Effects of Metformin in Pre-frail Elderly

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Clinical Phase

PHASE3

Total Enrollment

150 participants

Study Classification

INTERVENTIONAL

Study Start Date

2015-03-31

Study Completion Date

2017-03-31

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.

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Detailed Description

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Conditions

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Pre-frail Elderly

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

QUADRUPLE

Participants Caregivers Investigators Outcome Assessors

Study Groups

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Metformin

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

Group Type EXPERIMENTAL

Metformin

Intervention Type DRUG

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.

Placebo

Placebo tablet three times a day for 16 weeks.

Group Type PLACEBO_COMPARATOR

Placebo

Intervention Type DRUG

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.

Interventions

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Metformin

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.

Intervention Type DRUG

Placebo

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.

Intervention Type DRUG

Other Intervention Names

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CAS Number: 657-24-9 ATC Code: A10BA02

Eligibility Criteria

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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.

Minimum Eligible Age

60 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No