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Effects of Metformin in Pre-frail Elderly

U

University of Indonesia (UI)

Status and phase

Unknown
Phase 3

Conditions

Pre-frail Elderly

Treatments

Drug: Metformin
Drug: Placebo

Study type

Interventional

Funder types

Other

Identifiers

NCT02325245
FRAIL-01

Details and patient eligibility

About

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.

Enrollment

150 estimated patients

Sex

All

Ages

60+ years old

Volunteers

No Healthy Volunteers

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.

Trial design

Primary purpose

Treatment

Allocation

Randomized

Interventional model

Parallel Assignment

Masking

Quadruple Blind

150 participants in 2 patient groups, including a placebo group

Metformin
Experimental group
Description:
Metformin tablet 500 mg three times a day for 16 weeks.
Treatment:
Drug: Metformin
Placebo
Placebo Comparator group
Description:
Placebo tablet three times a day for 16 weeks.
Treatment:
Drug: Placebo

Trial contacts and locations

1

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Data sourced from clinicaltrials.gov

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