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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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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Metformin | Experimental | Metformin tablet 500 mg three times a day for 16 weeks. |
|
| Placebo | Placebo Comparator | Placebo tablet three times a day for 16 weeks. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Metformin | 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. |
| Measure | Description | Time Frame |
|---|---|---|
| Change from baseline in frailty status at 16 weeks | Measurement: Frailty Index 40 items | Baseline and at 16 weeks |
| Measure | Description | Time Frame |
|---|---|---|
| Change from baseline in health-related quality of life (HrQoL) at 16 weeks | Measurement: EQ-5D (with permission) | Baseline and at 16 weeks |
| Change from baseline in handgrip strength at 16 weeks |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Purwita Laksmi, MD,SpPD-KGer | Division of Geriatrics, Department of Internal Medicine, Universitas Indonesia-Cipto Mangunkusumo General Hospital, Jakarta | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Cipto Mangunkusumo General Hospital | Recruiting | Central Jakarta | Jakarta Special Capital Region | 10430 | Indonesia |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 25348180 | Background | Sumantri S, Setiati S, Purnamasari D, Dewiasty E. Relationship between metformin and frailty syndrome in elderly people with type 2 diabetes. Acta Med Indones. 2014 Jul;46(3):183-8. | |
| 25506599 | Background | Wang CP, Lorenzo C, Espinoza SE. Frailty Attenuates the Impact of Metformin on Reducing Mortality in Older Adults with Type 2 Diabetes. J Endocrinol Diabetes Obes. 2014;2(2):1031. |
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| Type | Date | Date Unknown |
|---|---|---|
| Release | Aug 27, 2017 | |
| Reset | Mar 22, 2018 |
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| Release Date | Unrelease Date | Unrelease Date Unknown | Reset Date | MCP Release Number |
|---|---|---|---|---|
| Aug 27, 2017 | Mar 22, 2018 |
| ID | Term |
|---|---|
| D000073496 | Frailty |
| ID | Term |
|---|---|
| D010335 | Pathologic Processes |
| D013568 | Pathological Conditions, Signs and Symptoms |
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| ID | Term |
|---|---|
| D008687 | Metformin |
| ID | Term |
|---|---|
| D001645 | Biguanides |
| D006146 | Guanidines |
| D000578 | Amidines |
| D009930 | Organic Chemicals |
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|
| Placebo | 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. |
|
Measurement: handgrip dynamometer (Jamar Hydraulic Hand Dynamometer Model J00105)
| Baseline and at 16 weeks |
| Change from baseline in gait speed at 16 weeks | Measurement: 15-feet walking test | Baseline and at 16 weeks |
| Change from baseline in serum myostatin levels at 16 weeks | Measurement: ELISA test | Baseline and at 16 weeks |