Ignite Creation Date:
2025-12-24 @ 10:10 PM
Ignite Modification Date:
2026-01-01 @ 5:40 AM
Study NCT ID:
NCT02728635
Status:
ACTIVE_NOT_RECRUITING
Last Update Posted:
2025-03-13
First Post:
2016-03-24
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Epigenetic Regulation of Human Adipose Tissue Distribution
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': 'D015502', 'term': 'Absorptiometry, Photon'}, {'id': 'D009682', 'term': 'Magnetic Resonance Spectroscopy'}], 'ancestors': [{'id': 'D011859', 'term': 'Radiography'}, {'id': 'D003952', 'term': 'Diagnostic Imaging'}, {'id': 'D019937', 'term': 'Diagnostic Techniques and Procedures'}, {'id': 'D003933', 'term': 'Diagnosis'}, {'id': 'D003720', 'term': 'Densitometry'}, {'id': 'D010783', 'term': 'Photometry'}, {'id': 'D002623', 'term': 'Chemistry Techniques, Analytical'}, {'id': 'D008919', 'term': 'Investigative Techniques'}, {'id': 'D013057', 'term': 'Spectrum Analysis'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'NON_RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'BASIC_SCIENCE', 'interventionModel': 'SINGLE_GROUP'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 27}}, 'statusModule': {'overallStatus': 'ACTIVE_NOT_RECRUITING', 'startDateStruct': {'date': '2016-07', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2025-03', 'completionDateStruct': {'date': '2025-12', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2025-03-12', 'studyFirstSubmitDate': '2016-03-24', 'studyFirstSubmitQcDate': '2016-03-30', 'lastUpdatePostDateStruct': {'date': '2025-03-13', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2016-04-05', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2018-07-11', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Epigenetic marks in abdominal vs gluteal subcutaneous adipose tissue and adipocytes', 'timeFrame': '6 weeks', 'description': "The preadipocytes obtained from biopsies of Abdominal Fat and Gluteofemoral Fat from patients in the 'pears' woman, 'apple' women and men will be cultured by our standard methods in proliferative medium followed by our standard protocol for differentiation into mature adipocytes. We propose to evaluate samples from 3 individuals from each Group to identify a large number of differentially regulated regions genome wide. All the data obtained in vitro in culture cells will be compared with the data obtained from RNA and chromatin isolated from the whole tissue Abdominal fat and Gluteofemoral fat biopsies"}]}, 'oversightModule': {'oversightHasDmc': True}, 'conditionsModule': {'keywords': ['Adipose tissue, epigenetic, abdominal gluteal fat'], 'conditions': ['Obesity']}, 'referencesModule': {'references': [{'pmid': '24239920', 'type': 'BACKGROUND', 'citation': 'Jensen MD, Ryan DH, Apovian CM, Ard JD, Comuzzie AG, Donato KA, Hu FB, Hubbard VS, Jakicic JM, Kushner RF, Loria CM, Millen BE, Nonas CA, Pi-Sunyer FX, Stevens J, Stevens VJ, Wadden TA, Wolfe BM, Yanovski SZ; American College of Cardiology/American Heart Association Task Force on Practice Guidelines; Obesity Society. 2013 AHA/ACC/TOS guideline for the management of overweight and obesity in adults: a report of the American College of Cardiology/American Heart Association Task Force on Practice Guidelines and The Obesity Society. J Am Coll Cardiol. 2014 Jul 1;63(25 Pt B):2985-3023. doi: 10.1016/j.jacc.2013.11.004. Epub 2013 Nov 12. No abstract available.'}, {'pmid': '19960394', 'type': 'BACKGROUND', 'citation': 'McAllister EJ, Dhurandhar NV, Keith SW, Aronne LJ, Barger J, Baskin M, Benca RM, Biggio J, Boggiano MM, Eisenmann JC, Elobeid M, Fontaine KR, Gluckman P, Hanlon EC, Katzmarzyk P, Pietrobelli A, Redden DT, Ruden DM, Wang C, Waterland RA, Wright SM, Allison DB. Ten putative contributors to the obesity epidemic. Crit Rev Food Sci Nutr. 2009 Nov;49(10):868-913. doi: 10.1080/10408390903372599.'