CI

At a glance

ClinicalIndex Comparison Record
Phase 2Completed· 32 enrolled
Drug / intervention
MetFORMIN Hydrochloride ER +1 moredrug
Likely dose
MetFORMIN Hydrochloride ER 500mgfrom record
Structured eligibility isn't available for this trial yet — see the full criteria in the Eligibility tab below.

Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.

Search/NCT03772964
NCT03772964Phase 2Completed

A Pilot Study: Metformin as an Inflammatory Modulating Therapy in Older Adults Without Diabetes

Brian Zuckerbraun·interventional·Posted Dec 12, 2018·Updated Jan 11, 2023

In Brief

A Phase 2 clinical trial evaluating MetFORMIN Hydrochloride ER and Placebo for Inflammatory Response. Completed, enrolled 32 participants across 1 site.

Detailed Summary

Metformin has a well-established safety profile and it has become clear that metformin has additional salutary effects, including anti-inflammatory, anti-aging, and anti-thrombotic properties. In this study, subjects will provide both venous blood samples and stool samples in addition to completing cognitive and physiologic testing at baseline, throughout a 90 day exposure to metformin, and 30 days following exposure to metformin in order to evaluate their immune, microbiome, cellular respiration, thrombotic, and inflammatory responses.

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
CountriesUnited States
Collaborators--

Timeline

Phase 2CompletedFinished
20192020202120222023202420252026
First PostedDec 12, 2018
Enrollment StartJan 22, 2019
Primary CompletionMar 31, 2020
TodayJul 2, 2026
Enrollment to primary: 1.2 yearsPosted 7.6 years ago

Interventions

MetFORMIN Hydrochloride ERdrug

Subjects will be exposed to 500mg, 1000mg, or 1500mg of daily ER Metformin, by mouth, for up to 90 days. Subjects will have their venous blood sampled and baseline, throughout the trial, and following completion of their metformin exposure.

Placebodrug

Subjects will be exposed to placebo, by mouth, for up to 90 days. Subjects will have their venous blood sampled and baseline, throughout the trial, and following completion of their metformin exposure.