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NCT04264897 · ClinicalTrials.gov registry record · Phase 3
Antecedent Metabolic Health and Metformin Aging Study
A Phase 3 study, sponsored by Oklahoma Medical Research Foundation.
- Completed
- Registry status
- Phase 3
- Development phase
- 166
- Enrollment target
NCT04264897 is a Phase 3 study that has completed, run by Oklahoma Medical Research Foundation. The registered enrollment target is 166 participants.
The verdict
NCT04264897, a Phase 3 study, has completed, sponsored by Oklahoma Medical Research Foundation.
- COMPLETED
- Registry status
- Phase 3
- Development phase
- 166 participants
- Enrollment target
Study Summary
Aging is the number one risk factor for the majority of chronic diseases. There are no pharmaceutical treatments to slow aging and prolong healthspan. The anti-diabetic drug metformin is considered a likely pharmaceutical candidate to slow aging. In this study, the investigators hypothesize that metformin treatment in subjects free of type 2 diabetes will improve insulin sensitivity and glucoregulation in insulin resistant individuals, but will decrease insulin sensitivity and glucoregulation in insulin sensitive subjects. Further, the investigators hypothesize that long-term metformin treatment will remodel mitochondria in a way that decreases mitochondrial function in subjects that are insulin sensitive, but improves mitochondrial function in subjects that are insulin resistant. The investigators will use a dual-site, 12- week drug intervention trial performed in a double-blind, placebo-controlled manner on 148 subjects recruited from two separate sites (Oklahoma Medical Research Foundation (OMRF) and University of Wisconsin-Madison (UWM)). After consent and initial subject screening for chronic disease, subjects will be stratified to insulin sensitive (IS) or insulin resistant (IR) groups. Over a 12- week intervention, half of each group will take metformin and half will take a placebo. Pre- and post--intervention, subjects will complete a series of procedures to assess insulin sensitivity, glucose regulation, and biomarkers of aging. The same subjects will provide a skeletal muscle biopsy pre-- and post-intervention to assess the change in mitochondrial function and mitochondrial remodeling with and without metformin treatment. By completion of this project, the investigators expect to provide evidence that helps further delineate who may benefit from metformin treatment to slow aging.
Interventions
- DRUG Metformin
- DRUG Placebo oral tablet
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 166 participants |
| Start Date | 2020-07-29 |
| Est. Completion | 2025-03-12 |
| Phase | Phase 3 |
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Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT04264897
The ClinicalTrials.gov registry entry for NCT04264897 describes a study currently listed as completed, categorized as Phase 3. The registered enrollment target is 166 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is Oklahoma Medical Research Foundation, which has 12 total studies on file at ClinicalTrials.gov.
The record links to 0 conditions, and to 2 interventions - of which Metformin is the first listed.
NCT04264897 reports 0 study locations.
Frequently Asked Questions
What is clinical trial NCT04264897 about?
NCT04264897 is a clinical study titled "Antecedent Metabolic Health and Metformin Aging Study". Aging is the number one risk factor for the majority of chronic diseases. There are no pharmaceutical treatments to slow aging and prolong healthspan. The anti-diabetic drug metformin is considered a likely pharmaceutical candidate to slow aging. In this study, the investigators hypothesize that met...
What is the current status of trial NCT04264897?
This trial is currently completed. It is a Phase 3 study. The enrollment target is 166 participants. The study started on 2020-07-29. Estimated completion is 2025-03-12.
What interventions are being tested in trial NCT04264897?
The interventions under investigation include: Metformin (DRUG), Placebo oral tablet (DRUG).
Who is sponsoring clinical trial NCT04264897?
This trial is sponsored by Oklahoma Medical Research Foundation, which has 12 total clinical trials registered on ClinicalTrials.gov.
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