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NCT03355469 · ClinicalTrials.gov registry record · Phase 2

Exercise Dose and Metformin for Vascular Health in Metabolic Syndrome

A Phase 2 study, sponsored by Rutgers University.

Completed
Registry status
Phase 2
Development phase
91
Enrollment target

NCT03355469 is a Phase 2 study that has completed, run by Rutgers University. The registered enrollment target is 91 participants.

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The verdict

NCT03355469, a Phase 2 study, has completed, sponsored by Rutgers University.

COMPLETED
Registry status
Phase 2
Development phase
91 participants
Enrollment target

Study Summary

Health organizations recommend exercise in an intensity based manner to promote cardiovascular adaptation and prevent disease. Metformin is a common anti-diabetes medication that reduces future type 2 diabetes and cardiovascular disease (CVD) risk. However, the optimal dose of exercise to be combined with metformin for vascular health remains unknown. The purpose of this study is to evaluate whether combining high or low intensity exercise with metformin has the potential to outperform either exercise intensity alone on blood flow across the arterial tree as well as impact insulin action in individuals with metabolic syndrome. Identification of such outcomes will indicate 1) whether and how metformin should be combined with physical activity for CVD prevention, 2) provide the first indication of whether exercise intensity reduces CVD risk via multi-level vasculature function vs. metabolic insulin action, and 3) provide a rational early treatment for people with metabolic syndrome to prevent/treat type 2 diabetes and CVD.

Interventions

  • DRUG Placebo
  • DRUG Metformin
  • BEHAVIORAL High Intensity Exercise
  • BEHAVIORAL Low Intensity Exercise

Trial Details

FieldValue
Enrollment Target 91 participants
Start Date 2017-08-07
Est. Completion 2024-05-23
Phase Phase 2

Sponsor

Rutgers University

18 total trials

What the Registry Record Tells You About NCT03355469

The ClinicalTrials.gov registry entry for NCT03355469 describes a study currently listed as completed, categorized as Phase 2. The registered enrollment target is 91 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is Rutgers University, which has 18 total studies on file at ClinicalTrials.gov.

The record links to 0 conditions, and to 4 interventions - of which Placebo is the first listed.

NCT03355469 reports 0 study locations.

Frequently Asked Questions

What is clinical trial NCT03355469 about?

NCT03355469 is a clinical study titled "Exercise Dose and Metformin for Vascular Health in Metabolic Syndrome". Health organizations recommend exercise in an intensity based manner to promote cardiovascular adaptation and prevent disease. Metformin is a common anti-diabetes medication that reduces future type 2 diabetes and cardiovascular disease (CVD) risk. However, the optimal dose of exercise to be combine...

What is the current status of trial NCT03355469?

This trial is currently completed. It is a Phase 2 study. The enrollment target is 91 participants. The study started on 2017-08-07. Estimated completion is 2024-05-23.

What interventions are being tested in trial NCT03355469?

The interventions under investigation include: Placebo (DRUG), Metformin (DRUG), High Intensity Exercise (BEHAVIORAL), Low Intensity Exercise (BEHAVIORAL).

Who is sponsoring clinical trial NCT03355469?

This trial is sponsored by Rutgers University, which has 18 total clinical trials registered on ClinicalTrials.gov.

Data sourced from official public datasets. See our methodology for details. Retrieved and formatted by PlainTrial Editorial

Every figure on PlainTrial is rendered directly from the ClinicalTrials.gov registry, no number is typed in by an editor. This page mirrors this trial's own ClinicalTrials.gov registry record, live from the dataset. See our editorial standards & corrections policy, the methodology behind these numbers, or report a data error.