Ignite Creation Date:
2025-12-25 @ 1:41 AM
Ignite Modification Date:
2025-12-25 @ 11:58 PM
Study NCT ID:
NCT00365794
Status:
COMPLETED
Last Update Posted:
2019-08-26
First Post:
2006-08-16
Is NOT Gene Therapy:
True
Has Adverse Events:
True
Brief Title:
Effects of Testosterone Gel on Carbohydrate and Lipid Metabolism In Elderly Obese Men
Sponsor:
Organization:
Raw JSON
{'hasResults': True, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D009765', 'term': 'Obesity'}, {'id': 'D007333', 'term': 'Insulin Resistance'}, {'id': 'D007006', 'term': 'Hypogonadism'}, {'id': 'D056128', 'term': 'Obesity, Abdominal'}], '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'}, {'id': 'D006946', 'term': 'Hyperinsulinism'}, {'id': 'D044882', 'term': 'Glucose Metabolism Disorders'}, {'id': 'D008659', 'term': 'Metabolic Diseases'}, {'id': 'D006058', 'term': 'Gonadal Disorders'}, {'id': 'D004700', 'term': 'Endocrine System Diseases'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D013739', 'term': 'Testosterone'}], 'ancestors': [{'id': 'D000737', 'term': 'Androstenols'}, {'id': 'D000736', 'term': 'Androstenes'}, {'id': 'D000731', 'term': 'Androstanes'}, {'id': 'D013256', 'term': 'Steroids'}, {'id': 'D000072473', 'term': 'Fused-Ring Compounds'}, {'id': 'D011083', 'term': 'Polycyclic Compounds'}, {'id': 'D045165', 'term': 'Testosterone Congeners'}, {'id': 'D012739', 'term': 'Gonadal Steroid Hormones'}, {'id': 'D042341', 'term': 'Gonadal Hormones'}, {'id': 'D006728', 'term': 'Hormones'}, {'id': 'D006730', 'term': 'Hormones, Hormone Substitutes, and Hormone Antagonists'}]}}, 'resultsSection': {'moreInfoModule': {'pointOfContact': {'email': 'fsattler@usc.edu', 'phone': '323-409-4635', 'title': 'Fred Sattler, MD', 'organization': 'University of Southern California'}, 'certainAgreement': {'piSponsorEmployee': False, 'restrictiveAgreement': False}, 'limitationsAndCaveats': {'description': 'The primary limitation of this small pilot study is that it does not have a control group.\n\nIt is also likely under-powered and thus unable to show significance differences for some measurements.'}}, 'adverseEventsModule': {'timeFrame': '20 weeks for each participant', 'description': 'No serious adverse events occurred.', 'eventGroups': [{'id': 'EG000', 'title': 'Open Label Testosterone Treatment', 'description': 'No serious adverse events occurred\n\nPSA and Framingham CV Disease Risk Score did not increase', 'otherNumAtRisk': 20, 'deathsNumAtRisk': 20, 'otherNumAffected': 1, 'seriousNumAtRisk': 20, 'deathsNumAffected': 0, 'seriousNumAffected': 0}], 'otherEvents': [{'term': 'Skin irritation', 'stats': [{'groupId': 'EG000', 'numAtRisk': 20, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Skin and subcutaneous tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'ACTG'}], 'frequencyThreshold': '5'}, 'outcomeMeasuresModule': {'outcomeMeasures': [{'type': 'PRIMARY', 'title': 'Change in Total Mass and Regional Adipose Adiposiy', 'denoms': [{'units': 'Participants', 'counts': [{'value': '19', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'Single Arm', 'description': 'Open label treatment with each participant serving as his own control. Data is compared before and after treatment.