Pre-frail ElderlyPhase 3NCT02325245
Effects of Metformin in Pre-frail Elderly
A Phase 3 study testing Metformin in people with Pre-frail Elderly, run by Universitas Indonesia at 1 site in Indonesia.
Trial 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. Read more about this study
- Who is it for?
- Ages 60 years and older
- Conditions the study is for
- Pre-frail Elderly
- What is being tested?
- Metformin
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 150 participants
- Where
- 1 siteIndonesia
- Study dates
- Mar 2015to Mar 2017
- Phase
- Phase 3
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 60 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Pre-frail elderly;
- Capable to understand and carry-out the instruction.
Who cannot join
- 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);
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- 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.
Trial locations and contacts
1 site in 1 country.
Indonesia1 site, 1 recruiting
- Recruiting
Cipto Mangunkusumo General Hospital
Central Jakarta, Jakarta Special Capital Region, 10430
Purwita Laksmi, MD, +62-21-3918301, pwlaksmi@yahoo.com
About this study
Official title: Randomized-Controlled Trial of Metformin to Prevent Frailty in Pre-frail Elderly
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.
- Conditions
- Pre-frail Elderly
- Being tested
- Metformin, Placebo
- Keywords
- Frailty, Pre-frailty, Metformin, Elderly, Quality of life, Handgrip, Gait speed, Myostatin
- Medical subject headings
- Frailty
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
MetforminDrug
Also called CAS Number: 657-24-9, ATC Code: A10BA02
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.
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.
| Study group | Role | What they receive |
|---|---|---|
| Metformin | Experimental | Metformin tablet 500 mg three times a day for 16 weeks. Receives: Drug: Metformin |
| Placebo | Placebo comparator | Placebo tablet three times a day for 16 weeks. Receives: Drug: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change from baseline in frailty status at 16 weeks
Measurement: Frailty Index 40 items
Measured: Baseline and at 16 weeks
Secondary outcomes (4)
Change from baseline in health-related quality of life (HrQoL) at 16 weeks
Measurement: EQ-5D (with permission)
Measured: Baseline and at 16 weeks
Change from baseline in handgrip strength at 16 weeks
Measurement: handgrip dynamometer (Jamar Hydraulic Hand Dynamometer Model J00105)
Measured: Baseline and at 16 weeks
Change from baseline in gait speed at 16 weeks
Measurement: 15-feet walking test
Measured: Baseline and at 16 weeks
Change from baseline in serum myostatin levels at 16 weeks
Measurement: ELISA test
Measured: Baseline and at 16 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted24 Dec 2014 (estimated)
- Study startMar 2015
- Primary completionDec 2016 (estimated)
- Study completionMar 2017 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for Pre-frail ElderlyStudies of the same condition, open and under way.
- More trials run by Universitas IndonesiaThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 3
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 150 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Universitas Indonesia
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Purwita Wijaya Laksmi, Universitas Indonesia
- Investigators
- Purwita Laksmi, MD,SpPD-KGer, Principal investigator, Division of Geriatrics, Department of Internal Medicine, Universitas Indonesia-Cipto Mangunkusumo General Hospital, Jakarta
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02325245
- Sponsor's protocol ID
- FRAIL-01
- Status last verified
- Sep 2016
- First submitted
- 19 Dec 2014
- Last updated
- 14 Sep 2016
- Results posted
- No
- Data monitoring committee
- Yes
- Individual data sharing
- Yes
Publications
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.
PubMed 25348180Wang 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.
PubMed 25506599
Study at a glance
From the registry record, last updated by the sponsor on 14 Sep 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Randomized-Controlled Trial of Metformin to Prevent Frailty in Pre-frail Elderly
- ClinicalTrials.gov ID
- NCT02325245
- Acronym / sponsor ID
- FRAIL-01
- Conditions
- Pre-frail Elderly
- Keywords
- Frailty, Pre-frailty, Metformin, Elderly, Quality of life, Handgrip, Gait speed, Myostatin
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 150 participants (estimated)
- Lead sponsor
- Universitas IndonesiaUniversity, hospital or other
- Study start
- Mar 2015
- Primary completion
- Dec 2016 (estimated)
- Study completion
- Mar 2017 (estimated)
- First posted
- 24 Dec 2014 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Metformin | Experimental | Drug: MetforminMetformin tablet 500 mg three times a day for 16 weeks. |
| Placebo | Placebo comparator | Drug: PlaceboPlacebo tablet three times a day for 16 weeks. |
Who may qualify
- Ages
- 60 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- Pre-frail elderly;
- Capable to understand and carry-out the instruction.
Key exclusion criteria (11 listed)
- 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;
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| MetforminAlso: CAS Number: 657-24-9, ATC Code: A10BA02Metformin 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. | Drug | Metformin |
| PlaceboPlacebo 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. | Drug | Placebo |
Primary outcome
Change from baseline in frailty status at 16 weeks
Time frame: Baseline and at 16 weeks
Measurement: Frailty Index 40 items
4 secondary outcomes
Change from baseline in health-related quality of life (HrQoL) at 16 weeks
Time frame: Baseline and at 16 weeks
Change from baseline in handgrip strength at 16 weeks
Time frame: Baseline and at 16 weeks
Change from baseline in gait speed at 16 weeks
Time frame: Baseline and at 16 weeks
Change from baseline in serum myostatin levels at 16 weeks
Time frame: Baseline and at 16 weeks
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 14 Sep 2016.
- Background: PubMed 25348180Sumantri 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.
- Background: PubMed 25506599Wang 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.
- Individual participant dataSharing planned: Yes
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Purwita Laksmi, MD,SpPD-KGer principal investigator
Division of Geriatrics, Department of Internal Medicine, Universitas Indonesia-Cipto Mangunkusumo General Hospital, Jakarta
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing Metformin in people with Pre-frail Elderly, run by Universitas Indonesia at 1 site in Indonesia.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 11 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 14 Sep 2016. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Indonesia. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Each site lists its own contact: choose the nearest one under Trial locations. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change from baseline in frailty status at 16 weeks (time frame: Baseline and at 16 weeks). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT02325245, which also lists 2 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 14 Sep 2016.