}, {'pmid': '25411583', 'type': 'BACKGROUND', 'citation': 'Roberson L, Shaharyar S, Aneni E, Freitas W, Blaha M, Agatston A, Blumenthal R, Santos RD, Feiz H, Nasir K, Sposito A. The prevalence of the metabolically healthy obese phenotype in an aging population and its association with subclinical cardiovascular disease: The Brazilian study on healthy aging. Diabetol Metab Syndr. 2014 Nov 7;6(1):121. doi: 10.1186/1758-5996-6-121. eCollection 2014.'}, {'pmid': '24400816', 'type': 'BACKGROUND', 'citation': 'Roberson LL, Aneni EC, Maziak W, Agatston A, Feldman T, Rouseff M, Tran T, Blaha MJ, Santos RD, Sposito A, Al-Mallah MH, Blankstein R, Budoff MJ, Nasir K. Beyond BMI: The "Metabolically healthy obese" phenotype & its association with clinical/subclinical cardiovascular disease and all-cause mortality -- a systematic review. BMC Public Health. 2014 Jan 8;14:14. doi: 10.1186/1471-2458-14-14.'}, {'pmid': '17403720', 'type': 'BACKGROUND', 'citation': 'de Koning L, Merchant AT, Pogue J, Anand SS. Waist circumference and waist-to-hip ratio as predictors of cardiovascular events: meta-regression analysis of prospective studies. Eur Heart J. 2007 Apr;28(7):850-6. doi: 10.1093/eurheartj/ehm026. Epub 2007 Apr 2.'}, {'pmid': '19724291', 'type': 'BACKGROUND', 'citation': 'Qiao Q, Nyamdorj R. 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Fetal nutrition and cardiovascular disease in adult life. Lancet. 1993 Apr 10;341(8850):938-41. doi: 10.1016/0140-6736(93)91224-a.'}, {'pmid': '8436255', 'type': 'BACKGROUND', 'citation': 'Barker DJ, Hales CN, Fall CH, Osmond C, Phipps K, Clark PM. Type 2 (non-insulin-dependent) diabetes mellitus, hypertension and hyperlipidaemia (syndrome X): relation to reduced fetal growth. Diabetologia. 1993 Jan;36(1):62-7. doi: 10.1007/BF00399095.'}, {'pmid': '19095460', 'type': 'BACKGROUND', 'citation': 'Muhlhausler B, Smith SR. Early-life origins of metabolic dysfunction: role of the adipocyte. Trends Endocrinol Metab. 2009 Mar;20(2):51-7. doi: 10.1016/j.tem.2008.10.006. Epub 2008 Dec 16.'}, {'pmid': '15459241', 'type': 'BACKGROUND', 'citation': 'Armitage JA, Khan IY, Taylor PD, Nathanielsz PW, Poston L. Developmental programming of the metabolic syndrome by maternal nutritional imbalance: how strong is the evidence from experimental models in mammals? 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Epub 2014 May 23.'}, {'pmid': '23150689', 'type': 'BACKGROUND', 'citation': 'Karastergiou K, Fried SK, Xie H, Lee MJ, Divoux A, Rosencrantz MA, Chang RJ, Smith SR. Distinct developmental signatures of human abdominal and gluteal subcutaneous adipose tissue depots. J Clin Endocrinol Metab. 2013 Jan;98(1):362-71. doi: 10.1210/jc.2012-2953. Epub 2012 Nov 12.'}, {'pmid': '14709204', 'type': 'BACKGROUND', 'citation': 'Boston RC, Stefanovski D, Moate PJ, Sumner AE, Watanabe RM, Bergman RN. MINMOD Millennium: a computer program to calculate glucose effectiveness and insulin sensitivity from the frequently sampled intravenous glucose tolerance test. Diabetes Technol Ther. 2003;5(6):1003-15. doi: 10.1089/152091503322641060.'}, {'pmid': '3281434', 'type': 'BACKGROUND', 'citation': 'Livesey G, Elia M. Estimation of energy expenditure, net carbohydrate utilization, and net fat oxidation and synthesis by indirect calorimetry: evaluation of errors with special reference to the detailed composition of fuels. Am J Clin Nutr. 1988 Apr;47(4):608-28. doi: 10.1093/ajcn/47.4.608.'}, {'pmid': '17287467', 'type': 'BACKGROUND', 'citation': 'Shadid S, Koutsari C, Jensen MD. Direct free fatty acid uptake into human adipocytes in vivo: relation to body fat distribution. Diabetes. 2007 May;56(5):1369-75. doi: 10.2337/db06-1680. Epub 2007 Feb 7.'