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
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|
|Pre-frail Elderly||Drug: Metformin Drug: Placebo||Phase 3|
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||150 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)|
|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|
Metformin tablet 500 mg three times a day for 16 weeks.
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 Comparator: Placebo
Placebo tablet three times a day for 16 weeks.
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
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
|Cipto Mangunkusumo General Hospital||Recruiting|
|Central Jakarta, Jakarta, Indonesia, 10430|
|Contact: Purwita Laksmi, MD +62-21-3918301 firstname.lastname@example.org|
|Principal Investigator:||Purwita Laksmi, MD,SpPD-KGer||Division of Geriatrics, Department of Internal Medicine, Universitas Indonesia-Cipto Mangunkusumo General Hospital, Jakarta|