Ignite Creation Date:
2025-12-24 @ 4:44 PM
Ignite Modification Date:
2025-12-27 @ 2:38 AM
Study NCT ID:
NCT01900366
Status:
COMPLETED
Last Update Posted:
2016-09-19
First Post:
2013-07-11
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Pilot Study for Noninvasive Spectroscopic Detection of Adipose Tissue Inflammation in Obesity
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'}]}}, 'protocolSection': {'designModule': {'bioSpec': {'retention': 'SAMPLES_WITHOUT_DNA', 'description': 'Adipose tissue'}, 'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'PROSPECTIVE', 'observationalModel': 'CASE_CONTROL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 14}, 'patientRegistry': False}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2013-08'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2016-09', 'completionDateStruct': {'date': '2016-08', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2016-09-16', 'studyFirstSubmitDate': '2013-07-11', 'studyFirstSubmitQcDate': '2013-07-11', 'lastUpdatePostDateStruct': {'date': '2016-09-19', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2013-07-16', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2016-08', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Classification of adipose tissue as healthy or inflamed by Raman Spectroscopy', 'timeFrame': '1 day', 'description': 'Classification of adipose tissue as healthy or inflamed by Raman Spectroscopy'}], 'secondaryOutcomes': [{'measure': 'Steady state oxygenation at the site of tissue biopsy by Diffuse Reflectance Spectroscopy', 'timeFrame': '1 day', 'description': 'Steady state oxygenation at the site of tissue biopsy by Diffuse Reflectance Spectroscopy'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'keywords': ['Obesity', 'Healthy Volunteers'], 'conditions': ['Obesity']}, 'descriptionModule': {'briefSummary': 'This study will test the potential of two techniques using light properties of adipose tissue to diagnose crown-like structures and inflammation to be compared with pathologic examination of adipose tissue biopsies from ongoing clinical studies.', 'detailedDescription': 'Adipose tissue (fat) inflammation is emerging as an important harbinger of disease development including Type 2 diabetes, heart disease and potentially cancer. The hallmark feature of adipose tissue inflammation is the crown-like structure, a dying fat cell surrounded by immune cells attempting to clear the damage. Current methods for detecting adipose tissue inflammation rely on invasive procedures such as fat biopsies. We propose developing methods that use the light reflection properties of inflamed adipose tissue as a potential non-invasive method to detect adipose tissue inflammation.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '70 Years', 'minimumAge': '18 Years', 'samplingMethod': 'PROBABILITY_SAMPLE', 'studyPopulation': 'Healthy Volunteer and obese subjects', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\n-Subjects currently enrolled in a current Rockefeller University study who will be undergoing adipose tissue biopsies as part of the study protocol\n\nExclusion Criteria:\n\n-History of any skin disease'}, 'identificationModule': {'nctId': 'NCT01900366', 'briefTitle': 'Pilot Study for Noninvasive Spectroscopic Detection of Adipose Tissue Inflammation in Obesity', 'organization': {'class': 'OTHER', 'fullName': 'Rockefeller University'}, 'officialTitle': 'Pilot Study for Noninvasive Spectroscopic Detection of Adipose Tissue Inflammation in Obesity', 'orgStudyIdInfo': {'id': 'JAL-0809'}}, 'armsInterventionsModule': {'armGroups': [{'label': 'Obese subjects for fat biopsy', 'description': '10 patients recruited during fat biopsies for sample collection', 'interventionNames': ['Procedure: Fat Biopsy']}, {'label': 'Lean controls for fat biopsy', 'description': '5 Lean controls will be recruited', 'interventionNames': ['Procedure: Fat Biopsy']}], 'interventions': [{'name': 'Fat Biopsy', 'type': 'PROCEDURE', 'description': 'Fat biopsy', 'armGroupLabels': ['Lean controls for fat biopsy', 'Obese subjects for fat biopsy']}]}, 'contactsLocationsModule': {'locations': [{'zip': '10065', 'city': 'New York', 'state': 'New York', 'country': 'United States', 'facility': 'The Rockefeller University', 'geoPoint': {'lat': 40.71427, 'lon': -74.00597}}], 'overallOfficials': [{'name': 'Jose Aleman, MD PhD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Rockefeller Univesrity'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Rockefeller University', 'class': 'OTHER'}, 'collaborators': [{'name': 'Weill Medical College of Cornell University', 'class': 'OTHER'}], 'responsibleParty': {'type': 'SPONSOR'}}}}