\n\nTopical testosterone (Androgel) 10 g/day: Testosterone therapy for 20 weeks'}], 'classes': [{'title': 'Total body mass', 'categories': [{'measurements': [{'value': '0.3', 'groupId': 'OG000', 'lowerLimit': '-4.8', 'upperLimit': '4.1'}]}]}, {'title': 'Total fat mass', 'categories': [{'measurements': [{'value': '-1.4', 'groupId': 'OG000', 'lowerLimit': '-7.4', 'upperLimit': '2.0'}]}]}, {'title': 'Trunk fat mass', 'categories': [{'measurements': [{'value': '-0.9', 'groupId': 'OG000', 'lowerLimit': '-4.6', 'upperLimit': '0.2'}]}]}, {'title': 'Extremity fat mass', 'categories': [{'measurements': [{'value': '-0.7', 'groupId': 'OG000', 'lowerLimit': '-3.0', 'upperLimit': '2.3'}]}]}], 'analyses': [{'pValue': '0.77', 'groupIds': ['OG000'], 'groupDescription': 'Total body mass', 'statisticalMethod': 't-test, 2 sided', 'nonInferiorityType': 'OTHER'}, {'pValue': '0.003', 'groupIds': ['OG000'], 'groupDescription': 'Total fat mass', 'statisticalMethod': 't-test, 2 sided', 'nonInferiorityType': 'OTHER'}, {'pValue': '0.0007', 'groupIds': ['OG000'], 'groupDescription': 'Statistical analysis is for change in trunk fat mass after 20 weeks of testosterone gel.', 'statisticalMethod': 't-test, 2 sided', 'nonInferiorityType': 'OTHER'}, {'pValue': '0.01', 'groupIds': ['OG000'], 'groupDescription': 'Statistical analysis is for change in extremity fat mass after 20 weeks of testosterone gel.', 'statisticalMethod': 't-test, 2 sided', 'nonInferiorityType': 'OTHER'}], 'paramType': 'MEDIAN', 'timeFrame': 'Baseline to 20 weeks', 'description': 'Change in total body mass, total fat mass, trunk fat, and extremity fat', 'unitOfMeasure': 'kilograms', 'dispersionType': 'Full Range', 'reportingStatus': 'POSTED', 'populationDescription': 'Data for one participant was not available'}, {'type': 'PRIMARY', 'title': 'Change in Hepatic Lipid', 'denoms': [{'units': 'Participants', 'counts': [{'value': '19', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'Single Arm', 'description': 'Open label treatment without masking with each participant serving as his own control. Measurements are compared before and after treatment.\n\nTopical testosterone gel 10 g/day: Testosterone gel therapy for 20 weeks'}], 'classes': [{'categories': [{'measurements': [{'value': '-36', 'groupId': 'OG000', 'lowerLimit': '-84', 'upperLimit': '127'}]}]}], 'analyses': [{'pValue': '0.12', 'groupIds': ['OG000'], 'pValueComment': 'No adjustment in p for multiple comparisons.', 'statisticalMethod': 't-test, 2 sided', 'nonInferiorityType': 'OTHER'}], 'paramType': 'MEDIAN', 'timeFrame': 'Baseline to week 20', 'description': 'Amount of liver fat is highly predictive of insulin resistance. Hepatic fat is measured by MR spectroscopy and adjusted for H2O and results are reported as ratio of these two.', 'unitOfMeasure': 'ratio', 'dispersionType': 'Full Range', 'reportingStatus': 'POSTED', 'populationDescription': 'Data not available for one subject'}, {'type': 'PRIMARY', 'title': 'Intramyocellular Lipid (IMCL)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '15', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'Single Arm', 'description': 'Open label treatment with each participant serving as his own control. Data is compared before and after treatment.