Impact of Metformin on Immunity
Lay Description
To determine whether metformin (MET) can improve the immune response to the pneumococcal conjugate vaccine (PCV-13) in older adults.
Category
- IRB Number
- 20180171HU
- NCT Number
- NCT03713801
- Open to Enrollment
- Yes
Eligibility
- Eligible Ages
- Between 63 Years and 90 Years
- Eligible Genders
- All
- Accepts Healthy Volunteers
- Yes
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
- History of adverse reaction or contraindications associated with metformin
- Recent history or plan for radiocontrast
- Self-reported dementia or severe cognitive impairment
- Receipt of blood products within 6 months before enrollment
- History of heart disease (New York Heart Classification greater than class II; more than non-specific ST-T wave changes on the ECG)
- History of chronic obstructive pulmonary disease
- Poorly controlled blood pressure (systolic BP>160, diastolic BP>90 mmHg)
- History of an immunodeficiency
- Use of use of investigational products, antibiotics, probiotics, or systemic immunosuppressive therapy (systemic steroids) within 1 month of study start; patients who are taking these medications chronically, with no expected discontinuation during the study period would not be considered ineligible.
- Treatment with anticoagulants (warfarin)
- Donated blood within the last 2 months
- Subject is considered unsuitable for the study in the opinion of the investigator for any other reason
Study Design
Arm Groups
Study Contact
Grace Lee
(210) 567-8355
leeg3@uthscsa.edu
Grace Lee
(210) 567-8355
leeg3@uthscsa.edu
Principal Investigator
Grace Lee