Effects of Metformin in Pre-frail Elderly

Phase 3

• Conditions: Pre-frail Elderly
• Interventions: Drug: Placebo; Drug: Metformin

• Registration Number: NCT02325245
• Lead Sponsor: Indonesia University

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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2014-12-19
• Study First Submitted QC: 2014-12-19
• Study First Posted: 2014-12-24
• Study Start: 2015-03
• Status Verified: 2016-09
• Last Update Submitted: 2016-09-13
• Last Update Posted: 2016-09-14
• Primary Completion: 2016-12
• Study Completion: 2017-03

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 150

Inclusion Criteria

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

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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.

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Placebo	Placebo	Placebo tablet three times a day for 16 weeks.
Metformin	Metformin	Metformin tablet 500 mg three times a day for 16 weeks.

Primary Outcome Measures

Name	Time	Method
Change from baseline in frailty status at 16 weeks	Baseline and at 16 weeks	Measurement: Frailty Index 40 items

Secondary Outcome Measures

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

Trial Locations

Locations (1)

Cipto Mangunkusumo General Hospital; 🇮🇩 Central Jakarta, Jakarta, Indonesia