\n\nTopical testosterone (Androgel) 10 g/day: Testosterone therapy for 20 weeks'}], 'classes': [{'categories': [{'measurements': [{'value': '-30', 'groupId': 'OG000', 'lowerLimit': '-85', 'upperLimit': '43'}]}]}], 'analyses': [{'pValue': '0.008', 'groupIds': ['OG000'], 'statisticalMethod': 't-test, 2 sided', 'nonInferiorityType': 'OTHER'}], 'paramType': 'MEDIAN', 'timeFrame': 'Baseline to week 20', 'description': 'IMCL is quantified by MR spectroscopy of the anterior tibialis muscle of the leg. The value is adjusted for creatine and reported as a ratio', 'unitOfMeasure': 'ratio', 'dispersionType': 'Full Range', 'reportingStatus': 'POSTED', 'populationDescription': 'data not available for 5 subjects'}, {'type': 'SECONDARY', 'title': 'Change in Percentage of Total Body Fat', 'denoms': [{'units': 'Participants', 'counts': [{'value': '19', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'Single Arm', 'description': 'Open label treatment with each participant serving as his own control. Data is compared before and after treatment.\n\nTopical testosterone (Androgel) 10 g/day: Testosterone therapy for 20 weeks'}], 'classes': [{'categories': [{'measurements': [{'value': '-1.6', 'groupId': 'OG000', 'lowerLimit': '-6.5', 'upperLimit': '0.1'}]}]}], 'analyses': [{'pValue': '0.0002', 'groupIds': ['OG000'], 'pValueComment': 'No adjustment for multiple comparisons.', 'statisticalMethod': 't-test, 2 sided', 'nonInferiorityType': 'OTHER'}], 'paramType': 'MEDIAN', 'timeFrame': 'Baseline and 20 weeks', 'description': 'Percentage of total body fat is quantified by DEXA scanning', 'unitOfMeasure': 'percentage of total body fat', 'dispersionType': 'Full Range', 'reportingStatus': 'POSTED', 'populationDescription': 'Data not available for one subject'}, {'type': 'SECONDARY', 'title': 'Change in Total and Regional Carbohydrate Metabolism During a 2-hr Hyperinsulinemic Euglycemic Clamp and [6,6-2H2] Glucose Studies (Peripheral Glucose Disposal [Rd],Hepatic Glucose Output [HGO])', 'denoms': [{'units': 'Participants', 'counts': [{'value': '20', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'Single Arm', 'description': 'Open label treatment with each participant serving as his own control. Data is compared before and after treatment.\n\nTopical testosterone (Androgel) 10 g/day: Testosterone therapy for 20 weeks'}], 'classes': [{'title': 'Whole body insulin sensitiity', 'categories': [{'measurements': [{'value': '1.05', 'groupId': 'OG000', 'lowerLimit': '-2.44', 'upperLimit': '3.73'}]}]}, {'title': 'hepaic glucose output (HGO)', 'categories': [{'measurements': [{'value': '-0.16', 'groupId': 'OG000', 'lowerLimit': '-2.58', 'upperLimit': '7.49'}]}]}, {'title': 'peripheral glucose disposal (Rd)', 'categories': [{'measurements': [{'value': '1.16', 'groupId': 'OG000', 'lowerLimit': '-3.08', 'upperLimit': '3.85'}]}]}], 'analyses': [{'pValue': '0.04', 'groupIds': ['OG000'], 'groupDescription': 'Statistical analysis for change in whole body insulin sensitivity after treatment with testosterone gel for 20 weeks.', 'statisticalMethod': 't-test, 2 sided', 'nonInferiorityType': 'OTHER'}, {'pValue': '0.59', 'groupIds': ['OG000'], 'groupDescription': 'Statistical analysis for change in hepatic glucose output (measure of central insulin sensitivity) after treatment with testosterone gel for 20 weeks', 'statisticalMethod': 't-test, 2 sided', 'nonInferiorityType': 'OTHER'}, {'pValue': '0.03', 'groupIds': ['OG000'], 'groupDescription': 'Statistical analysis for change in rate of peripheral glucose disposal (test of peripheral insulin sensitivity) after