NCT02325245

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.

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
150

participants targeted

Target at P25-P50 for phase_3

Timeline
Completed

Started Mar 2015

Geographic Reach
1 country

1 active site

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

December 19, 2014

Completed
5 days until next milestone

First Posted

Study publicly available on registry

December 24, 2014

Completed
2 months until next milestone

Study Start

First participant enrolled

March 1, 2015

Completed
1.8 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 1, 2016

Completed
3 months until next milestone

Study Completion

Last participant's last visit for all outcomes

March 1, 2017

Completed
Last Updated

September 14, 2016

Status Verified

September 1, 2016

Enrollment Period

1.8 years

First QC Date

December 19, 2014

Last Update Submit

September 13, 2016

Conditions

Pre-frail Elderly

Keywords

FrailtyPre-frailtyMetforminElderlyQuality of lifeHandgripGait speedMyostatin

Outcome Measures

Primary Outcomes (1)

  • Change from baseline in frailty status at 16 weeks

    Measurement: Frailty Index 40 items

    Baseline and at 16 weeks

Secondary Outcomes (4)

  • Change from baseline in health-related quality of life (HrQoL) at 16 weeks

    Baseline and at 16 weeks

  • Change from baseline in handgrip strength at 16 weeks

    Baseline and at 16 weeks

  • Change from baseline in gait speed at 16 weeks

    Baseline and at 16 weeks

  • Change from baseline in serum myostatin levels at 16 weeks

    Baseline and at 16 weeks

Study Arms (2)

Metformin

EXPERIMENTAL

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

Drug: Metformin

Placebo

PLACEBO COMPARATOR

Placebo tablet three times a day for 16 weeks.

Drug: Placebo

Interventions

MetforminDRUG

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.

Also known as: CAS Number: 657-24-9, ATC Code: A10BA02
Metformin
PlaceboDRUG

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.

Placebo

Eligibility Criteria

Age60 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Pre-frail elderly;
  • Capable to understand and carry-out the instruction.

You may not qualify if:

  • 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;
  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Cipto Mangunkusumo General Hospital

Central Jakarta, Jakarta Special Capital Region, 10430, Indonesia

RECRUITING

Related Publications (2)

  • 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.

    PMID: 25348180BACKGROUND

  • 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.

    PMID: 25506599BACKGROUND

MeSH Terms

Conditions

Frailty

Interventions

Metformin

Condition Hierarchy (Ancestors)

Pathologic ProcessesPathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

BiguanidesGuanidinesAmidinesOrganic Chemicals

Study Officials

  • Purwita Laksmi, MD,SpPD-KGer

    Division of Geriatrics, Department of Internal Medicine, Universitas Indonesia-Cipto Mangunkusumo General Hospital, Jakarta

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
phase 3
Allocation
RANDOMIZED
Masking
QUADRUPLE
Who Masked
PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Purwita Wijaya Laksmi, MD, SpPD-KGer

Study Record Dates

First Submitted

December 19, 2014

First Posted

December 24, 2014

Study Start

March 1, 2015

Primary Completion

December 1, 2016

Study Completion

March 1, 2017

Last Updated

September 14, 2016

Record last verified: 2016-09

Data Sharing

IPD Sharing
Will share

Locations

ID(1)