Effects of Metformin in Pre-frail Elderly

• Status: Unknown status
• Trial end date: 2017-03-01
• Target enrollment: 0
• Participant gender: All

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.

• Phase: Phase 3
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Indonesia University
• Treatments: Metformin

Criteria

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.