Can metformin prevent worsening of muscle weakness and frailty in older people who are showing early signs of frailty?

Phase 4

Completed

• Conditions: Frailty and sarcopenia in older people; Signs and Symptoms

• Registration Number: ISRCTN29932357
• Lead Sponsor: ewcastle upon Tyne Hospitals NHS Foundation Trust

Brief Summary

2022 Protocol article in https://pubmed.ncbi.nlm.nih.gov/35851031/ (added 18/08/2023)

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2021-01-21
• Study Completion: 2023-08-31
• Last Update Posted: 5 February 2024

Recruitment & Eligibility

• Status: Completed
• Sex: All
• Target Recruitment: 72

Inclusion Criteria

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

Exclusion Criteria

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)

Study & Design

• Study Type: Interventional
• Study Design: Not specified