Effects of Metformin in Pre-frail Elderly

• Register: ClinicalTrials.gov
• Last refreshed on: 26 September 2016
• Main ID: NCT02325245
• Date of registration: 19/12/2014
• Prospective Registration: Yes
• Primary sponsor: Indonesia University
• Public title: Effects of Metformin in Pre-frail Elderly
• Scientific title: Randomized-Controlled Trial of Metformin to Prevent Frailty in Pre-frail Elderly
• Date of first enrolment: March 2015
• Target sample size: 150
• Recruitment status: Recruiting
• URL: https://clinicaltrials.gov/show/NCT02325245
• Study type: Interventional
• Study design: Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Primary Purpose: Treatment
• Phase: Phase 3

Countries of recruitment

Indonesia

Contacts

• Name: Purwita Laksmi, MD

• Name: Purwita Laksmi, MD,SpPD-KGer
• Affiliation: Division of Geriatrics, Department of Internal Medicine, Universitas Indonesia-Cipto Mangunkusumo General Hospital, Jakarta

Key inclusion & exclusion criteria

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.



Age minimum: 60 Years
Age maximum: N/A
Gender: Both

Health Condition(s) or Problem(s) studied

Pre-frail Elderly

Intervention(s)

Drug: Metformin

Drug: Placebo

Primary Outcome(s)

Change from baseline in frailty status at 16 weeks [Time Frame: Baseline and at 16 weeks]

Secondary Outcome(s)

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]

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]

Secondary ID(s)

FRAIL-01

Source(s) of Monetary Support

Please refer to primary and secondary sponsors