}, {'pmid': '22955991', 'type': 'BACKGROUND', 'citation': 'Landt SG, Marinov GK, Kundaje A, Kheradpour P, Pauli F, Batzoglou S, Bernstein BE, Bickel P, Brown JB, Cayting P, Chen Y, DeSalvo G, Epstein C, Fisher-Aylor KI, Euskirchen G, Gerstein M, Gertz J, Hartemink AJ, Hoffman MM, Iyer VR, Jung YL, Karmakar S, Kellis M, Kharchenko PV, Li Q, Liu T, Liu XS, Ma L, Milosavljevic A, Myers RM, Park PJ, Pazin MJ, Perry MD, Raha D, Reddy TE, Rozowsky J, Shoresh N, Sidow A, Slattery M, Stamatoyannopoulos JA, Tolstorukov MY, White KP, Xi S, Farnham PJ, Lieb JD, Wold BJ, Snyder M. ChIP-seq guidelines and practices of the ENCODE and modENCODE consortia. Genome Res. 2012 Sep;22(9):1813-31. doi: 10.1101/gr.136184.111.'}, {'pmid': '34394195', 'type': 'DERIVED', 'citation': 'Divoux A, Eroshkin A, Erdos E, Sandor K, Osborne TF, Smith SR. DNA Methylation as a Marker of Body Shape in Premenopausal Women. Front Genet. 2021 Jul 29;12:709342. doi: 10.3389/fgene.2021.709342. eCollection 2021.'}], 'seeAlsoLinks': [{'url': 'http://www.tri-md.org', 'label': 'Translational Research Institute for Metabolism and Diabetes'}]}, 'descriptionModule': {'briefSummary': 'The purpose of this study is to collect data to help researchers better understand the different ways that women or men store fat (apple shape versus pear shape).'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT'], 'maximumAge': '45 Years', 'minimumAge': '18 Years', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Age 18-45 years inclusive;\n* BMI 23-35 kg/m2 inclusive;\n* HbA1C \\<6.0%;\n* Weight stable (± 3 kg) during the 3 months prior to enrollment;\n* Women must be \\> 9 months post-partum;\n* Able to provide written, informed consent.\n\nExclusion Criteria:\n\n* Postmenopausal women\n* Women with an oophorectomy\n* Fasting plasma glucose \\> 126 mg/dL, or diagnosis with Type 2 Diabetes (T2DM)\n* Untreated or symptomatic thyroid disease.\n* Aminotransferase or aspartate aminotransferase \\> 3x upper limit of laboratory reference range, or known diagnosis of liver disease.\n* Creatinine \\> 2x upper limit of laboratory reference range, or known diagnosis of kidney disease.\n* Uncontrolled hypertension (BP \\> 140 systolic or \\> 90 diastolic)\n* New onset (\\<3 months on a stable regime) use of oral contraceptives or hormone replacement therapy.\n* History of drug or alcohol abuse (\\> 3 drinks per day) within the last 5 years, or psychiatric disease prohibiting adherence to study protocol. Current drug use may be determine by plasma or urine drug screens.\n* History of cancer within the last 5 years (skin cancers, with the exception of melanoma, may be acceptable).\n* History of organ transplant.\n* Myocardial Infarction within the last 6 months.\n* Current treatment with blood thinners or antiplatelet medications that cannot be safely stopped for biopsy and testing procedures.\n* History of HIV, active Hepatitis B or C or tuberculosis\n* Presence of clinically significant abnormalities on EKG.\n* Current smokers (smoking within the past 3 months).\n* Use of any medications known to influence glucose, fat and/or energy metabolism within the last 3 months (eg. growth hormone therapy, glucocorticoids \\[steroids\\], etc.)\n* Other chronic or acute illness that might affect study results / interpretation in the opinion of the clinical\n* Other items related to procedural risk (outlined below) such as bleeding disorder, claustrophobia, etc.\n* Elevated high sensitivity c-reactive protein or known active infection.\n* There are some implants which are MR compatible (safe) but would cause artifacts which could obscure our ability to measure an organ, e.g. full braces may negate the ability to measure brain size.'