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临床试验/NCT03261362
NCT03261362已完成不适用

Branched-Chain Amino Acid Dietary Reduction Under Weight Maintainance in Overweight Patients With Type 2 Diabetes

German Diabetes Center2 个研究点 分布在 1 个国家目标入组 12 人开始时间: 2016年3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
12
试验地点
2
主要终点
Clamp test

研究概览

简要总结

The purpose of this study is to clarify the role of the branched-chain amino acids in the development of Insulin resistance in patients with diabetes

详细描述

The proposed project aims to elucidate the role of the BCAA in the development of insulin resistance and type 2 diabetes. The project tests the hypothesis that a diet induced decrease of BCAAs concentrations alter the metabolic mechanisms involved in the control insulin resistance and diabetes progression.

The specific aims are to elucidate the effect of the diet induced decrease of BCAAs concentrations on (I) peripheral and hepatic insulin sensitivity (II) ectopic fat distribution (III) energy metabolism (IV) metabolic and inflammatory status

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Crossover
主要目的
Prevention
盲法
Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)

入排标准

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

入选标准

  • Diabetes type 2
  • Non smokers
  • Untrained
  • Willingness to adhere to a diet intervention

排除标准

  • Chronic disease
  • Pregnancy
  • Antibiotic therapy
  • Drug/alcohol abuse
  • Competitive athletes

结局指标

主要结局

Clamp test

时间窗: up to 24 weeks

Insulin sensitivity test

次要结局

  • Mixed Meal Test(up to 24 weeks)

研究者

发起方
German Diabetes Center
申办方类型
Other
责任方
Sponsor

研究点 (2)

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