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临床试验/NCT05375630
NCT05375630招募中不适用

Effects Vitamin K2 on Muscle Mass and Function in People With Muscle Weakness and Type 2 Diabetes

Dasman Diabetes Institute2 个研究点 分布在 1 个国家目标入组 150 人开始时间: 2022年3月21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
2
主要终点
Grip Strength

研究概览

简要总结

The aim of the current study is to determine the effects of vitamin K2 supplementation on muscle size and function in adults with muscle weakness and type 2 diabetes.

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
Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)

盲法说明

Double blind

入排标准

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

入选标准

  • Physician confirmed type 2 diabetes.
  • Age >/= 40 years
  • No changes in anti-diabetic medication in the last 3 months.
  • Muscle weakness (grip strength <27kg and females <16kg)

排除标准

  • BMI of 45 or higher
  • BP of 160/100mmHg or higher
  • Cancer or cancer that has been in remission <5 years
  • Any medical condition that prevents participants from exercising safely
  • On anticoagulant therapy
  • Currently consuming vitamin K2 supplements
  • Current smoker

结局指标

主要结局

Grip Strength

时间窗: Baseline to one year

Change in Grip Strength

次要结局

  • BMD(Baseline to one year)
  • Blood Pressure(Baseline to one year)
  • Lean Mass(Baseline to one year)
  • HbA1c(Baseline to one year)
  • Body Fat(Baseline to one year)
  • Vitamin K status(Baseline to one year)
  • BMC(Baseline to one year)
  • Body Mass(Baseline to one year)
  • SPPB(Baseline to one year)

研究者

申办方类型
Other
责任方
Principal Investigator
主要研究者

Dr. Ebaa Al Ozairi

Chief Medical Officer

Dasman Diabetes Institute

研究点 (2)

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