}, 'identificationModule': {'nctId': 'NCT02728635', 'acronym': 'Eiffel 2', 'briefTitle': 'Epigenetic Regulation of Human Adipose Tissue Distribution', 'organization': {'class': 'OTHER', 'fullName': 'AdventHealth Translational Research Institute'}, 'officialTitle': 'Epigenetic Regulation of Human Adipose Tissue Distribution', 'orgStudyIdInfo': {'id': 'TRIMDFH 869496'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'ACTIVE_COMPARATOR', 'label': "Group A- Women- Healthy 'pears'", 'description': 'This group will consist of healthy women with a BMI between 23 and 35 kg/m2 as a waist-to-hip ratio of 0.78 or less.', 'interventionNames': ['Other: Dual-energy X-ray absorptiometry (DEXA)/ Magnetic resonance imaging (MRI) and Magnetic resonance spectroscopy (MRS)', 'Procedure: Adipose tissue biopsies', 'Other: FSIGTT/ RMR']}, {'type': 'ACTIVE_COMPARATOR', 'label': "Group B- Women- Healthy 'apples'", 'description': 'The group will consist of healthy women with a BMI between 23 and 35 kg/m2 as a waist-to-hip ratio of 0.85 or more.', 'interventionNames': ['Other: Dual-energy X-ray absorptiometry (DEXA)/ Magnetic resonance imaging (MRI) and Magnetic resonance spectroscopy (MRS)', 'Procedure: Adipose tissue biopsies', 'Other: FSIGTT/ RMR']}, {'type': 'ACTIVE_COMPARATOR', 'label': "Group C- Men- Healthy 'apples'", 'description': 'The group will consist of men with a BMI between 23 and 35 kg/m2.', 'interventionNames': ['Other: Dual-energy X-ray absorptiometry (DEXA)/ Magnetic resonance imaging (MRI) and Magnetic resonance spectroscopy (MRS)', 'Procedure: Adipose tissue biopsies', 'Other: FSIGTT/ RMR']}], 'interventions': [{'name': 'Dual-energy X-ray absorptiometry (DEXA)/ Magnetic resonance imaging (MRI) and Magnetic resonance spectroscopy (MRS)', 'type': 'OTHER', 'description': 'A DEXA scan for body composition will also be completed. After a MRI safety screening a whole body MRI for the volumetric measurement of visceral fat, subcutaneous fat, liver, kidneys, heart, brain, skeletal muscle and intramuscular adipose tissue (IMAT) and hepatic lipid by MRS will be performed. Whole body imaging will include low resolution positioning images, followed by several sets of 3D images which will be digitally connected to create a 3D image the entire length of the body. The liver spectroscopy will be performed using PRESS (point resolved spectroscopy) and STEAM (Stimulated Echo Acquisition Mode) sequence during the same imaging session, using the whole body images for positioning.', 'armGroupLabels': ["Group A- Women- Healthy 'pears'", "Group B- Women- Healthy 'apples'", "Group C- Men- Healthy 'apples'"]}, {'name': 'Adipose tissue biopsies', 'type': 'PROCEDURE', 'description': 'Two biopsies will be performed to collect fat tissue from the abdomen and thigh region.', 'armGroupLabels': ["Group A- Women- Healthy 'pears'", "Group B- Women- Healthy 'apples'", "Group C- Men- Healthy 'apples'"]}, {'name': 'FSIGTT/ RMR', 'type': 'OTHER', 'description': 'Insertion of two intravenous (IV) catheters for performing a Frequently Sampled Intravenous Glucose Tolerance Test (FSIGTT) to measure the acute insulin response to glucose (AIRg) and insulin sensitivity (Si) will be performed. Resting metabolic rate (RMR) will be used to measure metabolic flexibility. Point of care blood glucose measurements will be taken frequently to ensure safety.', 'armGroupLabels': ["Group A- Women- Healthy 'pears'", "Group B- Women- Healthy 'apples'", "Group C- Men- Healthy 'apples'"]}]}, 'contactsLocationsModule': {'locations': [{'zip': '32804', 'city': 'Orlando', 'state': 'Florida', 'country': 'United States', 'facility': 'Translational Research Institute for Metabolism and Diabetes', 'geoPoint': {'lat': 28.53834, 'lon': -81.37924}}], 'overallOfficials': [{'name': 'Steven R Smith, MD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Study Principal Investigator'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'AdventHealth Translational Research Institute', 'class': 'OTHER'}, 'collaborators': [{'name': 'Sanford-Burnham Medical Research Institute', 'class': 'OTHER'}], 'responsibleParty': {'type': 'SPONSOR'}}}}