Ignite Creation Date:
2025-12-24 @ 3:00 PM
Ignite Modification Date:
2025-12-26 @ 1:46 AM
Study NCT ID:
NCT03289559
Status:
COMPLETED
Last Update Posted:
2017-09-21
First Post:
2017-09-18
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Effects of Testosterone and Fat Utilization
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'interventionBrowseModule': {'meshes': [{'id': 'C092464', 'term': 'LHRH, Ac-Nal(1)-Cpa(2)-Trp(3)-Arg(6)-Ala(10)-'}, {'id': 'D047072', 'term': 'Aromatase Inhibitors'}], 'ancestors': [{'id': 'D065088', 'term': 'Steroid Synthesis Inhibitors'}, {'id': 'D004791', 'term': 'Enzyme Inhibitors'}, {'id': 'D045504', 'term': 'Molecular Mechanisms of Pharmacological Action'}, {'id': 'D020228', 'term': 'Pharmacologic Actions'}, {'id': 'D020164', 'term': 'Chemical Actions and Uses'}, {'id': 'D004965', 'term': 'Estrogen Antagonists'}, {'id': 'D006727', 'term': 'Hormone Antagonists'}, {'id': 'D006730', 'term': 'Hormones, Hormone Substitutes, and Hormone Antagonists'}, {'id': 'D045505', 'term': 'Physiological Effects of Drugs'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'DOUBLE', 'whoMasked': ['PARTICIPANT', 'INVESTIGATOR']}, 'primaryPurpose': 'BASIC_SCIENCE', 'interventionModel': 'CROSSOVER'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 13}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2006-01-01', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2017-09', 'completionDateStruct': {'date': '2014-01-01', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2017-09-19', 'studyFirstSubmitDate': '2017-09-18', 'studyFirstSubmitQcDate': '2017-09-19', 'lastUpdatePostDateStruct': {'date': '2017-09-21', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2017-09-21', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2011-01-01', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Dietary fat tracer for storage of meal derived fatty acids', 'timeFrame': '4 weeks', 'description': '50 uCi of \\[1-14C\\] oleic acid administered with an inpatient test meal'}]}, 'oversightModule': {'oversightHasDmc': True, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Healthy', 'Volunteers']}, 'referencesModule': {'references': [{'pmid': '29380951', 'type': 'DERIVED', 'citation': 'Rynders CA, Schmidt SL, Bergouignan A, Horton TJ, Bessesen DH. Effects of short-term sex steroid suppression on dietary fat storage patterns in healthy males. Physiol Rep. 2018 Jan;6(2):e13533. doi: 10.14814/phy2.13533.'}]}, 'descriptionModule': {'briefSummary': 'Evidence is accumulating that there are sex differences in energy and substrate metabolism. The positive or negative consequences of such metabolic differences between men and women need to be evaluated with respect to health outcomes. The importance of aberrant lipid metabolism in metabolic diseases such as obesity, diabetes and cardiovascular disease, makes understanding the distinction between "normal" vs aberrant critical to future treatment and prevention strategies. Sex differences in the effects of catecholamines on lipid metabolism and substrate oxidation in non-obese, healthy individuals, have been consistently observed. In addition, distinct differences in men and women exist in the distribution of body fat, with men typically having greater central adiposity than women. Accumulation of fat in the abdomen is associated with an increased risk for metabolic abnormalities such as hyperlipidemia and insulin resistance. In the current study, therefore, the role of testosterone in determining the sex differences in catecholamine mediated substrate metabolism and deposition of dietary fat into upper versus lower body adipose tissue depots will be addressed.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT'], 'maximumAge': '45 Years', 'minimumAge': '25 Years', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* normal weight (BMI of 23-29.9 kg/m2)\n* not be highly trained (\\< 5hrs of moderate intensity, planned exercise per week).\n\nExclusion Criteria:\n\n* Patients will be excluded if they have one or more of the following out-of-range values measured on a fasting blood sample:\n* glucose \\<65 or \\> 110 mg/dl,\n* insulin \\> 20 uU/ml,\n* thyroid stimulating hormone \\<0.5 or \\>5.0 uU/ml,\n* growth hormone \\>2.5 ng/ml.\n* Subjects who may be:\n* anemic (hemoglobin \\< 14.5 g/dl men ),\n* have abnormal liver function tests:\n\n * alanine amino transferase \\> 47 U/l,\n * aspartate aminotransferase, \\> 47 U/l,\n * alkaline phosphatase \\<39 or \\>117 U/l) or\n * creatinine (\\<0.6 or \\>1.1 mg/dl).'}, 'identificationModule': {'nctId': 'NCT03289559', 'briefTitle': 'Effects of Testosterone and Fat Utilization', 'organization': {'class': 'OTHER', 'fullName': 'University of Colorado, Denver'}, 'officialTitle': 'Testosterone Effects on Systemic Lipolysis and Whole Body Lipid Utilization', 'orgStudyIdInfo': {'id': '06-0010'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'NO_INTERVENTION', 'label': 'Control'}, {'type': 'PLACEBO_COMPARATOR', 'label': 'GnRH antagonist + Placebo Gel', 'interventionNames': ['Drug: GnRH antagonist', 'Drug: Aromatase Inhibitors']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'GnRH antagonist + Testosterone Gel', 'interventionNames': ['Drug: GnRH antagonist', 'Drug: Aromatase Inhibitors', 'Drug: Testosterone gel']}], 'interventions': [{'name': 'GnRH antagonist', 'type': 'DRUG', 'armGroupLabels': ['GnRH antagonist + Placebo Gel', 'GnRH antagonist + Testosterone Gel']}, {'name': 'Aromatase Inhibitors', 'type': 'DRUG', 'armGroupLabels': ['GnRH antagonist + Placebo Gel', 'GnRH antagonist + Testosterone Gel']}, {'name': 'Testosterone gel', 'type': 'DRUG', 'armGroupLabels': ['GnRH antagonist + Testosterone Gel']}]}, 'contactsLocationsModule': {'overallOfficials': [{'name': 'Daniel Bessesen, MD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'University of Colorado, Denver'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'University of Colorado, Denver', 'class': 'OTHER'}, 'responsibleParty': {'type': 'SPONSOR'}}}}