Pre-frail Elderly
Conditions
Keywords
Frailty, Pre-frailty, Metformin, Elderly, Quality of life, Handgrip, Gait speed, Myostatin
Brief summary
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.
Interventions
DRUGMetformin
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.
DRUGPlacebo
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.
Sponsors
Indonesia University
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
QUADRUPLE (Subject, Caregiver, Investigator, Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
60 Years to No maximum
Healthy volunteers
No
Inclusion criteria
1. Pre-frail elderly; 2. Capable to understand and carry-out the instruction.
Exclusion criteria
1. Unwilling to join the study; 2. Diabetes mellitus (oral glucose tolerance test); 3. Abbreviated Mental Test (AMT) score \< 8; 4. Geriatric Depression Scale (GDS) score \>= 10; 5. Body mass index (BMI) \<18,5 Kg/m2; 6. Malnutrition (according to Mini Nutritional Assessment/MNA); 7. Liver cirrhosis, severe liver dysfunction, or serum ALT levels \>3 times upper normal limit; 8. Acute illness during inclusion period, eg. pneumonia, pain due to acute arthritis (visual analog scale \>6/10), stroke attack, crisis hypertension; 9. Severe cardiac dysfunction: acute decompensated heart failure and/or chronic heart failure functional class III or IV (New York Heart Association classification); 10. Severe pulmonary dysfunction: acute exacerbation of chronic obstructive lung disease stage III or IV (GOLD classification), and/or PaO2 levels \< 60 mmHg; 11. Allergy to metformin.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Change from baseline in frailty status at 16 weeks | Baseline and at 16 weeks | Measurement: Frailty Index 40 items |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Change from baseline in health-related quality of life (HrQoL) at 16 weeks | Baseline and at 16 weeks | Measurement: EQ-5D (with permission) |
| Change from baseline in handgrip strength at 16 weeks | Baseline and at 16 weeks | Measurement: handgrip dynamometer (Jamar Hydraulic Hand Dynamometer Model J00105) |
| Change from baseline in gait speed at 16 weeks | Baseline and at 16 weeks | Measurement: 15-feet walking test |
| Change from baseline in serum myostatin levels at 16 weeks | Baseline and at 16 weeks | Measurement: ELISA test |
Countries
Indonesia
Outcome results
None listed