Using Salsalate to Target Adipocyte Macrophage Infiltration

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.

Recruitment Status

COMPLETED

Clinical Phase

PHASE1

Total Enrollment

30 participants

Study Classification

INTERVENTIONAL

Study Start Date

2011-07-31

Study Completion Date

2013-10-31

Brief Summary

Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.

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.

Related Clinical Trials

Explore similar clinical trials based on study characteristics and research focus.

Meal-regulated Substrate Metabolism, Influence of Obesity and IL-6

NCT04687540

Obesity Healthy

COMPLETED NA

Brown Adipose Tissue Activity in Response to Semaglutide Administered to Obese Subjects.

NCT05419726

Obesity

RECRUITING

Efficacy and Safety of Zenoctil in Reducing Body Weight

NCT01423617

Overweight

COMPLETED PHASE3

Weight Loss In Obese Subjects Taking Either GW869682 Or Placebo 3 Times Per Day For 12 Weeks

NCT00297180

Obesity

COMPLETED PHASE2

Study to Assess the Effects and Safety of ZGN-1061 in Overweight and Obese Participants With Type 2 Diabetes

NCT03254368

Type 2 Diabetes Mellitus Overweight and Obesity

COMPLETED PHASE2

Detailed Description

Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.

Conditions

See the medical conditions and disease areas that this research is targeting or investigating.

Diabetes Risk

Study Design

Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.

Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

BASIC_SCIENCE

Blinding Strategy

QUADRUPLE

Participants Caregivers Investigators Outcome Assessors

Study Groups

Review each arm or cohort in the study, along with the interventions and objectives associated with them.

Salsalate

Salsalate (4 g/day)

Group Type EXPERIMENTAL

Salsalate (4 g/day)

Intervention Type DRUG

Given orally twice daily

Placebo

Placebo (4 g/day)

Group Type PLACEBO_COMPARATOR

Placebo (4 g/day)

Intervention Type DRUG

Given orally twice daily

Interventions

Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.

Salsalate (4 g/day)

Given orally twice daily

Intervention Type DRUG

Placebo (4 g/day)

Given orally twice daily

Intervention Type DRUG

Other Intervention Names

Discover alternative or legacy names that may be used to describe the listed interventions across different sources.

Salicylate Inactive control

Eligibility Criteria

Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.

Inclusion Criteria

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

Exclusion Criteria

* 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

Minimum Eligible Age

18 Years

Maximum Eligible Age

35 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Responsible Party

Identify the individual or organization who holds primary responsibility for the study information submitted to regulators.

Michael I. Goran

Professor in the Departments of Preventive Medicine, Physiology & Biophysics and Pediatrics in the Keck School of Medicine, Director of the Childhood Obesity Research Center

Responsibility Role PRINCIPAL_INVESTIGATOR