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Biguanide

Metformin for Preventing Frailty in Older Adults

Phase 2
Waitlist Available
Led By Sara E Espinoza, M.D.
Research Sponsored by The University of Texas Health Science Center at San Antonio
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Age 65 and older
Be older than 65 years old
Timeline
Screening 3 weeks
Treatment Varies
Follow Up 2 years
Awards & highlights

Study Summary

This trial will test whether metformin can prevent frailty in older adults.

Who is the study for?
This trial is for men and women aged 65 or older who are at risk of becoming frail. They must be pre-diabetic but not diagnosed with diabetes in the past year, live in their own home (not a care facility), and have certain normal lab values indicating good organ function. People already considered frail, with chronic diseases like heart disease or autoimmune conditions, on certain medications affecting glucose levels, or with cognitive impairments cannot join.Check my eligibility
What is being tested?
The study is testing whether metformin can prevent or slow down frailty compared to a placebo (a pill without any medicine). Frailty leads to health issues like falls and hospitalization. Metformin could help by managing blood sugar levels and inflammation which are thought to contribute to frailty.See study design
What are the potential side effects?
Metformin may cause side effects such as digestive upset (like diarrhea or stomach pain), weakness, low blood sugar levels especially if meals are skipped, and possibly vitamin B12 deficiency over long-term use.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below
Select...
I am 65 years old or older.

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~2 years
This trial's timeline: 3 weeks for screening, Varies for treatment, and 2 years for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.
Primary outcome measures
Frailty composite measure

Side effects data

From 2015 Phase 4 trial • 156 Patients • NCT02002221
13%
Nasopharyngitis
10%
Hyperhidrosis
9%
Hunger
9%
Tremor
8%
Asthenia
6%
Hypoglycaemia
1%
Squamous cell carcinoma of the tongue
1%
Femoral neck fracture
100%
80%
60%
40%
20%
0%
Study treatment Arm
Vildagliptin (LAF237)
Placebo

Trial Design

2Treatment groups
Experimental Treatment
Placebo Group
Group I: MetforminExperimental Treatment1 Intervention
Subjects will be randomized to metformin (titrated up to 1000 mg twice daily, as tolerated)
Group II: PlaceboPlacebo Group1 Intervention
Subjects will be randomized to metformin (titrated up to 1000 mg twice daily, as tolerated) vs. placebo.
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Metformin
2006
Completed Phase 4
~2430

Find a Location

Who is running the clinical trial?

The University of Texas Health Science Center at San AntonioLead Sponsor
450 Previous Clinical Trials
87,116 Total Patients Enrolled
2 Trials studying Frailty
24 Patients Enrolled for Frailty
National Institute on Aging (NIA)NIH
1,655 Previous Clinical Trials
28,004,689 Total Patients Enrolled
21 Trials studying Frailty
11,208 Patients Enrolled for Frailty
Sara E Espinoza, M.D.Principal InvestigatorAssociate Professor

Media Library

Metformin (Biguanide) Clinical Trial Eligibility Overview. Trial Name: NCT02570672 — Phase 2
Frailty Research Study Groups: Placebo, Metformin
Frailty Clinical Trial 2023: Metformin Highlights & Side Effects. Trial Name: NCT02570672 — Phase 2
Metformin (Biguanide) 2023 Treatment Timeline for Medical Study. Trial Name: NCT02570672 — Phase 2

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

Are there vacancies currently available for prospective participants in this trial?

"Affirmative, the information on clinicaltrials.gov affirms that this trial is actively searching for participants. Initially posted in April 2016 and last amended in November 2021, 120 patients are sought to join at a single research site."

Answered by AI

What has the research revealed about Metformin's efficacy in prior investigations?

"Currently, 170 studies are being conducted on Metformin. Of these active trials, 43 have reached Phase 3 of the clinical trial process. While Pittsburgh is home to the bulk of experiments involving this drug, 1902 different sites across the world are running research into its efficacy."

Answered by AI

Who qualifies for enrollment in this clinical trial?

"This trial is searching for 120 elderly individuals with pre-diabetic symptoms. The necessary qualifications must be met, namely: Pre-diabetes based on an oral glucose tolerance test where 2 hours values are between 140 - 199 mg/dL following consumption of a sugar load; no diabetes diagnosis within the last year, Men and women from all ethnicities aged 65 or older who live in a community setting, Hematocrit ≥ 33%, aspartate aminotransferase < 2 X upper limit of normal, alanine aminotransferase < 2 X upper limit of normal, alkaline phosphatase < 2"

Answered by AI

What degree of safety has been established for Metformin use?

"Metformin's safety has been partially established through Phase 2 trials and thusly, Power rated it a two out of three on the spectrum of risk."

Answered by AI

How many volunteers have enrolled in the experiment thus far?

"Affirmative. Clinicaltrials.gov displays that this experiment is actively seeking individuals, with the original posting occurring on April 1st 2016 and an update to the trial taking place November 3rd 2021. The study requires a total of 120 participants from one medical site."

Answered by AI

Is the eligibility criterion for this research study restricted to individuals aged 18 and over?

"This clinical trial has an age range of 65 to 90 years old, which must be met by participants for their inclusion in the study."

Answered by AI

For what kind of medical issues is Metformin commonly prescribed?

"Metformin is an efficacious intervention for managing type 1 diabetes mellitus, exercise-induced fatigue and diabetic ketoacidosis."

Answered by AI
~16 spots leftby Mar 2025