Impact of Metformin on Immunity

Phase 1

Completed

• Conditions: Aging; Vaccine Response Impaired

• Registration Number: NCT03713801
• Lead Sponsor: The University of Texas Health Science Center at San Antonio

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Start: 2018-10-17
• Last Update Posted: 2 September 2024

Recruitment & Eligibility

• Status: Completed
• Sex: All
• Target Recruitment: Not specified

Inclusion Criteria

Inclusion Criteria:<br><br> 1. Age 63 to 89 years of age<br><br> 2. No history of pneumococcal vaccinations<br><br> 3. Able to take oral medications<br><br> 4. Able to provide informed consent<br><br> 5. Not currently taking metformin<br><br>Exclusion Criteria:<br><br> 1. Previous vaccination with any pneumococcal vaccine<br><br> 2. Metformin within the last 6 months<br><br> 3. Contraindication for PCV13<br><br> 4. History of severe adverse reaction associated with any vaccine component<br><br> 5. Residence in long-term care facility<br><br> 6. Diagnosis of diabetes (diagnosis of pre-diabetes okay)<br><br> 7. Chronic renal disease (or eGFR <50 mL/min) or renal failure (defined as receipt of<br> renal dialysis or transplant) or nephrotic syndrome<br><br> 8. History of adverse reaction or contraindications associated with metformin<br><br> 9. Recent history or plan for radiocontrast<br><br> 10. Self-reported dementia or severe cognitive impairment<br><br> 11. Receipt of blood products within 6 months before enrollment<br><br> 12. History of heart disease (New York Heart Classification greater than class II; more<br> than non-specific ST-T wave changes on the ECG)<br><br> 13. History of chronic obstructive pulmonary disease<br><br> 14. Poorly controlled blood pressure (systolic BP>160, diastolic BP>90 mmHg)<br><br> 15. History of an immunodeficiency<br><br> 16. Use of use of investigational products, antibiotics, probiotics, or systemic<br> immunosuppressive therapy (systemic steroids) within 1 month of study start;<br> patients who are taking these medications chronically, with no expected<br> discontinuation during the study period would not be considered ineligible.<br><br> 17. Treatment with anticoagulants (warfarin)<br><br> 18. Donated blood within the last 2 months<br><br> 19. Subject is considered unsuitable for the study in the opinion of the investigator<br> for any other reason

Exclusion Criteria

Not provided

Study & Design

• Study Type: Interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Change in antibody responses to PCV13

Secondary Outcome Measures

Name	Time	Method
Measure of immunophenotypes