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NCT03309007 · ClinicalTrials.gov registry record · Phase 3
A Double-Blind, Placebo-Controlled Trial of Anti-Aging, Pro-Autophagy Effects of Metformin in Adults With Prediabetes
A Phase 3 study, sponsored by University of New Mexico.
- Completed
- Registry status
- Phase 3
- Development phase
- 25
- Enrollment target
NCT03309007 is a Phase 3 study that has completed, run by University of New Mexico. The registered enrollment target is 25 participants.
The verdict
NCT03309007, a Phase 3 study, has completed, sponsored by University of New Mexico.
- COMPLETED
- Registry status
- Phase 3
- Development phase
- 25 participants
- Enrollment target
Study 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.
Interventions
- DRUG Metformin
- DRUG Placebo Oral Tablet
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 25 participants |
| Start Date | 2017-09-01 |
| Est. Completion | 2020-08-20 |
| Phase | Phase 3 |
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Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT03309007
The ClinicalTrials.gov registry entry for NCT03309007 describes a study currently listed as completed, categorized as Phase 3. The registered enrollment target is 25 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is University of New Mexico, which has 168 total studies on file at ClinicalTrials.gov.
The record links to 0 conditions, and to 2 interventions - of which Metformin is the first listed.
NCT03309007 reports 0 study locations.
Frequently Asked Questions
What is clinical trial NCT03309007 about?
NCT03309007 is a clinical study titled "A Double-Blind, Placebo-Controlled Trial of Anti-Aging, Pro-Autophagy Effects of Metformin in Adults With Prediabetes". 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 q...
What is the current status of trial NCT03309007?
This trial is currently completed. It is a Phase 3 study. The enrollment target is 25 participants. The study started on 2017-09-01. Estimated completion is 2020-08-20.
What interventions are being tested in trial NCT03309007?
The interventions under investigation include: Metformin (DRUG), Placebo Oral Tablet (DRUG).
Who is sponsoring clinical trial NCT03309007?
This trial is sponsored by University of New Mexico, which has 168 total clinical trials registered on ClinicalTrials.gov.
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