treatment with testosterone gel for 20 weeks', 'statisticalMethod': 't-test, 2 sided', 'nonInferiorityType': 'OTHER'}], 'paramType': 'MEDIAN', 'timeFrame': 'Baseline and 20 weeks', 'description': 'In the final analysis, total and regional carbohydrate metabolism during a 2-hr hyperinsulinemic euglycemic clamp (peripheral glucose disposal \\[Rd\\],hepatic glucose output \\[HGO\\]) were analyzed by mass transfer of glucose during both stages of the clamp relative to insulin levels.', 'unitOfMeasure': 'dL/min per μU/mL', 'dispersionType': 'Full Range', 'reportingStatus': 'POSTED'}, {'type': 'SECONDARY', 'title': 'Change in Skeletal Muscle Mass by DEXA', 'denoms': [{'units': 'Participants', 'counts': [{'value': '20', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'Single Arm', 'description': 'Open label treatment with each participant serving as his own control. Data is compared before and after treatment.\n\nTopical testosterone (Androgel) 10 g/day: Testosterone therapy for 20 weeks'}], 'classes': [{'categories': [{'measurements': [{'value': '1.2', 'groupId': 'OG000', 'lowerLimit': '-1.1', 'upperLimit': '4.8'}]}]}], 'analyses': [{'pValue': '0.0006', 'groupIds': ['OG000'], 'groupDescription': 'Change in DEXA extremity (appendicular) lean tissue, a measure of extremity muscle mass after 20 weeks ot treatent with testosterone gel.', 'statisticalMethod': 't-test, 2 sided', 'nonInferiorityType': 'OTHER'}], 'paramType': 'MEDIAN', 'timeFrame': 'Baselne to 20 weeks', 'description': 'Skeletal muscle mass was assesed by regional DEXA to quantify appendicular lean tissues which is primarily muscle.', 'unitOfMeasure': 'kilograms', 'dispersionType': 'Full Range', 'reportingStatus': 'POSTED'}, {'type': 'SECONDARY', 'title': 'Plasma Lipids', 'denoms': [{'units': 'Participants', 'counts': [{'value': '20', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'Single Arm', 'description': 'Open label treatment with each participant serving as his own control. Data is compared before and after treatment.\n\nTopical testosterone (Androgel) 10 g/day: Testosterone therapy for 20 weeks'}], 'classes': [{'title': 'Fasting triglycerides', 'categories': [{'measurements': [{'value': '-0.33', 'groupId': 'OG000', 'lowerLimit': '-2.70', 'upperLimit': '0.43'}]}]}, {'title': 'Total cholesterol', 'categories': [{'measurements': [{'value': '-0.52', 'groupId': 'OG000', 'lowerLimit': '-1.74', 'upperLimit': '0.88'}]}]}, {'title': 'LDL cholesterol', 'categories': [{'measurements': [{'value': '-0.23', 'groupId': 'OG000', 'lowerLimit': '-1.45', 'upperLimit': '0.70'}]}]}, {'title': 'HDL cholesterol', 'categories': [{'measurements': [{'value': '-0.10', 'groupId': 'OG000', 'lowerLimit': '-0.60', 'upperLimit': '0.05'}]}]}], 'analyses': [{'pValue': '0.02', 'groupIds': ['OG000'], 'groupDescription': 'A change in 20 plasma lipids (fasting triglycerides and lipid fractions) after 20 weeks of treatment with testosterone gel.', 'statisticalMethod': 't-test, 2 sided', 'nonInferiorityType': 'OTHER', 'nonInferiorityComment': 'Test for fasting triglycerides'}, {'pValue': '0.004', 'groupIds': ['OG000'], 'groupDescription': 'A change in 20 plasma lipids (fasting triglycerides and lipid fractions) after 20 weeks of treatment with testosterone gel', 'statisticalMethod': 't-test, 2 sided', 'nonInferiorityType': 'OTHER', 'nonInferiorityComment': 