Effects of Metformin in Pre-frail Elderly

University of Indonesia (UI)

Status and phase: Unknown; Phase 3

Conditions: Pre-frail Elderly

Treatments: Drug: Metformin; Drug: Placebo

Study type: Interventional

Funder types: Other

Identifiers

NCT02325245

FRAIL-01

Details and patient eligibility

About

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.

Enrollment: 150 estimated patients

Sex: All

Ages: 60+ years old

Volunteers: No Healthy Volunteers

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.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Quadruple Blind

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150 participants in 2 patient groups, including a placebo group

Metformin

Experimental group

Description:

Metformin tablet 500 mg three times a day for 16 weeks.

Treatment:

Drug: Metformin

Placebo

Placebo Comparator group

Description:

Placebo tablet three times a day for 16 weeks.

Treatment:

Drug: Placebo