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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: Completed Phase 2 study, sponsored by University of Southern California.
NCT02576288 is a Phase 2 study that has completed, run by University of Southern California. The registered enrollment target is 21 participants, below the 133-participant average among 30,622 other Phase 2 trials with a reported enrollment target (84% lower). According to ClinicalTrials.gov, the official US trial registry.
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.
Primary Outcome
To ascertain effects of sitagliptin vs placebo on endothelial function (brachial artery flow) and structural measure of atherosclerosis (carotid stiffness)
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 |
What the finished NCT02576288 record still lists
NCT02576288 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 21 participants, a relatively small participant target, below the 133-participant average among 30,622 other Phase 2 trials with a reported enrollment target (84% lower).
The record links to 0 conditions, and to 2 interventions - of which Placebo is the first listed.
NCT02576288 does not publish any study locations in the registry export this page uses.
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.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT02576288's enrollment target sits among peer trials
21 1794th of 2000 higher than 196 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
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