CompletedPhase 1

Impact of Metformin on Immunity

United States18 participantsStarted 2019-01-14

Plain-language summary

To determine whether metformin (MET) can improve the immune response to the pneumococcal conjugate vaccine (PCV-13) in older adults.

Who can participate

Age range

63 Years – 90 Years

Sex

ALL

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

Inclusion criteria

. Age 63 to 89 years of age
. No history of pneumococcal vaccinations
. Able to take oral medications
. Able to provide informed consent
. Not currently taking metformin

Exclusion criteria

. Previous vaccination with any pneumococcal vaccine
. Metformin within the last 6 months
. Contraindication for PCV13
. History of severe adverse reaction associated with any vaccine component
. Residence in long-term care facility
. Diagnosis of diabetes (diagnosis of pre-diabetes okay)
. Chronic renal disease (or eGFR \<50 mL/min) or renal failure (defined as receipt of renal dialysis or transplant) or nephrotic syndrome

Questions worth asking your doctor

Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.

1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?

Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.

Questions for the trial coordinator

The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.

1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?

A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.

What they're measuring

Change in antibody responses to PCV13

Timeframe: Change from 4 weeks to 8 weeks

Trial details

NCT IDNCT03713801

SponsorThe University of Texas Health Science Center at San Antonio

Sponsor typeOTHER

Study typeINTERVENTIONAL

Primary completion2024-07-16

View on ClinicalTrials.gov More Aging trials