CI

At a glance

ClinicalIndex Comparison Record
Phase 3Completed· 25 enrolled
Drug / intervention
Metformin +1 moredrug
Likely dose
Metformin 1500 mgfrom 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/NCT03309007
NCT03309007Phase 3Completed

A Double-Blind, Placebo-Controlled Trial of Anti-Aging, Pro-Autophagy Effects of Metformin in Adults With Prediabetes

University of New Mexico·interventional·Posted Oct 13, 2017·Updated Dec 11, 2023

In Brief

A Phase 3 clinical trial evaluating Metformin and Placebo Oral Tablet for PreDiabetes and Aging. Completed, enrolled 25 participants across 1 site.

Detailed Summary

The goal of this pilot and feasibility study is to investigate the effects of a short course of metformin therapy on a surrogate marker of cellular senescence and autophagy among adult patients with prediabetes. The overall hypothesis is that metformin will have beneficial effects on longevity and quality of life by inducing autophagy downstream of activating adenosine monophosphate-activated protein kinase (AMPK) and inhibiting mechanistic target of rapamycin (mTOR) through potential effects of reduced inflammation, reduced degeneration of muscle and tendon tissue, antineoplastic effects, reduced obesity and hyperglycemia, preserved cardiovascular functions, and/or the prevention of neurodegeneration (such as age-associated dementia). This pilot study will address the following aim: Demonstrate that metformin therapy will increase cellular autophagy as an inverse correlate of aging as measured by increases in Microtubule-associated protein 1A/1B-light chain 3 (LC3) scores. Hypothesis 1: In addition to beneficial effects on glycemia, body weight, and body composition, metformin therapy exerts beneficial effects on surrogate measures of autophagy and aging. Primary outcome: Increased levels of LC3 in leukocytes.

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsPreDiabetes, Aging
CountriesUnited States
Collaborators--

Timeline

Phase 3CompletedFinished
201820192020202120222023202420252026
First PostedOct 13, 2017
Enrollment StartSep 1, 2017
Primary CompletionAug 20, 2020
TodayJul 2, 2026
Enrollment to primary: 3.0 yearsPosted 8.7 years ago

Interventions

Metformindrug

Total daily dose titrated up to 1500 mg po q day over the course of 4 weeks and continued for a total exposure of 12 weeks.

Placebo Oral Tabletdrug

Total daily dose titrated up to 1944 mg po q day over the course of 4 weeks and continued for a total exposure of 12 weeks.