'Test for total cholesterol'}, {'pValue': '.02', 'groupIds': ['OG000'], 'groupDescription': 'nts A change in 20 plasma lipids (fasting triglycerides and lipid fractions) after 20 weeks of treatment with testosterone gel', 'statisticalMethod': 't-test, 2 sided', 'nonInferiorityType': 'OTHER', 'nonInferiorityComment': 'Test for LDL cholesterol'}, {'pValue': '0.004', 'groupIds': ['OG000'], 'groupDescription': 'A change in 20 plasma lipids (fasting triglycerides and lipid fractions) after 20 weeks of treatment with testosterone gel', 'statisticalMethod': 't-test, 2 sided', 'nonInferiorityType': 'OTHER', 'nonInferiorityComment': 'Test for HDL cholesterol'}], 'paramType': 'MEDIAN', 'timeFrame': 'Baseline to week 20', 'unitOfMeasure': 'mg/dL', 'dispersionType': 'Full Range', 'reportingStatus': 'POSTED'}, {'type': 'SECONDARY', 'title': 'Change in HOMA-IR', 'denoms': [{'units': 'Participants', 'counts': [{'value': '20', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'Single Arm', 'description': 'Open label treatment with each participant serving as his own control. Data is compared before and after treatment.\n\nTopical testosterone (Androgel) 10 g/day: Testosterone therapy for 20 weeks'}], 'classes': [{'categories': [{'measurements': [{'value': '-0.75', 'groupId': 'OG000', 'lowerLimit': '-6.94', 'upperLimit': '4.18'}]}]}], 'analyses': [{'pValue': '0.06', 'groupIds': ['OG000'], 'statisticalMethod': 't-test, 2 sided', 'nonInferiorityType': 'OTHER'}], 'paramType': 'MEDIAN', 'timeFrame': 'Baseline to week 20', 'description': 'HOMA-IR is a measure of insulin resistance', 'unitOfMeasure': 'microU/L) x fasting glucose (nmol/L)/22', 'dispersionType': 'Full Range', 'reportingStatus': 'POSTED'}, {'type': 'SECONDARY', 'title': 'Change in Basal FFAs in Plasma', 'denoms': [{'units': 'Participants', 'counts': [{'value': '20', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'Single Arm', 'description': 'Open label treatment with each participant serving as his own control. Data is compared before and after treatment.\n\nTopical testosterone (Androgel) 10 g/day: Testosterone therapy for 20 weeks'}], 'classes': [{'categories': [{'measurements': [{'value': '-0.1', 'groupId': 'OG000', 'lowerLimit': '-0.22', 'upperLimit': '0.21'}]}]}], 'analyses': [{'pValue': '0.97', 'groupIds': ['OG000'], 'statisticalMethod': 't-test, 2 sided', 'nonInferiorityType': 'OTHER'}], 'paramType': 'MEDIAN', 'timeFrame': 'Baseline to week 20', 'description': 'FFA (plasma free fatty acids) are measure of lipid metabolism', 'unitOfMeasure': 'mEq/L', 'dispersionType': 'Full Range', 'reportingStatus': 'POSTED'}, {'type': 'SECONDARY', 'title': 'Change in Plasma Free Fatty Acids During Glucose Clamp', 'denoms': [{'units': 'Participants', 'counts': [{'value': '20', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'Single Arm', 'description': 'Open label treatment with each participant serving as his own control. Data is compared before and after treatment.\n\nTopical testosterone (Androgel) 10 g/day: Testosterone therapy for 20 weeks'}], 'classes': [{'categories': [{'measurements': [{'value': '-0.1', 'groupId': 'OG000', 'lowerLimit': '-0.12', 'upperLimit': '0.17'}]}]}], 'analyses': [{'pValue': '0.83', 'groupIds': ['OG000'], 'statisticalMethod': 't-test, 2 sided', 'nonInferiorityType': 'OTHER'}], 'paramType': 'MEDIAN', 'timeFrame': 'Baseline to 20 weeks', 'unitOfMeasure': 'grams', 'dispersionType': 'Full Range', 'reportingStatus': 'POSTED'}]}, 'participantFlowModule': {'groups': [{'id': 'FG000', 'title': 'Single Arm', 'description': 'Open label treatment with each participant serving as his own control. Data is compared before and after treatment.