Ignite Creation Date:
2025-12-24 @ 9:07 PM
Ignite Modification Date:
2026-01-26 @ 3:45 PM
Study NCT ID:
NCT02130804
Status:
COMPLETED
Last Update Posted:
2014-05-05
First Post:
2014-04-29
Is Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Using Salsalate to Target Adipocyte Macrophage Infiltration
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D009765', 'term': 'Obesity'}], 'ancestors': [{'id': 'D050177', 'term': 'Overweight'}, {'id': 'D044343', 'term': 'Overnutrition'}, {'id': 'D009748', 'term': 'Nutrition Disorders'}, {'id': 'D009750', 'term': 'Nutritional and Metabolic Diseases'}, {'id': 'D001835', 'term': 'Body Weight'}, {'id': 'D012816', 'term': 'Signs and Symptoms'}, {'id': 'D013568', 'term': 'Pathological Conditions, Signs and Symptoms'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'C014182', 'term': 'salicylsalicylic acid'}, {'id': 'D012459', 'term': 'Salicylates'}], 'ancestors': [{'id': 'D062385', 'term': 'Hydroxybenzoates'}, {'id': 'D001565', 'term': 'Benzoates'}, {'id': 'D000146', 'term': 'Acids, Carbocyclic'}, {'id': 'D002264', 'term': 'Carboxylic Acids'}, {'id': 'D009930', 'term': 'Organic Chemicals'}, {'id': 'D006880', 'term': 'Hydroxy Acids'}, {'id': 'D001555', 'term': 'Benzene Derivatives'}, {'id': 'D006841', 'term': 'Hydrocarbons, Aromatic'}, {'id': 'D006844', 'term': 'Hydrocarbons, Cyclic'}, {'id': 'D006838', 'term': 'Hydrocarbons'}, {'id': 'D010636', 'term': 'Phenols'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE1'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'QUADRUPLE', 'whoMasked': ['PARTICIPANT', 'CARE_PROVIDER', 'INVESTIGATOR', 'OUTCOMES_ASSESSOR']}, 'primaryPurpose': 'BASIC_SCIENCE', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 30}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2011-07'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2014-05', 'completionDateStruct': {'date': '2013-10', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2014-05-01', 'studyFirstSubmitDate': '2014-04-29', 'studyFirstSubmitQcDate': '2014-05-01', 'lastUpdatePostDateStruct': {'date': '2014-05-05', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2014-05-05', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2013-10', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Change in plasma glucose levels over a 2-hour oral glucose tolerance test', 'timeFrame': '4 weeks', 'description': 'Glucose following 4 weeks of treatment with salsalate (4 g/day) or placebo. A 2-hour oral glucose tolerance test will be performed at baseline and 4 weeks to measure changes in plasma glucose levels.'}, {'measure': 'Change in adipose tissue inflammation', 'timeFrame': '4 weeks', 'description': 'Adipose tissue inflammation following 4 weeks of treatment with salsalate (4 g/day) or placebo. Adipose tissue inflammation will be determined from abdominal subcutaneous adipose tissue biopsies performed at baseline and 4 weeks.'}, {'measure': 'Change in systemic markers of inflammation', 'timeFrame': '4 weeks', 'description': 'Systemic markers of inflammation following treatment with salsalate (4 g/day) or placebo. Fasting blood samples will be taken at baseline and 4 weeks to measure systemic markers of inflammation.'}, {'measure': 'Change in plasma insulin levels over a 2-hour oral glucose tolerance test', 'timeFrame': '4 weeks', 'description': 'Insulin following 4 weeks of treatment with salsalate (4 g/day) or placebo. A 2-hour oral glucose tolerance test will be performed at baseline and 4 weeks to measure changes in plasma insulin levels.'}, {'measure': 'Change in plasma fasting free fatty acid levels', 'timeFrame': '4 weeks', 'description': 'Fasting free fatty acids (FFA) following 4 weeks of treatment with salsalate (4 g/day) or placebo. Fasting blood samples will be taken at baseline and 4 weeks to measure changes in plasma fasting FFA.'