Phase 3
Completed N=25
A Double-Blind, Placebo-Controlled Trial of Anti-Aging, Pro-Autophagy Effects of Metformin in Adults With Prediabetes
Source: ClinicalTrials.gov NCT03309007 ↗Enrolled (actual)
25
Serious AEs
0.0%
Results posted
Dec 2023
Primary outcomePrimary: Change in Leucocyte LC3 Score — 0.1; -1.8 Fold Change (Arbitrary Units)
◆ Published Evidence
No publication linked
No peer-reviewed publication reporting this trial's results has been linked yet. This can indicate results are unpublished — a known publication-bias signal. We re-check periodically.
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.
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Change in Leucocyte LC3 Score |
0.1; -1.8 | — |
Eligibility Criteria
Inclusion Criteria
- Adults with prediabetes (defined as an A1c of 5.7-6.4%)
- BMI between 27 and 40 kg/m2 (inclusive).
Exclusion Criteria
- Prior treatment with metformin or other diabetes medications,
- Pregnancy,
- Significant renal dysfunction (Serum Creatinine > 1.3 mg/dl for women, > 1.4 mg/dl for men),
- Severe hepatic dysfunction (aspartate amnotransferease [AST] or alanine aminotransferase [ALT] > 3 times the upper limit of normal),
- Ongoing alcohol or substance abuse,
- Inflammatory bowel disease,
- Ongoing glucocorticoid therapy,
- Or inability to render informed consent.
Data sourced from ClinicalTrials.gov (NCT03309007). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication. Informational only — not medical advice.