\n\nTopical testosterone (Androgel) 10 g/day: Testosterone therapy for 20 weeks'}], 'periods': [{'title': 'Overall Study', 'milestones': [{'type': 'STARTED', 'comment': 'All milestones were met 1) target number enrolled and 2) all finished study therapy and measurements', 'achievements': [{'comment': '22 subjects were enrolled since only 20 completed all post treatment measures.', 'groupId': 'FG000', 'numSubjects': '22'}]}, {'type': 'COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '20'}]}, {'type': 'NOT COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '2'}]}], 'dropWithdraws': [{'type': 'Withdrawal by Subject', 'reasons': [{'groupId': 'FG000', 'numSubjects': '2'}]}]}], 'recruitmentDetails': 'Potential subjects were primarily recruited from 2011 to 2013 and were evaluated and studied at the University of Southern California CTSI Clinical Trials Unit. 22 subjects met all eligibility requirements and begun study therapy with testosterone gel. Two did not complete treatment. Thus, 20 completed all evaluations as planned.', 'preAssignmentDetails': 'Consenting subjects were evaluated for eligibility and had to be:\n\nMen 60 years-or-older, with morning testosterone \\<400ng/dL, waist circumference ≥102cm, and evidence of insulin resistance; HgbA1c of 5.7-6.4% \\[20\\] or HOMA-IR ≥4.0. Exclusion criteria included diabetes, PSA ≥4.0μg/L, hct ≥50%, AST ≥2X ULN, concurrent inflammatory condition.'}, 'baselineCharacteristicsModule': {'denoms': [{'units': 'Participants', 'counts': [{'value': '20', 'groupId': 'BG000'}]}], 'groups': [{'id': 'BG000', 'title': 'Single Arm', 'description': 'open label treatment with testosterone gel'}], 'measures': [{'title': 'Age, Continuous', 'classes': [{'categories': [{'measurements': [{'value': '67.5', 'groupId': 'BG000', 'lowerLimit': '62.0', 'upperLimit': '78.0'}]}]}], 'paramType': 'MEDIAN', 'unitOfMeasure': 'years', 'dispersionType': 'FULL_RANGE'}, {'title': 'Sex: Female, Male', 'classes': [{'categories': [{'title': 'Female', 'measurements': [{'value': '0', 'groupId': 'BG000'}]}, {'title': 'Male', 'measurements': [{'value': '20', 'groupId': 'BG000'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Race (NIH/OMB)', 'classes': [{'categories': [{'title': 'American Indian or Alaska Native', 'measurements': [{'value': '0', 'groupId': 'BG000'}]}, {'title': 'Asian', 'measurements': [{'value': '0', 'groupId': 'BG000'}]}, {'title': 'Native Hawaiian or Other Pacific Islander', 'measurements': [{'value': '0', 'groupId': 'BG000'}]}, {'title': 'Black or African American', 'measurements': [{'value': '0', 'groupId': 'BG000'}]}, {'title': 'White', 'measurements': [{'value': '20', 'groupId': 'BG000'}]}, {'title': 'More than one race', 'measurements': [{'value': '0', 'groupId': 'BG000'}]}, {'title': 'Unknown or Not Reported', 'measurements': [{'value': '0', 'groupId': 'BG000'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'AM total testosterone level', 'classes': [{'categories': [{'measurements': [{'value': '10.6', 'groupId': 'BG000', 