}, {'measure': 'Change in plasma C-peptide levels over a 2-hour oral glucose tolerance test', 'timeFrame': '4 weeks', 'description': 'C-peptide following 4 weeks of treatment with salsalate (4 g/day) or placebo. A 2-hour oral glucose tolerance test will be performed at baseline and 4 weeks to measure changes in plasma C-peptide levels.'}], 'secondaryOutcomes': [{'measure': 'Change in body composition', 'timeFrame': '4 weeks', 'description': 'Changes in body composition following 4 weeks of treatment with salsalate (4 g/day) or placebo. A DEXA scan will be performed at baseline and 4 weeks to measure any potential changes in body composition (body fat and lean tissue mass).'}, {'measure': 'Change in ectopic fat', 'timeFrame': '4 weeks', 'description': 'Changes in ectopic fat following 4 weeks of treatment with salsalate (4 g/day) or placebo. A 3-Tesla whole abdominal MRI scan will be performed at baseline and 4 weeks to measure any potential changes in ectopic fat.'}, {'measure': 'Change in diet', 'timeFrame': '4 weeks', 'description': 'Changes in diet following 4 weeks of treatment with salsalate (4 g/day) or placebo. A 24-hour diet recall will be performed at baseline and 4 weeks to measure any potential changes in diet.'}, {'measure': 'Change in physical activity', 'timeFrame': '4 weeks', 'description': 'Changes in physical activity following 4 weeks of treatment with salsalate (4 g/day) or placebo. A Godin-Shephard Leisure-Time Physical Activity questionnaire will be performed at baseline and 4 weeks to measure any potential changes in physical activity.'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'keywords': ['Obesity', 'Adipose tissue inflammation', 'Salsalate', 'Hispanics'], 'conditions': ['Diabetes Risk']}, 'referencesModule': {'references': [{'pmid': '23370525', 'type': 'BACKGROUND', 'citation': 'Goldfine AB, Conlin PR, Halperin F, Koska J, Permana P, Schwenke D, Shoelson SE, Reaven PD. A randomised trial of salsalate for insulin resistance and cardiovascular risk factors in persons with abnormal glucose tolerance. Diabetologia. 2013 Apr;56(4):714-23. doi: 10.1007/s00125-012-2819-3. Epub 2013 Jan 31.'}, {'pmid': '20231565', 'type': 'BACKGROUND', 'citation': 'Goldfine AB, Fonseca V, Jablonski KA, Pyle L, Staten MA, Shoelson SE; TINSAL-T2D (Targeting Inflammation Using Salsalate in Type 2 Diabetes) Study Team. The effects of salsalate on glycemic control in patients with type 2 diabetes: a randomized trial. Ann Intern Med. 2010 Mar 16;152(6):346-57. doi: 10.7326/0003-4819-152-6-201003160-00004.'}, {'pmid': '19337387', 'type': 'BACKGROUND', 'citation': 'Goldfine AB, Silver R, Aldhahi W, Cai D, Tatro E, Lee J, Shoelson SE. Use of salsalate to target inflammation in the treatment of insulin resistance and type 2 diabetes. Clin Transl Sci. 2008 May;1(1):36-43. doi: 10.1111/j.1752-8062.2008.00026.x.'}, {'pmid': '17959861', 'type': 'BACKGROUND', 'citation': 'Fleischman A, Shoelson SE, Bernier R, Goldfine AB. Salsalate improves glycemia and inflammatory parameters in obese young adults. Diabetes Care. 2008 Feb;31(2):289-94. doi: 10.2337/dc07-1338. Epub 2007 Oct 24.'}, {'pmid': '19104769', 'type': 'BACKGROUND', 'citation': 'Koska J, Ortega E, Bunt JC, Gasser A, Impson J, Hanson RL, Forbes J, de Courten B, Krakoff J. The effect of salsalate on insulin action and glucose tolerance in obese non-diabetic patients: results of a randomised double-blind placebo-controlled study. Diabetologia. 2009 Mar;52(3):385-93. doi: 10.1007/s00125-008-1239-x. Epub 2008 Dec 23.'}, {'pmid': '22784842', 'type': 'BACKGROUND', 'citation': 'Faghihimani E, Aminorroaya A, Rezvanian H, Adibi P, Ismail-Beigi F, Amini M. Reduction of insulin resistance and plasma glucose level by salsalate treatment in persons with prediabetes. Endocr Pract. 2012 Nov-Dec;18(6):826-33. doi: 10.4158/EP12064.OR.'}, {'pmid': '21938543', 'type': 'BACKGROUND', 'citation': 'Faghihimani E, Aminorroaya A, Rezvanian H, Adibi P, Ismail-Beigi F, Amini M. Salsalate improves glycemic control in patients with newly diagnosed type 2 diabetes. Acta Diabetol. 2013 Aug;50(4):537-43. doi: 10.1007/s00592-011-0329-2. Epub 2011 Sep 22.'