patients with type 2 diabetes, and the independent effect of IMAT reduction on metabolic outcomes.

In this randomized control trial (RCT), 85 type 2 diabetes patients were randomized into the resistance training group (42 participants) and control group (43 participants) for 6-month intervention. The control group was not asked to participate in any regular exercise. However, the group attended online group educational sessions about diabetes self management once a month, and were asked to record their daily physical activities. Online mini program Wechat was used for communication. The intervention group attended online group education sessions on diabetes self management as the control group, as well as resistance exercise training sessions three times weekly; the sessions were approximately 40 minutes long and included 5 minutes of warm up, followed by 30 minutes of resistance exercises and 5 minutes of cool down. The resistance training consisted of ten upper-body and lower-body exercises using elastic band. The initial sessions were 1 to 2 sets of 6 to 8 repetitions at 45% of the one-repetition maximum (1 RM). It was increased progressively to 2 to 3 sets of 8 to 12 repetitions at approximately 50% -55% of 1 RM. The primary outcome were the changes of IMAT measured by computed tomography(CT)scan and magnetic resonance imaging (MRI) interactive decomposition of water and fat with echo asymmetry and least squares qualification sequence (IDEAL-IQ). The secondary outcomes were the changes in metabolic parameters.

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Parallel
主要目的
Treatment
盲法
Single (Outcomes Assessor)

入排标准

年龄范围
60 Years 至 75 Years(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • Type 2 diabetes
  • ≥60 and <75 years of age
  • Normal muscle strength
  • Body-mass index (BMI) ≤35
  • Glycosylated hemoglobin A1c (HbA1c) < 9%

排除标准

  • Patients who had severe chronic diabetes complications(e.g., stroke, myocardial infarction, end stage renal disease, proliferative retinopathy)
  • Cognitive impairments

结局指标

主要结局

The primary outcome were the changes of IMAT

时间窗: 6 months

MRI IDEAL-IQ was used to quantitatively assess IMAT in the middle of left thigh. This study used fat fraction as the indicator to quantify IMAT of the thigh muscle. CT scan was used to assess IMAT area. Hounsfeild (Hu) was used to quantify the density of muscle or fat. The density of IMAT area is low, between -190Hu to -30Hu. With regard to muscle area, there are two different density areas: Normal attenuation muscle area, with density between 31Hu to 100Hu, representing normal muscle area, and Low attenuation muscle area, with density between 0Hu to 30Hu, representing fat infiltration, the lower the Hu, the higher the fat infiltration.

次要结局

未报告次要终点

研究者

发起方
Lou Qingqing
申办方类型
Other Gov
责任方
Sponsor Investigator
主要研究者

Lou Qingqing

M.D. Director,Hainan Clinical Medical Research Center for Metabolic Disease

The First Affiliated Hospital of Hainan Medical University

研究点 (1)

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