Effects of Metformin in Pre-frail Elderly

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.

Study Overview

• Status: Unknown
• Conditions: Pre-frail Elderly
• Intervention / Treatment: Drug: Metformin; Drug: Placebo

• Study Type: Interventional
• Enrollment (Anticipated): 150
• Phase: Phase 3

Contacts and Locations

Study Locations

• Indonesia
  • Jakarta
    • Central Jakarta, Jakarta, Indonesia, 10430
      • Recruiting
      • Cipto mangunkusumo general hospital
      • Contact: Purwita Laksmi, MD; Phone Number: +62-21-3918301; Email: pwlaksmi@yahoo.com

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 60 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Quadruple

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Metformin; Metformin tablet 500 mg three times a day for 16 weeks.	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.; Other Names: CAS Number: 657-24-9; ATC Code: A10BA02
Placebo Comparator: Placebo; Placebo tablet three times a day for 16 weeks.	Drug: 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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Change from baseline in frailty status at 16 weeks	Measurement: Frailty Index 40 items	Baseline and at 16 weeks

Secondary Outcome Measures

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

Collaborators and Investigators

• Sponsor: Indonesia University
• Investigators: Principal Investigator: Purwita Laksmi, MD,SpPD-KGer, Division of Geriatrics, Department of Internal Medicine, Universitas Indonesia-Cipto Mangunkusumo General Hospital, Jakarta

Publications and helpful links

General 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.
• 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.

Study record dates

Study Major Dates

• Study Start: March 1, 2015
• Primary Completion (Anticipated): December 1, 2016
• Study Completion (Anticipated): March 1, 2017

Study Registration Dates

• First Submitted: December 19, 2014
• First Submitted That Met QC Criteria: December 19, 2014
• First Posted (Estimate): December 24, 2014

Study Record Updates

• Last Update Posted (Estimate): September 14, 2016
• Last Update Submitted That Met QC Criteria: September 13, 2016
• Last Verified: September 1, 2016

More Information

Terms related to this study

• Keywords: Elderly; Quality of life; Metformin; Pre-frailty; Frailty; Handgrip; Gait speed; Myostatin
• Additional Relevant MeSH Terms: Pathologic Processes; Frailty; Hypoglycemic Agents; Physiological Effects of Drugs; Metformin
• Other Study ID Numbers: FRAIL-01

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: Yes