Diabetes Risk Clinical Trial
Official title:
Using Salsalate to Target Adipocyte Macrophage Infiltration and Reverse Metabolic Disease Risk in Obese Hispanic Young Adults
Background: The prevalence of obesity has increased throughout the last three decades due to
genetic, metabolic, behavioral, and environmental factors. Obesity and high-fat western
diets activate inflammatory processes, which promote development of insulin resistance as
well as other metabolic complications. Increasing obesity rates are a major public health
concern in the Hispanic population due to the large number of Hispanics suffering from
obesity. Based on preliminary data, we propose a double-blind randomized clinical trial of
Salsalate therapy in obese Hispanic young adults. Salsalate treatment shows promise for
decreasing inflammation under conditions of weight stability by reducing macrophage
infiltration of adipocytes. Hispanics have the greatest amount of visceral adipose tissue
(VAT), liver fat, and inflammation when compared to other ethnic groups, thereby increasing
the potential for treatment effects in this high-risk population.
Purpose: The purpose of this study is to demonstrate through a "proof-of-concept" trial that
Salsalate induced reductions in adipose tissue inflammation are possible under conditions of
weight stability.
Methodology: We will recruit obese Hispanic young adults (18 - 35 years) from hospitals,
clinics, and community centers. Study Endpoints: Primary outcomes will be macrophage
infiltration as assessed by the presence of crown-like structures (CLS) in subcutaneous
adipose tissue (SAT) biopsies, liver fat, insulin sensitivity, and fasting glucose. We will
also assess plasma levels of monocyte chemoattractant protein (MCP)-1, tumor necrosis factor
(TNF)-α, interleukin (IL)-1, C-reactive protein (CRP), and SAT gene expression of nuclear
factor kB (NF-kB) and insulin signaling pathways.
Intervention and Follow-up: Participants will be randomly assigned to four weeks of
treatment with Salsalate (4 g/d) or placebo and will be studied under weight maintenance
conditions. These measures will enable us to determine if Salsalate treatment is capable of
reducing adipose tissue inflammation and related metabolic outcomes in the absence of weight
loss.
n/a
Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Primary Purpose: Basic Science