Using Salsalate to Target Adipocyte Macrophage Infiltration

Completed · Phase 1 · Has a placebo group

Conditions studied: Diabetes Risk

In brief

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.

Key facts

Study ID: NCT02130804
Run by: University of Southern California
People needed: 30
Starts: 2011-07-01
Expected to finish: 2013-10-01
Last updated by the study team: 2014-05-05

Who can join

Age: 18 and older, up to 35. Sex: any. Healthy volunteers: accepted.

You may qualify if…

Obese (body mass index >30 kg/m\^2)
Hispanic males and females age 18-35 years

You may not qualify if…

Women with hemoglobin <11.5 g/dL or men with hemoglobin <12.5 g/dL will be excluded
AST / ALT >2 times the upper limit of normal
Evidence of any liver disease other than non-alcoholic steatosis
Diabetes
Diagnosis of any disease that is known to influence insulin action and secretion
Current or past involvement in any weight loss, exercise, or sports program in the six months prior to participation
Use of medication known to influence body composition or fat distribution (e.g. Cushing syndrome)
History of renal disease
Use of non-steroidal anti-inflammatory drugs (NSAIDs)
Chicken pox, flu, or influenza infection
Those taking high doses of vitamin C, antacids (containing Ca2+ or Mg+2), or taking Warfarin
Hypertension
Allergies to Salsalate, aspirin or other NSAIDs
History of peptic ulcer or upper GI bleeding
A positive pregnancy test or current lactation
Has smoked greater than 100 cigarettes in their lifetime and now smokes everyday or some days
Drinks greater than 200 g/day of alcohol
Those with a waist circumference (or widest part of body measurement) greater than or equal to 185 cm due to MRI size restrictions

Where it is running

University of Southern California Diabetes Obesity Research Institute (DORI) — Los Angeles, California, United States
University of Southern California, Clinical Trials Unit (CTU) — Los Angeles, California, United States

Full record on ClinicalTrials.gov

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