Ignite Creation Date:
2025-12-24 @ 9:46 PM
Ignite Modification Date:
2025-12-25 @ 7:25 PM
Study NCT ID:
NCT06096532
Status:
RECRUITING
Last Update Posted:
2025-03-19
First Post:
2023-09-26
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Adipose Tissue Blood Flow in Aging Humans
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'NON_RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'BASIC_SCIENCE', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 24}}, 'statusModule': {'overallStatus': 'RECRUITING', 'startDateStruct': {'date': '2024-01-15', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2024-12', 'completionDateStruct': {'date': '2025-11-30', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2025-03-17', 'studyFirstSubmitDate': '2023-09-26', 'studyFirstSubmitQcDate': '2023-10-19', 'lastUpdatePostDateStruct': {'date': '2025-03-19', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2023-10-23', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2025-11-30', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Adipose tissue blood flow', 'timeFrame': 'Baseline, pre-intervention fasting and immediately following 75 gm oral glucose load', 'description': 'blood flow will be measured in the upper body subcutaneous adipose tissue using 133 Xenon washout and reported as blood flow in ml/min/100g adipose tissue.'}], 'secondaryOutcomes': [{'measure': 'Genomic alterations', 'timeFrame': 'Baseline, pre-intervention fasting and immediately following 75 gm oral glucose load', 'description': 'RNA-Seq from adipose tissue biopsies'}]}, 'oversightModule': {'isUsExport': False, 'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Healthy', 'Aging']}, 'referencesModule': {'seeAlsoLinks': [{'url': 'https://www.mayo.edu/research/clinical-trials', 'label': 'Mayo Clinic Clinical Trials'}]}, 'descriptionModule': {'briefSummary': 'The goal of this basic science clinical trial is to understand whether adipose tissue blood flow changes between younger and older healthy adults.\n\nThe main question\\[s\\] it aims to answer are:\n\n* Is basal and nutrient responsive adipose tissue blood flow (ATBF) different between younger and older adults\n* What molecular and systemic signatures related to adipose tissue blood flow are altered between these two groups.\n\nParticipants will undergo measurements of adipose tissue blood flow using the xenon washout technique, undergo 2 abdominal subcutaneous adipose tissue biopsies, and drink a sugary drink.', 'detailedDescription': "On Visit 1, volunteers will provide written informed consent (and urine pregnancy test for women of childbearing age), complete a Dual x-ray absorptiometry scan, baseline labs (comprehensive metabolic panel) and a cardiopulmonary exercise test. Participants will arrive fasted at 08:00, and urine pregnancy test for women of childbearing age administered and an intravenous catheter will be placed. Following 30min of supine rest, baseline venous blood samples will be collected. ATBF will be assessed on participants' left abdomen first by measurement of blood flow using 133Xenon washout method. Immediately thereafter, an abdominal adipose tissue biopsy of the left side will be performed but ≥6 cm distant from location of 133Xenon injections. Subjects will them consume 75 gm glucose; because ATBF peaks 30-60 minutes following ingestion of glucose, ATBF measures will start 30 minutes after ingestion on the contralateral side followed immediately by plasma measures and another adipose tissue biopsy. During ATBF measurements, brachial blood pressure will be assessed in two-minute intervals."}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '80 Years', 'minimumAge': '18 Years', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion criteria\n\n* Within the ages of 18-35 years or 65-80 years at time of study visit\n* BMI between 20-25.0 kg/m2.\n\nExclusion criteria:\n\n* Presence of diagnosed cardiometabolic diseases (e.g., Type 2 diabetes, hypertension, Heart Failure)\n* Taking prescription anticoagulants\n* Taking prescriptions or supplements that effect adipose tissue metabolism (i.e., statins, Thiazolidinediones, niacin, atypical antipsychotics, or fish oil)\n* Pregnant or nursing\n* Inability to provide written informed consent\n* Smokers'}, 'identificationModule': {'nctId': 'NCT06096532', 'briefTitle': 'Adipose Tissue Blood Flow in Aging Humans', 'organization': {'class': 'OTHER', 'fullName': 'Mayo Clinic'}, 'officialTitle': 'Adipose Tissue Blood Flow in Aging Humans', 'orgStudyIdInfo': {'id': '23-004200'}, 'secondaryIdInfos': [{'id': 'UL1TR002377', 'link': 'https://reporter.nih.gov/quickSearch/UL1TR002377', 'type': 'NIH'}]}, 'armsInterventionsModule': {'armGroups': [{'type': 'OTHER', 'label': 'Older Adults', 'interventionNames': ['Other: 75 gm oral glucose load']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'Younger Adults', 'interventionNames': ['Other: 75 gm oral glucose load']}], 'interventions': [{'name': '75 gm oral glucose load', 'type': 'OTHER', 'description': 'Consumption of 75 gm oral glucose load in order to test nutrient responsiveness', 'armGroupLabels': ['Older Adults', 'Younger Adults']}]}, 'contactsLocationsModule': {'locations': [{'zip': '55905', 'city': 'Rochester', 'state': 'Minnesota', 'status': 'RECRUITING', 'country': 'United States', 'contacts': [{'name': 'Kelli A Lytle, PhD', 'role': 'CONTACT', 'email': 'lytle.kelli@mayo.edu', 'phone': '507-255-1488'}], 'facility': 'Mayo Clinic Minnesota', 'geoPoint': {'lat': 44.02163, 'lon': -92.4699}}], 'overallOfficials': [{'name': 'Kelli Lytle, PhD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Mayo Clinic'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Mayo Clinic', 'class': 'OTHER'}, 'collaborators': [{'name': 'National Center for Advancing Translational Sciences (NCATS)', 'class': 'NIH'}], 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Principal Investigator', 'investigatorFullName': 'Kelli A. Lytle', 'investigatorAffiliation': 'Mayo Clinic'}}}}