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Study Title Principal Investigator
Effects of Sitagliptin on Arterial Vasoreactivity and Proatherogenic Mediators in Obesity
APPROACH: Overview of Study Design: This is a double-masked, randomized, placebo-controlled pilot study of treatment sitagliptin (100mg/day) to suppress monocyte/macrophage activation in obese non-diabetic participants. 16 abdominally obese18-40 year-old largely minorities will be randomized 3:1 to receive sitagliptin (N=12) or matching placebo (N=4) daily for 28 days. Eligibility Criteria for the Study Cohort: Based on prior studies conducted by the investigators, approximately 60-70% of participants enrolled will be Hispanics and African Americans. Both minorities have increased prevalence of insulin resistance (IR) at young ages. In their prior studies, insulin resistance (HOMA-IR* ≥3.0) had a predictive value of 88% for crown like structure in abdominal fat (a surrogate for fat inflammation); the inclusion criterion for IR will assure that most study subjects will have abdominal fat inflammation. * homeostatic method of analysis-insulin resistance Inclusion Criteria 1. Age 18-40 years of age 2. Stable weight (no change >3% in prior 6 months) 3. Waist circumference ≥102cm for men; ≥88cm for women 4. Fasting plasma glucose 100-125, HgbA1C 5.7-6.4% or HOMA-IR* ≥3.0 Exclusion Criteria: 1. Regular use of a non-steroidal anti-inflammatory drug (NSAID); unwilling to stop NSAID drug 2. On statin or other prescription anti-inflammatory drugs 3. Diabetes or clinically evident cardiovascular disease 4. Smoking daily or consuming >200g alcohol/day Study participants will be adults 18-40 years of age to exclude older persons with irreversible atherosclerosis (e.g. calcified, stenotic plaque) or subclinical arterial thrombus which release inflammatory mediators. Persons with Type 2 diabetes (a myocardial infarction equivalent) and those receiving "statins" (also potent anti-inflammatory drugs) will be excluded, thereby further excluding participants with advanced atherosclerosis. The goal is to identify and study persons with abdominal obesity and inflammation at a younger age as a potential target population for pre-emptive anti-inflammatory therapy to prevent serious CVD events over ensuing years. Outcome Measures: 1. Change in arterial vasoreactivity measured and quantified by ultrasound assessment of brachial artery flow mediated dilation and carotid stiffness (elasticity and distensibility). 2. Change in measures of inflammation in intra-abdominal adipose tissue: 1. M1 pro-inflammatory macrophages and M2 anti-inflammatory macrophages by fluorescent activated cell sorting. 2. Ex vivo secretion of inflammatory mediators from macrophages fractions. 3. Change in systemic pro-inflammatory/pro-atherogenic markers and insulin resistance.
Recruiting | Atherosclerosis | Not Multisite
Fred Sattler
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Assessing the Efficacy of Secukinumab in Psoriasis Patients
The purpose of the study is to see if secukinumab has an effect on fatty tissue beneath the skin and on skin inflammation in patients with psoriasis. This study will also look at blood tests, or “markers,” that could help identify risk for heart disease and metabolic diseases like diabetes or cardiometabolic disease. Secukinumab (Cosentyx®) is a prescription medicine that has been approved by the U.S. Food and Drug Administration (FDA) for the treatment of moderate to severe plaque psoriasis, psoriatic arthritis, and ankylosing spondylitis in adults.
Recruiting | psoriasis | Not Multisite
April W. Armstrong, MD MPH
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Carotid Revascularization and Medical Management for Asymptomatic Carotid Stenosis Trial
Prevention of stroke involves managing and treating risk factors. Most strokes are caused when blood flow to a portion of the brain is blocked. One place this often happens is in the carotid artery. This blockage is called atherosclerosis or hardening of the arteries. The purpose of this trial is to determine the best way to prevent strokes in people who have a high amount of blockage of their carotid artery but no stroke symptoms related to that blockage. Each eligible participant will be evaluated to determine which procedure(s) is best for him/her. All participants will receive intensive medical treatment. In addition, participants will be randomized to receive the selected procedure or not. The trial will be conducted in the United States and Canada by physicians carefully selected on their ability to perform the procedures at low risk. Another key component of the trial is that important stroke risk factors, including hypertension, diabetes, high cholesterol, cigarette smoking, physical activity, and diet will be managed intensively. Participants will remain in the study for 4 years.
Recruiting | Atherosclerosis | Multisite
Thomas Brott
A Phase III, Double-blind, Randomized, Placebo-controlled, Multicenter Study to Asses the Safety and Efficacy of VM202 to Treat Chronic Nonhealing Foot Ulcers in Diabetic Patients With Concomitant Peripheral Arterial Disease (PAD)
A phase III, randomized, double-blind, placebo-controlled, multicenter, 7-month study designed to assess the safety and efficacy of intramuscular (IM) injections in the calf of VM202 in patients with chronic nonhealing foot ulcers. Three hundred patients will be randomized in a 2:1 ratio of VM202 or placebo injections: - Active -VM202 + standard of care - 200 patients - Control - Placebo (VM202 Vehicle) + standard of care - 100 patients
Recruiting | Atherosclerosis | Site Unknown
Emerson Perin
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