Effects of Metformin in Pre-frail Elderly
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ClinicalTrials.gov Identifier: NCT02325245 |
Recruitment Status : Unknown
Verified September 2016 by Purwita Wijaya Laksmi, Indonesia University.
Recruitment status was: Recruiting
First Posted : December 24, 2014
Last Update Posted : September 14, 2016
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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.
Condition or disease | Intervention/treatment | Phase |
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Pre-frail Elderly | Drug: Metformin Drug: Placebo | Phase 3 |
Study Type : | Interventional (Clinical Trial) |
Estimated Enrollment : | 150 participants |
Allocation: | Randomized |
Intervention Model: | Parallel Assignment |
Masking: | Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor) |
Primary Purpose: | Treatment |
Official Title: | Randomized-Controlled Trial of Metformin to Prevent Frailty in Pre-frail Elderly |
Study Start Date : | March 2015 |
Estimated Primary Completion Date : | December 2016 |
Estimated Study Completion Date : | March 2017 |

Arm | Intervention/treatment |
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Experimental: Metformin
Metformin tablet 500 mg three times a day for 16 weeks.
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Drug: 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.
Other Names:
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Placebo Comparator: Placebo
Placebo tablet three times a day for 16 weeks.
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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. |
- Change from baseline in frailty status at 16 weeks [ Time Frame: Baseline and at 16 weeks ]Measurement: Frailty Index 40 items
- Change from baseline in health-related quality of life (HrQoL) at 16 weeks [ Time Frame: Baseline and at 16 weeks ]Measurement: EQ-5D (with permission)
- Change from baseline in handgrip strength at 16 weeks [ Time Frame: Baseline and at 16 weeks ]Measurement: handgrip dynamometer (Jamar Hydraulic Hand Dynamometer Model J00105)
- Change from baseline in gait speed at 16 weeks [ Time Frame: Baseline and at 16 weeks ]Measurement: 15-feet walking test
- Change from baseline in serum myostatin levels at 16 weeks [ Time Frame: Baseline and at 16 weeks ]Measurement: ELISA test

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Ages Eligible for Study: | 60 Years and older (Adult, Older Adult) |
Sexes Eligible for Study: | All |
Accepts Healthy Volunteers: | No |
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.

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02325245
Indonesia | |
Cipto Mangunkusumo General Hospital | Recruiting |
Central Jakarta, Jakarta, Indonesia, 10430 | |
Contact: Purwita Laksmi, MD +62-21-3918301 pwlaksmi@yahoo.com |
Principal Investigator: | Purwita Laksmi, MD,SpPD-KGer | Division of Geriatrics, Department of Internal Medicine, Universitas Indonesia-Cipto Mangunkusumo General Hospital, Jakarta |
Responsible Party: | Purwita Wijaya Laksmi, Purwita Wijaya Laksmi, MD, SpPD-KGer, Indonesia University |
ClinicalTrials.gov Identifier: | NCT02325245 |
Other Study ID Numbers: |
FRAIL-01 |
First Posted: | December 24, 2014 Key Record Dates |
Last Update Posted: | September 14, 2016 |
Last Verified: | September 2016 |
Individual Participant Data (IPD) Sharing Statement: | |
Plan to Share IPD: | Yes |
Frailty Pre-frailty Metformin Elderly |
Quality of life Handgrip Gait speed Myostatin |
Frailty Pathologic Processes Metformin Hypoglycemic Agents Physiological Effects of Drugs |