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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
Sponsor:
Information provided by (Responsible Party):
Purwita Wijaya Laksmi, Indonesia University

Study Description
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Brief Summary:

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 Design
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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

Resource links provided by the National Library of Medicine


Arms and Interventions
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Arm Intervention/treatment
Experimental: Metformin
Metformin tablet 500 mg three times a day for 16 weeks.
 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:
  • CAS Number: 657-24-9
  • ATC Code: A10BA02
Placebo Comparator: Placebo
Placebo tablet three times a day for 16 weeks.
 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.


Outcome Measures
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Primary Outcome Measures :
  1. Change from baseline in frailty status at 16 weeks [ Time Frame: Baseline and at 16 weeks ]
    Measurement: Frailty Index 40 items


Secondary Outcome Measures :
  1. 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)

  2. 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)

  3. Change from baseline in gait speed at 16 weeks [ Time Frame: Baseline and at 16 weeks ]
    Measurement: 15-feet walking test

  4. Change from baseline in serum myostatin levels at 16 weeks [ Time Frame: Baseline and at 16 weeks ]
    Measurement: ELISA test


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

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.
Contacts and Locations
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Information from the National Library of Medicine

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


Locations
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Indonesia
Cipto Mangunkusumo General Hospital Recruiting
Central Jakarta, Jakarta, Indonesia, 10430
Contact: Purwita Laksmi, MD    +62-21-3918301    pwlaksmi@yahoo.com   
Sponsors and Collaborators
Indonesia University
Investigators
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Principal Investigator: Purwita Laksmi, MD,SpPD-KGer Division of Geriatrics, Department of Internal Medicine, Universitas Indonesia-Cipto Mangunkusumo General Hospital, Jakarta
More Information
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Publications:

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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
Keywords provided by Purwita Wijaya Laksmi, Indonesia University:
Frailty
Pre-frailty
Metformin
Elderly
 Quality of life
Handgrip
Gait speed
Myostatin
Additional relevant MeSH terms:
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Frailty
Pathologic Processes
Metformin
Hypoglycemic Agents
Physiological Effects of Drugs