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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

Tracking Information
First Submitted Date  ICMJE December 19, 2014
First Posted Date  ICMJE December 24, 2014
Last Update Posted Date September 14, 2016
Study Start Date  ICMJE March 2015
Estimated Primary Completion Date December 2016   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: December 19, 2014)
Change from baseline in frailty status at 16 weeks [ Time Frame: Baseline and at 16 weeks ]
Measurement: Frailty Index 40 items
Original Primary Outcome Measures  ICMJE Same as current
Change History
Current Secondary Outcome Measures  ICMJE
 (submitted: December 19, 2014)
  • 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
Original Secondary Outcome Measures  ICMJE Same as current
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Effects of Metformin in Pre-frail Elderly
Official Title  ICMJE Randomized-Controlled Trial of Metformin to Prevent Frailty in Pre-frail Elderly
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.

Detailed Description Not Provided
Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 3
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Condition  ICMJE Pre-frail Elderly
Intervention  ICMJE
  • 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
  • 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.
Study Arms  ICMJE
  • Experimental: Metformin
    Metformin tablet 500 mg three times a day for 16 weeks.
    Intervention: Drug: Metformin
  • Placebo Comparator: Placebo
    Placebo tablet three times a day for 16 weeks.
    Intervention: Drug: Placebo
Publications *

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Unknown status
Estimated Enrollment  ICMJE
 (submitted: December 19, 2014)
150
Original Estimated Enrollment  ICMJE Same as current
Estimated Study Completion Date  ICMJE March 2017
Estimated Primary Completion Date December 2016   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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.
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 60 Years and older   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE Indonesia
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT02325245
Other Study ID Numbers  ICMJE FRAIL-01
Has Data Monitoring Committee Yes
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE
Plan to Share IPD: Yes
Responsible Party Purwita Wijaya Laksmi, Indonesia University
Study Sponsor  ICMJE Indonesia University
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Principal Investigator: Purwita Laksmi, MD,SpPD-KGer Division of Geriatrics, Department of Internal Medicine, Universitas Indonesia-Cipto Mangunkusumo General Hospital, Jakarta
PRS Account Indonesia University
Verification Date September 2016

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP