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NCT04087655 · ClinicalTrials.gov registry record · NA
Microvascular Dysfunction in Obesity
A NA study of Obesity and Endothelial Dysfunction, sponsored by Florida State University.
- Recruiting
- Registry status
- NA
- Development phase
- 25
- Enrollment target
- 1
- Study location
NCT04087655: Recruiting NA study of Obesity and Endothelial Dysfunction, sponsored by Florida State University.
NCT04087655 is a NA study of Obesity and Endothelial Dysfunction that is actively recruiting participants, run by Florida State University. The registered enrollment target is 25 participants, below the 819-participant average among 1,053 other Obesity trials with a reported enrollment target (97% lower). The trial reports 1 study location across 1 state. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT04087655, a NA study of Obesity and Endothelial Dysfunction, is actively recruiting participants, sponsored by Florida State University.
- RECRUITING
- Registry status
- NA
- Development phase
- 25 participants
- Enrollment target
- 1
- Study location
Study Summary
Impaired endothelial function is observed in disease states related to obesity, such as atherosclerosis, coronary artery disease, and diabetes. Reactive oxygen species (ROS) production and resultant oxidative stress contribute to the development of these obesity-related diseases. The enzyme NADPH-oxidase is a major source of oxidative stress within the vasculature, and has been linked with the Metabolic Syndrome. In the investigator's previously funded studies, the investigators demonstrated for the first time that: 1) in vivo ROS were elevated in skeletal muscle of obese as compared to lean or overweight human subjects, 2) perfusion of the NADPH-oxidase inhibitor apocynin locally into muscle normalized ROS levels and reversed local microvascular endothelial dysfunction in the obese individuals, and 3) aerobic exercise training was effective at attenuating in vivo hydrogen peroxide production and reversing microvascular endothelial dysfunction in the obese individuals. The investigators will investigate in this R15 renewal application the mechanism of exercise training-induced alterations in ROS production and action on endothelial dysfunction in obesity using our newly developed microdialysis methodology of monitoring ROS production, in combination with analysis of muscle biopsy samples obtained before and after our previously tested 8-week intervention of aerobic interval exercise training. The objectives of this study are to determine the impact of in vivo NADPH oxidase activity on endothelial function in obese individuals, and to determine the mechanism of training-induced improvements in endothelial function. The investigator's unique microdialysis methodology will allow monitoring of microvascular/endothelial function and ROS generation, as well as the administration of pharmacological agents directly into muscle. The central hypothesis is that it is upregulation of both mitochondrial ROS and NADPH oxidase-derived ROS that results in endothelial dysfunction in
Primary Outcome
reactive oxygen species as indicated by H2O2 concentration measured with microdialysis
Conditions Studied
Interventions
- BEHAVIORAL Exercise
Study Locations (1)
Florida
- Florida State University - Tallahassee
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 25 participants |
| Start Date | 2019-11-20 |
| Est. Completion | 2027-05-31 |
| Phase | NA |
What NCT04087655 shows while recruiting
NCT04087655 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 25 participants, a relatively small participant target, below the 819-participant average among 1,053 other Obesity trials with a reported enrollment target (97% lower).
The record links to 2 conditions, with Obesity appearing as the primary indexed condition, and to 1 intervention - of which Exercise is the first listed.
NCT04087655 reports a single indexed study location in Florida.
Frequently Asked Questions
What is clinical trial NCT04087655 about?
NCT04087655 is a clinical study titled "Microvascular Dysfunction in Obesity". Impaired endothelial function is observed in disease states related to obesity, such as atherosclerosis, coronary artery disease, and diabetes. Reactive oxygen species (ROS) production and resultant oxidative stress contribute to the development of these obesity-related diseases. The enzyme NADPH-ox...
What is the current status of trial NCT04087655?
This trial is currently recruiting. It is a NA study. The enrollment target is 25 participants. The study started on 2019-11-20. Estimated completion is 2027-05-31.
What conditions does trial NCT04087655 study?
This clinical trial studies the following conditions: Obesity, Endothelial Dysfunction.
What interventions are being tested in trial NCT04087655?
The interventions under investigation include: Exercise (BEHAVIORAL).
Who is sponsoring clinical trial NCT04087655?
This trial is sponsored by Florida State University, which has 219 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT04087655 being conducted?
This trial has 1 study location across Florida. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
Learn More About Clinical Trials
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Matched on the same primary condition, ranked to surface studies in the same phase first, then by recruiting status, no relevance scoring or editorial curation.
Where NCT04087655's enrollment target sits among peer trials
25 904th of 1053 higher than 146 of 1,053 other Obesity trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Obesity 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
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