NCT02325245Unknown3 期
Randomized-Controlled Trial of Metformin to Prevent Frailty in Pre-frail Elderly
适应症
干预措施
相关药物
试验速览
- 阶段
- 3 期
- 入组人数
- 150
- 试验地点
- 1
- 主要终点
- Change from baseline in frailty status at 16 weeks
研究概览
简要总结
The purpose of this study is to investigate the effects of metformin to prevent frailty in pre-frail non-diabetic elderly. Several outcomes measured in this study are frailty status, quality of life, handgrip strength, gait speed, and serum myostatin levels.
We hypothesize that metformin for 16 weeks could prevent frailty in pre-frail elderly.
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)
入排标准
- 年龄范围
- 60 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Pre-frail elderly;
- •Capable to understand and carry-out the instruction.
排除标准
- •Unwilling to join the study;
- •Diabetes mellitus (oral glucose tolerance test);
- •Abbreviated Mental Test (AMT) score < 8;
- •Geriatric Depression Scale (GDS) score >= 10;
- •Body mass index (BMI) <18,5 Kg/m2;
- •Malnutrition (according to Mini Nutritional Assessment/MNA);
- •Liver cirrhosis, severe liver dysfunction, or serum ALT levels >3 times upper normal limit;
- •Acute illness during inclusion period, eg. pneumonia, pain due to acute arthritis (visual analog scale >6/10), stroke attack, crisis hypertension;
- •Severe cardiac dysfunction: acute decompensated heart failure and/or chronic heart failure functional class III or IV (New York Heart Association classification);
- •Severe pulmonary dysfunction: acute exacerbation of chronic obstructive lung disease stage III or IV (GOLD classification), and/or PaO2 levels < 60 mmHg;
- •Allergy to metformin.
研究组 & 干预措施
Metformin
Experimental
Metformin tablet 500 mg three times a day for 16 weeks.
干预措施: Metformin (Drug)
Placebo
Placebo Comparator
Placebo tablet three times a day for 16 weeks.
干预措施: Placebo (Drug)
结局指标
主要结局
Change from baseline in frailty status at 16 weeks
时间窗: Baseline and at 16 weeks
Measurement: Frailty Index 40 items
次要结局
- Change from baseline in serum myostatin levels at 16 weeks(Baseline and at 16 weeks)
- Change from baseline in gait speed at 16 weeks(Baseline and at 16 weeks)
- Change from baseline in handgrip strength at 16 weeks(Baseline and at 16 weeks)
- Change from baseline in health-related quality of life (HrQoL) at 16 weeks(Baseline and at 16 weeks)
研究者
Purwita Wijaya Laksmi
Purwita Wijaya Laksmi, MD, SpPD-KGer
Indonesia University
研究点 (1)
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