Effects of Metformin in Pre-frail Elderly

Pre-frail Elderly Clinical Trial

Official title:

Randomized-Controlled Trial of Metformin to Prevent Frailty in Pre-frail Elderly

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT02325245
• Other study ID #: FRAIL-01
• Status: Recruiting
• Phase: Phase 3
• First received: December 19, 2014
• Last updated: September 13, 2016
• Start date: March 2015
• Est. completion date: March 2017

Study information

• Verified date: September 2016
• Source: Indonesia University
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical 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.

We hypothesize that metformin for 16 weeks could prevent frailty in pre-frail elderly.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 150
• Est. completion date: March 2017
• Est. primary completion date: December 2016
• Accepts healthy volunteers: No
• Gender: All
• Age group: 60 Years and older

Eligibility

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.

Related Conditions & MeSH terms

• Pre-frail Elderly

Intervention

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.
• 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.

Locations

Country	Name	City	State
Indonesia	Cipto Mangunkusumo General Hospital	Central Jakarta	Jakarta

Sponsors (1)

Lead Sponsor	Collaborator
Indonesia University

Country where clinical trial is conducted

Indonesia, 

References & 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. — View 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). pii: 1031. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Change from baseline in frailty status at 16 weeks	Measurement: Frailty Index 40 items	Baseline and at 16 weeks
Secondary	Change from baseline in health-related quality of life (HrQoL) at 16 weeks	Measurement: EQ-5D (with permission)	Baseline and at 16 weeks
Secondary	Change from baseline in handgrip strength at 16 weeks	Measurement: handgrip dynamometer (Jamar Hydraulic Hand Dynamometer Model J00105)	Baseline and at 16 weeks
Secondary	Change from baseline in gait speed at 16 weeks	Measurement: 15-feet walking test	Baseline and at 16 weeks
Secondary	Change from baseline in serum myostatin levels at 16 weeks	Measurement: ELISA test	Baseline and at 16 weeks