NCT05375630招募中不适用
Effects Vitamin K2 on Muscle Mass and Function in People With Muscle Weakness and Type 2 Diabetes
适应症
干预措施
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 150
- 试验地点
- 1
- 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
- 否
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
研究组 & 干预措施
Placebo
Placebo Comparator
micro-crystalline cellulose placebo (one 380 mg tablet per day)
干预措施: Placebo (Dietary Supplement)
Vitamin K2
Active Comparator
micro-crystalline cellulose (one 380 mg tablet per day) where vitamin K2 (K2VITAL® 0.2% DELTA powder) is mixed into the formulation to a final vitamin K2 concentration of 240 μg/tablet
干预措施: Vitamin K2 (Dietary Supplement)
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
- HbA1c(Baseline to one year)
- Vitamin K status(Baseline to one year)
- Lean Mass(Baseline to one year)
- BMD(Baseline to one year)
- Body Fat(Baseline to one year)
- Blood Pressure(Baseline to one year)
- BMC(Baseline to one year)
- Body Mass(Baseline to one year)
- SPPB(Baseline to one year)
研究者
Dr. Ebaa Al Ozairi
Chief Medical Officer
Dasman Diabetes Institute
研究点 (1)
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