Effects of Metformin in Pre-frail Elderly

Study Overview
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Brief Summary
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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.

Official Title
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Randomized-Controlled Trial of Metformin to Prevent Frailty in Pre-frail Elderly

Conditions
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Pre-frail Elderly

Intervention / Treatment
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* Drug: Metformin
* Drug: Placebo


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Pre-frail elderly; Capable to understand and carry-out the instruction. Exclusion Criteria: 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.

Ages Eligible for Study
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Minimum Age: 60 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Metformin<br>Metformin tablet 500 mg three times a day for 16 weeks. | Drug: Metformin<br>* Metformin tablet 500 mg three times a day for 16 weeks. If there is no significant outcome obtained between two arms in 16 weeks, metformin will continue until 24 weeks.<br>* Other names: ATC Code: A10BA02;|
| Placebo Comparator: Placebo<br>Placebo tablet three times a day for 16 weeks. | Drug: Placebo<br>* Placebo three times a day for 16 weeks. If there is no significant outcome obtained between two arms in 16 weeks, placebo will continue until 24 weeks.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change from baseline in frailty status at 16 weeks | Measurement: Frailty Index 40 items | Baseline and at 16 weeks | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change from baseline in health-related quality of life (HrQoL) at 16 weeks | Measurement: EQ-5D (with permission) | Baseline and at 16 weeks | 
| Change from baseline in handgrip strength at 16 weeks | Measurement: handgrip dynamometer (Jamar Hydraulic Hand Dynamometer Model J00105) | Baseline and at 16 weeks | 
| Change from baseline in gait speed at 16 weeks | Measurement: 15-feet walking test | Baseline and at 16 weeks | 
| Change from baseline in serum myostatin levels at 16 weeks | Measurement: ELISA test | Baseline and at 16 weeks | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Frailty, Pre-frailty, Metformin, Elderly, Quality of life, Handgrip, Gait speed, Myostatin