NCT03713801

Impact of Metformin on Immunity

Completed Phase 1 Last updated 20 August 2024

What this trial tests

Phase 1 trial testing Metformin in Aging in 18 participants. Completed in 16 July 2024.

Timeline

14 January 2019

Primary endpoint
16 July 2024

16 July 2024

Quick facts

Lead sponsor	The University of Texas Health Science Center at San Antonio
Phase	Phase 1
Status	Completed
Study type	INTERVENTIONAL
Allocation	randomized
Design	parallel
Masking	triple
Primary purpose	basic science
Enrollment	18
Start date	14 January 2019
Primary completion	16 July 2024
Estimated completion	16 July 2024
Sites	1 location across United States

Drugs / interventions tested

• Metformin (metformin) — full drug profile →
• Placebo

Conditions studied

• Aging — all drugs for Aging →
• Vaccine Response Impaired — all drugs for Vaccine Response Impaired →

Sponsor

The University of Texas Health Science Center at San Antonio

Who can join

Adults 63 to 90, any sex, with Aging or Vaccine Response Impaired. Patients with the condition only — healthy volunteers not accepted.

Sponsor's own description

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

Publications & conference data

7 peer-reviewed publications reference this trial (live from Europe PMC):

1. Benefits of Metformin in Attenuating the Hallmarks of Aging.
   Kulkarni AS, Gubbi S, Barzilai N. · · 2020 · cited 555× · PMID 32333835 · DOI 10.1016/j.cmet.2020.04.001
2. Metformin in aging and aging-related diseases: clinical applications and relevant mechanisms.
   Chen S, Gan D, Lin S, Zhong Y, et al · · 2022 · cited 110× · PMID 35401820 · DOI 10.7150/thno.71360
3. Insights into vaccines for elderly individuals: from the impacts of immunosenescence to delivery strategies.
   Hou Y, Chen M, Bian Y, Hu Y, et al · · 2024 · cited 62× · PMID 38600250 · DOI 10.1038/s41541-024-00874-4
4. A geroscience perspective on immune resilience and infectious diseases: a potential case for metformin.
   Justice JN, Gubbi S, Kulkarni AS, Bartley JM, et al · · 2021 · cited 37× · PMID 32902818 · DOI 10.1007/s11357-020-00261-6
5. Chronic HIV Infection and Aging: Application of a Geroscience-Guided Approach.
   Masters MC, Landay AL, Robbins PD, Tchkonia T, et al · · 2022 · cited 21× · PMID 35015744 · DOI 10.1097/qai.0000000000002858
6. Drugs Targeting Mechanisms of Aging to Delay Age-Related Disease and Promote Healthspan: Proceedings of a National Institute on Aging Workshop.
   Espinoza SE, Khosla S, Baur JA, de Cabo R, et al · · 2023 · cited 19× · PMID 37325957 · DOI 10.1093/gerona/glad034
7. Effect of Cellular Senescence in Disease Progression and Transplantation: Immune Cells and Solid Organs.
   Kirchner VA, Badshah JS, Hong SK, Martinez O, et al · · 2024 · cited 8× · PMID 37953486 · DOI 10.1097/tp.0000000000004838