'lowerLimit': '5.2', 'upperLimit': '13.9'}]}]}], 'paramType': 'MEDIAN', 'unitOfMeasure': 'nmoles/liter', 'dispersionType': 'FULL_RANGE'}, {'title': 'waist circumference', 'classes': [{'categories': [{'measurements': [{'value': '114', 'groupId': 'BG000', 'lowerLimit': '104', 'upperLimit': '122'}]}]}], 'paramType': 'MEDIAN', 'unitOfMeasure': 'centimeters', 'dispersionType': 'FULL_RANGE'}, {'title': 'blood panels', 'classes': [{'title': 'total cholesterol', 'categories': [{'measurements': [{'value': '4.61', 'groupId': 'BG000', 'lowerLimit': '3.00', 'upperLimit': '6.73'}]}]}, {'title': 'LDL cholesterol', 'categories': [{'measurements': [{'value': '3.11', 'groupId': 'BG000', 'lowerLimit': '0.98', 'upperLimit': '5.00'}]}]}, {'title': 'HDL cholesterol', 'categories': [{'measurements': [{'value': '1.06', 'groupId': 'BG000', 'lowerLimit': '0.62', 'upperLimit': '1.76'}]}]}, {'title': 'Fasting triglycerides', 'categories': [{'measurements': [{'value': '1.59', 'groupId': 'BG000', 'lowerLimit': '0.72', 'upperLimit': '4.87'}]}]}], 'paramType': 'MEDIAN', 'unitOfMeasure': 'mmole/liter', 'dispersionType': 'FULL_RANGE'}, {'title': 'Patient history at enrollment', 'classes': [{'title': 'Family history of diabetes', 'categories': [{'measurements': [{'value': '4', 'groupId': 'BG000'}]}]}, {'title': 'Smoking ever', 'categories': [{'measurements': [{'value': '14', 'groupId': 'BG000'}]}]}, {'title': 'Smoking currently', 'categories': [{'measurements': [{'value': '0', 'groupId': 'BG000'}]}]}, {'title': 'On Rx for lipid disorder', 'categories': [{'measurements': [{'value': '12', 'groupId': 'BG000'}]}]}, {'title': 'On Rx for hypertension', 'categories': [{'measurements': [{'value': '10', 'groupId': 'BG000'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Body compotion', 'classes': [{'title': 'Total body mass', 'categories': [{'measurements': [{'value': '104.5', 'groupId': 'BG000', 'lowerLimit': '84.4', 'upperLimit': '133.6'}]}]}, {'title': 'Total fat mass', 'categories': [{'measurements': [{'value': '34.6', 'groupId': 'BG000', 'lowerLimit': '24.3', 'upperLimit': '57.1'}]}]}, {'title': 'Trunk fat mass', 'categories': [{'measurements': [{'value': '19.3', 'groupId': 'BG000', 'lowerLimit': '13.6', 'upperLimit': '30.0'}]}]}, {'title': 'Extremity fat mass', 'categories': [{'measurements': [{'value': '12.9', 'groupId': 'BG000', 'lowerLimit': '9.1', 'upperLimit': '27.6'}]}]}, {'title': 'Total lean body mss', 'categories': [{'measurements': [{'value': '64.3', 'groupId': 'BG000', 'lowerLimit': '47.1', 'upperLimit': '75.0'}]}]}, {'title': 'Extremity lean mass', 'categories': [{'measurements': [{'value': '29.1', 'groupId': 'BG000', 'lowerLimit': '21.2', 'upperLimit': '34.1'}]}]}], 'paramType': 'MEDIAN', 'description': 'kilograms as measured by DEXA', 'unitOfMeasure': 'kilograms', 'dispersionType': 'FULL_RANGE'}, {'title': 'Percentage of body fat', 'classes': [{'categories': [{'measurements': [{'value': '31.5', 'groupId': 'BG000', 'lowerLimit': '23.9', 'upperLimit': '42.7'}]}]}], 'paramType': 'MEDIAN', 'unitOfMeasure': 'percentage', 'dispersionType': 'FULL_RANGE'}, {'title': 'Insulin senstivity', 'classes': [{'title': 'Whole body insulin sensivity', 'categories': [{'measurements': [{'value': '2.93', 'groupId': 'BG000', 'lowerLimit': '1.07', 'upperLimit': '8.51'}]}]}, {'title': 'Hepatic glucose output', 