}]}, 'descriptionModule': {'briefSummary': '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.\n\nPurpose: 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.\n\nMethodology: 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.\n\nIntervention 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.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT'], 'maximumAge': '35 Years', 'minimumAge': '18 Years', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Obese (body mass index \\>30 kg/m\\^2)\n* Hispanic males and females age 18-35 years\n\nExclusion Criteria:\n\n* Women with hemoglobin \\<11.5 g/dL or men with hemoglobin \\<12.5 g/dL will be excluded\n* AST / ALT \\>2 times the upper limit of normal\n* Evidence of any liver disease other than non-alcoholic steatosis\n* Diabetes\n* Diagnosis of any disease that is known to influence insulin action and secretion\n* Current or past involvement in any weight loss, exercise, or sports program in the six months prior to participation\n* Use of medication known to influence body composition or fat distribution (e.g. Cushing syndrome)\n* History of renal disease\n* Use of non-steroidal anti-inflammatory drugs (NSAIDs)\n* Chicken pox, flu, or influenza infection\n* Those taking high doses of vitamin C, antacids (containing Ca2+ or Mg+2), or taking Warfarin\n* Hypertension\n* Allergies to Salsalate, aspirin or other NSAIDs\n* History of peptic ulcer or upper GI bleeding\n* A positive pregnancy test or current lactation\n* Has smoked greater than 100 cigarettes in their lifetime and now smokes everyday or some days\n* Drinks greater than 200 g/day of alcohol\n* Those with a waist circumference (or widest part of body measurement) greater than or equal to 185 cm due to MRI size restrictions'}, 'identificationModule': {'nctId': 'NCT02130804', 'acronym': 'TAMI', 'briefTitle': 'Using Salsalate to Target Adipocyte Macrophage Infiltration', 'organization': {'class': 'OTHER', 'fullName': 'University of Southern California'}, 'officialTitle': 'Using Salsalate to Target Adipocyte Macrophage Infiltration and Reverse Metabolic Disease Risk in Obese Hispanic Young Adults', 'orgStudyIdInfo': {'id': 'HS-11-00017'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Salsalate', 'description': 'Salsalate (4 g/day)', 'interventionNames': ['Drug: Salsalate (4 g/day)']}, {'type': 'PLACEBO_COMPARATOR', 'label': 'Placebo', 'description': 'Placebo (4 g/day)', 'interventionNames': ['Drug: Placebo (4 g/day)']}], 'interventions': [{'name': 'Salsalate (4 g/day)', 'type': 'DRUG', 'otherNames': ['Salicylate'], 'description': 'Given orally twice daily', 'armGroupLabels': ['Salsalate']}, {'name': 'Placebo (4 g/day)', 'type': 'DRUG', 'otherNames': ['Inactive control'], 'description': 'Given orally twice daily', 'armGroupLabels': ['Placebo']}]}, 'contactsLocationsModule': {'locations': [{'zip': '90089', 'city': 'Los Angeles', 'state': 'California', 'country': 'United States', 'facility': 'University of Southern California Diabetes Obesity Research Institute (DORI)', 'geoPoint': {'lat': 34.05223, 'lon': -118.24368}}, {'zip': '90089', 'city': 'Los Angeles', 'state': 'California', 'country': 'United States', 'facility': 'University of Southern California, Clinical Trials Unit (CTU)', 'geoPoint': {'lat': 34.05223, 'lon': -118.24368}}], 'overallOfficials': [{'name': 'Michael I Goran, PhD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'University of Southern California'}, {'name': 'Tanya L Alderete', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'University of Southern California'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'University of Southern California', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Professor in the Departments of Preventive Medicine, Physiology & Biophysics and Pediatrics in the Keck School of Medicine, Director of the Childhood Obesity Research Center', 'investigatorFullName': 'Michael I. Goran', 'investigatorAffiliation': 'University of Southern California'}}}}