Medical Information Only. Always consult your healthcare provider before enrolling in any clinical trial.
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: Completed Phase 2 study, sponsored by Rutgers University.
NCT03355469 is a Phase 2 study that has completed, run by Rutgers University. The registered enrollment target is 91 participants, below the 133-participant average among 30,622 other Phase 2 trials with a reported enrollment target (32% lower). According to ClinicalTrials.gov, the official US trial registry.
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.
Primary Outcome
Endothelial function assessed as a percentage change in brachial artery diameter from baseline to deflation (5 minutes after artery occlusion by blood pressure cuff inflation). Delta = Week 16 - Week 0. Higher values and positive change scores following the intervention indicate a better outcome.
Interventions
- DRUG Placebo
- DRUG Metformin
- BEHAVIORAL High Intensity Exercise
- BEHAVIORAL Low Intensity Exercise
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 91 participants |
| Start Date | 2017-08-07 |
| Est. Completion | 2024-05-23 |
| Phase | Phase 2 |
What the finished NCT03355469 record still lists
NCT03355469 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 91 participants, a relatively small participant target, below the 133-participant average among 30,622 other Phase 2 trials with a reported enrollment target (32% lower).
The record links to 0 conditions, and to 4 interventions - of which Placebo is the first listed.
NCT03355469 does not publish any study locations in the registry export this page uses.
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.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT03355469's enrollment target sits among peer trials
91 771st of 2000 higher than 1,229 of 2,000 other Phase 2 trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Phase 2 trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.
Source ClinicalTrials.gov registry export · 2026-08-08
Nationwide trials with similar profiles
Cross-condition peers matched on enrollment target and registry start date, not the same-condition list above.
Similar enrollment target
- NCT02671448 · 91 participants · NA
Pilot Trial of Homebound Stem Cell Transplantation
- NCT04835857 · 91 participants
Comparison of Cuff-Less Wrist Wearable Blood Pressure Device to Cuff Based Blood Pressure Measuring Devices
- NCT05184842 · 91 participants · Phase 2
Metabolically Optimized, Non-cytotoxic Low Dose Weekly Decitabine/Venetoclax in MDS and AML
- NCT05685173 · 91 participants · Phase 1
A Trial to Study if REGN5837 in Combination With Odronextamab is Safe for Adult Participants With Aggressive B-cell Non-Hodgkin Lymphomas
Similar registry start date
- NCT05962346 · started 2026-12 · NA
Fetal Endoscopic Tracheal Occlusion for Congenital Diaphragmatic Hernia
- NCT07125183 · started 2026-12 · Phase 2
Study on Efficacy and Tolerability of Weekly Doxorubicin in Elderly Patients With Advanced or Metastatic Leiomyosarcoma
- NCT07292298 · started 2026-11 · Phase 2
Phase 2 Single-Arm Rectal Cancer Brachytherapy for Patients With Low-Lying Residual Adenocarcinoma After Total Neoadjuvant Therapy to Improve Organ Preservation Rates
- NCT04263285 · started 2026-10 · NA
Treatment of Depression Post-SCI