Clinical trial NCT02325245: Effects of Metformin in Pre-frail Elderly
Official title: Randomized-Controlled Trial of Metformin to Prevent Frailty in Pre-frail Elderly
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: PHASE3
Conditions: Pre-frail Elderly
Keywords: Frailty
Pre-frailty
Metformin
Elderly
Quality of life
Handgrip
Gait speed
Myostatin
Lead sponsor: Indonesia University
Sponsor class: OTHER
First posted: 2014-12-24
Enrollment: 150
Sex: ALL
Minimum age (years): 60
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.


Eligibility 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.

Primary outcomes:
measure: Change from baseline in frailty status at 16 weeks
timeFrame: Baseline and at 16 weeks
Secondary outcomes:
measure: Change from baseline in health-related quality of life (HrQoL) at 16 weeks
timeFrame: Baseline and at 16 weeks
measure: Change from baseline in handgrip strength at 16 weeks
timeFrame: Baseline and at 16 weeks
measure: Change from baseline in gait speed at 16 weeks
timeFrame: Baseline and at 16 weeks
measure: Change from baseline in serum myostatin levels at 16 weeks
timeFrame: Baseline and at 16 weeks
Other outcomes:
Locations:
city: Central Jakarta
country: Indonesia
facility: Cipto Mangunkusumo General Hospital
state: Jakarta
Study officials:
affiliation: Division of Geriatrics, Department of Internal Medicine, Universitas Indonesia-Cipto Mangunkusumo General Hospital, Jakarta
name: Purwita Laksmi, MD,SpPD-KGer
role: PRINCIPAL_INVESTIGATOR
References:
citation: 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.
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):1031.