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NCT02576288 · ClinicalTrials.gov registry record · Phase 2
Sitagliptin Effects on Arterial Vasculature and Inflammation in Obesity
A Phase 2 study, sponsored by University of Southern California.
- Completed
- Registry status
- Phase 2
- Development phase
- 21
- Enrollment target
NCT02576288 is a Phase 2 study that has completed, run by University of Southern California. The registered enrollment target is 21 participants.
The verdict
NCT02576288, a Phase 2 study, has completed, sponsored by University of Southern California.
- COMPLETED
- Registry status
- Phase 2
- Development phase
- 21 participants
- Enrollment target
Study Summary
Abdominal obesity is a major risk factor for heart attack, stroke, peripheral vascular disease, dementia, cancer and Type 2 diabetes. The central hypothesis for this proposal is that pro-atherogenic mediators emanate from inflammation in deep subcutaneous adipose tissue (dSAT) that are released into the systemic circulation and damage the arterial vasculature. The investigators postulate that inflammation of dSAT, when quantified by macrophage phenotyping/enumeration will be a) closely linked with systemic levels of pro-atherogenic mediators and b) tightly associated with endothelial dysfunction and loss of central arterial elasticity, which are highly predictive of future cardiovascular disease (CVD) complications. These relationships provide the basis for macrophage-targeted therapy to reduce obesity-related inflammation and impaired arterial vasoreactivity. The investigators will evaluate a novel approach using a dipeptidyl peptidase 4 inhibitor (DPP4i) sitagliptin, which blocks signal transduction for monocyte/macrophage activation. Thus, in abdominally obese, 18-40 years-old adults without clinical CVD, the show study is expected to show that sitagliptin versus placebo will: 1. significantly improve early measures of arterial damage (brachial artery endothelial dysfunction and reduced carotid elasticity). 2. significantly attenuate inflammation in dSAT and local production of pro-inflammatory mediators in adipose tissue, which will be associated with decreases in systemic pro-atherogenic mediators that contribute to atherogenesis. Since many obese persons fail to sustain weight loss by lifestyle interventions including diet and exercise, an important public health goal is to identify relatively safe alternative strategies that can be used pre-emptively in "asymptomatic" obese persons when arterial dysfunction and damage is still reversible before atherosclerosis progresses to serious CVD events.
Interventions
- DRUG Placebo
- DRUG Sitagliptin
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 21 participants |
| Start Date | 2016-01 |
| Est. Completion | 2017-12-31 |
| Phase | Phase 2 |
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Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT02576288
The ClinicalTrials.gov registry entry for NCT02576288 describes a study currently listed as completed, categorized as Phase 2. The registered enrollment target is 21 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is University of Southern California, which has 617 total studies on file at ClinicalTrials.gov.
The record links to 0 conditions, and to 2 interventions - of which Placebo is the first listed.
NCT02576288 reports 0 study locations.
Frequently Asked Questions
What is clinical trial NCT02576288 about?
NCT02576288 is a clinical study titled "Sitagliptin Effects on Arterial Vasculature and Inflammation in Obesity". Abdominal obesity is a major risk factor for heart attack, stroke, peripheral vascular disease, dementia, cancer and Type 2 diabetes. The central hypothesis for this proposal is that pro-atherogenic mediators emanate from inflammation in deep subcutaneous adipose tissue (dSAT) that are released into...
What is the current status of trial NCT02576288?
This trial is currently completed. It is a Phase 2 study. The enrollment target is 21 participants. The study started on 2016-01. Estimated completion is 2017-12-31.
What interventions are being tested in trial NCT02576288?
The interventions under investigation include: Placebo (DRUG), Sitagliptin (DRUG).
Who is sponsoring clinical trial NCT02576288?
This trial is sponsored by University of Southern California, which has 617 total clinical trials registered on ClinicalTrials.gov.
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