Summary of Study ST002432

This data is available at the NIH Common Fund's National Metabolomics Data Repository (NMDR) website, the Metabolomics Workbench, https://www.metabolomicsworkbench.org, where it has been assigned Project ID PR001565. The data can be accessed directly via it's Project DOI: 10.21228/M8DD8S This work is supported by NIH grant, U2C- DK119886.

See: https://www.metabolomicsworkbench.org/about/howtocite.php

This study contains a large results data set and is not available in the mwTab file. It is only available for download via FTP as data file(s) here.

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Study ID	ST002432
Study Title	Metabolic impacts of metformin to seasonal influenza vaccination: a pilot study of drug interaction with the immune response
Study Summary	We report here a double-blinded pilot study of seasonal influenza vaccination, where half of the participants received daily metformin administration. Global metabolomics was measured in the plasma samples at six timepoints. Metformin signatures were successfully identified in the metabolomics data. Statistically significant metabolite features were found both for the vaccination effect and for the drug-vaccine interactions.
Institute	The Jackson Laboratory for Genomic Medicine
Laboratory	Shuzhao Li Lab
Last Name	Siddiqa
First Name	Amnah
Address	10 Discovery dr, Farmington, CT 06032
Email	amnah.siddiqa@jax.org
Phone	4049187223
Submit Date	2023-01-04
Raw Data Available	Yes
Raw Data File Type(s)	mzML
Analysis Type Detail	LC-MS
Release Date	2023-01-20
Release Version	1

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Treatment:

Treatment ID:	TR002533
Treatment Summary:	This pilot study is a double-blinded placebo-controlled trial in men and women over the age of 65 years. Subjects were screened rigorously for eligibility. Study exclusion criteria included the following: any unstable medical conditions or severe co-morbidities (severe COPD, severe congestive heart failure, advanced neurological disorders, etc), contraindications for metformin (severe renal or liver impairment), contraindication for flu vaccine (history of Guillain-Barre syndrome post vaccination or allergic to component of vaccine), immunosuppressive disorders, immunosuppressive medications, and active cancer. Importantly, participants were excluded if they were prediabetic or diabetic (HbA1c ≥ 5.7%) to avoid any confounding impact of metformin on diabetes status. Eligible participants were randomized to metformin (final dose 1500mg extended release (ER)/day) or placebo treatment. To limit gastrointestinal issues per current metformin label recommendations, participants started with 1 tablet a day for week 1 (500mg metformin ER/day or placebo), then 2 tablets a day for week 2 (1000mg metformin ER or placebo), and finally 3 tablets a day for week 3 until the completion of the study (1500mg metformin ER or placebo). Fifteen subjects (n=8 metformin, n=7 placebo) were randomized and completed the study on treatment with no differences in basic characteristics at baseline (placebo: 74.71±2.45 years old, 3 males, BMI: 27.31±1.68; metformin: 74.13±2.42 years old, 5 males, BMI: 26.43±1.47). All participants were vaccinated with Fluzone high-dose trivalent flu vaccine (Sanofi Pasteur Inc., Swiftwater, PA) after ~70 days of treatment. Blood was drawn via standard venipuncture into EDTA-treated vacutainers prior to treatment (Day 0), prior to vaccination (~day 35 and ~day 70), and 7, ~35, and ~70 days post vaccination. The study protocol was approved by the Institutional Review Board at the University of Connecticut Health Center (UCHC) and registered at ClinicalTrials.gov (NCT03996538). All study participants provided written informed consent to participate in the study.

Treatment ID:

TR002533

Treatment Summary:

This pilot study is a double-blinded placebo-controlled trial in men and women over the age of 65 years. Subjects were screened rigorously for eligibility. Study exclusion criteria included the following: any unstable medical conditions or severe co-morbidities (severe COPD, severe congestive heart failure, advanced neurological disorders, etc), contraindications for metformin (severe renal or liver impairment), contraindication for flu vaccine (history of Guillain-Barre syndrome post vaccination or allergic to component of vaccine), immunosuppressive disorders, immunosuppressive medications, and active cancer. Importantly, participants were excluded if they were prediabetic or diabetic (HbA1c ≥ 5.7%) to avoid any confounding impact of metformin on diabetes status. Eligible participants were randomized to metformin (final dose 1500mg extended release (ER)/day) or placebo treatment. To limit gastrointestinal issues per current metformin label recommendations, participants started with 1 tablet a day for week 1 (500mg metformin ER/day or placebo), then 2 tablets a day for week 2 (1000mg metformin ER or placebo), and finally 3 tablets a day for week 3 until the completion of the study (1500mg metformin ER or placebo). Fifteen subjects (n=8 metformin, n=7 placebo) were randomized and completed the study on treatment with no differences in basic characteristics at baseline (placebo: 74.71±2.45 years old, 3 males, BMI: 27.31±1.68; metformin: 74.13±2.42 years old, 5 males, BMI: 26.43±1.47). All participants were vaccinated with Fluzone high-dose trivalent flu vaccine (Sanofi Pasteur Inc., Swiftwater, PA) after ~70 days of treatment. Blood was drawn via standard venipuncture into EDTA-treated vacutainers prior to treatment (Day 0), prior to vaccination (~day 35 and ~day 70), and 7, ~35, and ~70 days post vaccination. The study protocol was approved by the Institutional Review Board at the University of Connecticut Health Center (UCHC) and registered at ClinicalTrials.gov (NCT03996538). All study participants provided written informed consent to participate in the study.