search
Back to results

Effects of Metformin in Pre-frail Elderly

Primary Purpose

Pre-frail Elderly

Status
Unknown status
Phase
Phase 3
Locations
Indonesia
Study Type
Interventional
Intervention
Metformin
Placebo
Sponsored by
Indonesia University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Pre-frail Elderly focused on measuring Frailty, Pre-frailty, Metformin, Elderly, Quality of life, Handgrip, Gait speed, Myostatin

Eligibility Criteria

60 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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.

Sites / Locations

  • Cipto Mangunkusumo General HospitalRecruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Placebo Comparator

Arm Label

Metformin

Placebo

Arm Description

Metformin tablet 500 mg three times a day for 16 weeks.

Placebo tablet three times a day for 16 weeks.

Outcomes

Primary Outcome Measures

Change from baseline in frailty status at 16 weeks
Measurement: Frailty Index 40 items

Secondary Outcome Measures

Change from baseline in health-related quality of life (HrQoL) at 16 weeks
Measurement: EQ-5D (with permission)
Change from baseline in handgrip strength at 16 weeks
Measurement: handgrip dynamometer (Jamar Hydraulic Hand Dynamometer Model J00105)
Change from baseline in gait speed at 16 weeks
Measurement: 15-feet walking test
Change from baseline in serum myostatin levels at 16 weeks
Measurement: ELISA test

Full Information

First Posted
December 19, 2014
Last Updated
September 13, 2016
Sponsor
Indonesia University
search

1. Study Identification

Unique Protocol Identification Number
NCT02325245
Brief Title
Effects of Metformin in Pre-frail Elderly
Official Title
Randomized-Controlled Trial of Metformin to Prevent Frailty in Pre-frail Elderly
Study Type
Interventional

2. Study Status

Record Verification Date
September 2016
Overall Recruitment Status
Unknown status
Study Start Date
March 2015 (undefined)
Primary Completion Date
December 2016 (Anticipated)
Study Completion Date
March 2017 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Indonesia University

4. Oversight

Data Monitoring Committee
Yes

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Pre-frail Elderly
Keywords
Frailty, Pre-frailty, Metformin, Elderly, Quality of life, Handgrip, Gait speed, Myostatin

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 3
Interventional Study Model
Parallel Assignment
Masking
ParticipantCare ProviderInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
150 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Metformin
Arm Type
Experimental
Arm Description
Metformin tablet 500 mg three times a day for 16 weeks.
Arm Title
Placebo
Arm Type
Placebo Comparator
Arm Description
Placebo tablet three times a day for 16 weeks.
Intervention Type
Drug
Intervention Name(s)
Metformin
Other Intervention Name(s)
CAS Number: 657-24-9, ATC Code: A10BA02
Intervention Description
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.
Intervention Type
Drug
Intervention Name(s)
Placebo
Intervention Description
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.
Primary Outcome Measure Information:
Title
Change from baseline in frailty status at 16 weeks
Description
Measurement: Frailty Index 40 items
Time Frame
Baseline and at 16 weeks
Secondary Outcome Measure Information:
Title
Change from baseline in health-related quality of life (HrQoL) at 16 weeks
Description
Measurement: EQ-5D (with permission)
Time Frame
Baseline and at 16 weeks
Title
Change from baseline in handgrip strength at 16 weeks
Description
Measurement: handgrip dynamometer (Jamar Hydraulic Hand Dynamometer Model J00105)
Time Frame
Baseline and at 16 weeks
Title
Change from baseline in gait speed at 16 weeks
Description
Measurement: 15-feet walking test
Time Frame
Baseline and at 16 weeks
Title
Change from baseline in serum myostatin levels at 16 weeks
Description
Measurement: ELISA test
Time Frame
Baseline and at 16 weeks

10. Eligibility

Sex
All
Minimum Age & Unit of Time
60 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Purwita Laksmi, MD,SpPD-KGer
Organizational Affiliation
Division of Geriatrics, Department of Internal Medicine, Universitas Indonesia-Cipto Mangunkusumo General Hospital, Jakarta
Official's Role
Principal Investigator
Facility Information:
Facility Name
Cipto Mangunkusumo General Hospital
City
Central Jakarta
State/Province
Jakarta
ZIP/Postal Code
10430
Country
Indonesia
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Purwita Laksmi, MD
Phone
+62-21-3918301
Email
pwlaksmi@yahoo.com

12. IPD Sharing Statement

Plan to Share IPD
Yes
Citations:
PubMed Identifier
25348180
Citation
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.
Results Reference
background
PubMed Identifier
25506599
Citation
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.
Results Reference
background

Learn more about this trial

Effects of Metformin in Pre-frail Elderly

We'll reach out to this number within 24 hrs