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临床试验/NCT02984605
NCT02984605Unknown不适用

Effects of Nutrition Meal Replacement and Individualized Exercise Prescription on Metabolism in Overweight and Obese Type 2 Diabetes

Xinhua Hospital, Shanghai Jiao Tong University School of Medicine0 个研究点目标入组 200 人开始时间: 2016年12月最近更新:
适应症

试验速览

阶段
不适用
入组人数
200
主要终点
glycated hemoglobin

研究概览

简要总结

This study evaluates the nutritional meal replacement and individualized exercise prescription intervention on overweight and obese type 2 diabetes mellitus. Half of participants will receive nutritional meal replacement and individualized exercise prescription on the basis of conventional glucose-lowering treatment, while the other half will only receive conventional glucose-lowering treatment.

详细描述

Diabetes mellitus is a chronic metabolic disease which seriously threatens people's health at present. Although new drugs for the treatment of diabetes continue to emerge, but the effect of diabetes treatment is still not satisfactory. Medical nutrition therapy (nutrition therapy medical, MNT) and exercise therapy are essential measures for prevention and control of diabetes at any stage of the natural course of the disease, especially for the overweight and obese patients with type 2 diabetes. However, at present, the majority of patients could not get the guide from nutrition specialist and sports specialist. In addition, the existing diet programs are often more complex, difficult to implement and adhere to in daily life, and exercise programs are often lack of targeted. In view of this, the Shanghai peak Sports Management Co., Ltd. developed a kind of nutritional meal replacement for weight loss. The nutritional powder has the characteristics of high nutrition, low calorie, low glycemic and strong satiety, and the heat is only 126kcal, and have a good sense of satiety. Studies have shown that 1 times a day with bags of nutritional meal replacement instead of 1 meals for obese people have a role in weight loss. In theory, the meal is also suitable for diabetes patients, especially overweight and obese type 2 diabetes, such as the combination of individual exercise prescription may be better, but there is still a lack of relevant research. In view of this, we proposed a joint sports workers, explore nutritional and individualized exercise prescription intervention on overweight and obese type 2 diabetes mellitus, to explore suitable for China's diabetes lifestyle intervention measures, improve the level of prevention and treatment of diabetes in China.

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
None

入排标准

性别
All
接受健康志愿者

入选标准

  • Clinical diagnosis of overweight and obesity type 2 diabetes
  • Must be able to swallow tablets

排除标准

  • Insulin dependent diabetes
  • Thyroid disease

结局指标

主要结局

glycated hemoglobin

时间窗: 24 weeks

次要结局

未报告次要终点

研究者

申办方类型
Other
责任方
Sponsor

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