ISRCTN29932357已完成4 期
Metformin to prevent progression of sarcopenia and frailty for older people – a randomised controlled proof of concept trial
ewcastle upon Tyne Hospitals NHS Foundation Trust0 个研究点目标入组 72 人开始时间: 2021年1月21日最近更新:
适应症
试验速览
- 阶段
- 4 期
- 状态
- 已完成
- 发起方
- 入组人数
- 72
研究概览
简要总结
2022 Protocol article in https://pubmed.ncbi.nlm.nih.gov/35851031/ (added 18/08/2023)
研究设计
- 研究类型
- Interventional
入排标准
- 性别
- All
入选标准
- •1. Aged 65 years or over
- •2. Low maximum handgrip strength (<16 kg for women, <27 kg for men)
- •3. Walk speed <0.8 m/s on 4-m walk test
排除标准
- •1. Diabetes mellitus (type 1 or type 2)
- •2. eGFR <45 ml/min/1.73 m2 by MDRD4 or CKD-EPI equation
- •3. History of diarrhoeal illness within the last 3 months (>48 h of Bristol stool chart grade 6 or 7 )
- •4. Alcohol intake >21 units/week (women) or >35 units/week (men)
- •5. Symptomatic chronic heart failure, diagnosed according to European Society of Cardiology guidelines (asymptomatic left ventricular systolic dysfunction will not be an exclusion criterion)
- •6. Liver function tests (bilirubin, alanine aminotransferase or alkaline phosphatase) >3x upper limit of normal
- •7. Oral steroid dose >7.5 mg prednisolone equivalent per day
- •8. Unable to mobilise without human assistance
- •9. Life expectancy of <3 months as adjudicated by the local investigator
- •10. Unable to give written informed consent
- •11. Previous intolerance of metformin or taking metformin for another condition
- •12. Currently participating in, or participated within 30 days, another intervention study (observational studies and registries are permitted)
研究者
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