'categories': [{'measurements': [{'value': '2.89', 'groupId': 'BG000', 'lowerLimit': '0.03', 'upperLimit': '7.83'}]}]}, {'title': 'Rate of glucose disposal', 'categories': [{'measurements': [{'value': '2.93', 'groupId': 'BG000', 'lowerLimit': '1.07', 'upperLimit': '8.51'}]}]}], 'paramType': 'MEDIAN', 'unitOfMeasure': 'dL/min per μU/mL;', 'dispersionType': 'FULL_RANGE'}, {'title': 'HOMA-IR', 'classes': [{'categories': [{'measurements': [{'value': '3.55', 'groupId': 'BG000', 'lowerLimit': '0.64', 'upperLimit': '11.4'}]}]}], 'paramType': 'MEDIAN', 'unitOfMeasure': 'microU/L) x fasting glucose (nmol/L)/22.', 'dispersionType': 'FULL_RANGE'}, {'title': 'Basal free fatty acids', 'classes': [{'categories': [{'measurements': [{'value': '0.35', 'groupId': 'BG000', 'lowerLimit': '0.24', 'upperLimit': '0.53'}]}]}], 'paramType': 'MEDIAN', 'unitOfMeasure': 'mEq/L', 'dispersionType': 'FULL_RANGE'}, {'title': 'Change in glucose clamp free fatty acids over 0 to 4 hours', 'classes': [{'categories': [{'measurements': [{'value': '0.30', 'groupId': 'BG000', 'lowerLimit': '0.17', 'upperLimit': '0.41'}]}]}], 'paramType': 'MEDIAN', 'unitOfMeasure': 'grams', 'dispersionType': 'FULL_RANGE'}, {'title': 'Hepatic lipid', 'classes': [{'categories': [{'measurements': [{'value': '0.11', 'groupId': 'BG000', 'lowerLimit': '0.01', 'upperLimit': '1.13'}]}]}], 'paramType': 'MEDIAN', 'description': 'Measurement is adjusted for water content and commonly reported as ratio', 'unitOfMeasure': 'ratio', 'dispersionType': 'FULL_RANGE'}, {'title': 'Intramyocellular lipid (IMCL)', 'classes': [{'categories': [{'measurements': [{'value': '5.8', 'groupId': 'BG000', 'lowerLimit': '0.2', 'upperLimit': '30'}]}]}], 'paramType': 'MEDIAN', 'description': 'IMCL is commonly adjusted for creatine (Cr) content and reported as a raio', 'unitOfMeasure': 'ratio', 'dispersionType': 'FULL_RANGE'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE2'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'NA', 'maskingInfo': {'masking': 'NONE', 'maskingDescription': 'No masking. This was an open label (un-blinded)'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'SINGLE_GROUP'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 22}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2006-08'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2019-08', 'completionDateStruct': {'date': '2014-12', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2019-08-07', 'studyFirstSubmitDate': '2006-08-16', 'resultsFirstSubmitDate': '2017-03-22', 'studyFirstSubmitQcDate': '2006-08-16', 'lastUpdatePostDateStruct': {'date': '2019-08-26', 'type': 'ACTUAL'}, 'resultsFirstSubmitQcDate': '2019-08-07', 'studyFirstPostDateStruct': {'date': '2006-08-17', 'type': 'ESTIMATED'}, 'resultsFirstPostDateStruct': {'date': '2019-08-26', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2013-12', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Change in Total Mass and Regional Adipose Adiposiy', 'timeFrame': 'Baseline to 20 weeks', 'description': 'Change in total body mass, total fat mass, trunk fat, and extremity fat'}, {'measure': 'Change in Hepatic Lipid', 'timeFrame': 'Baseline to week 20', 'description': 'Amount of liver fat is highly predictive of insulin resistance. Hepatic fat is measured by MR spectroscopy and adjusted for H2O and results are reported as ratio of these two.'}, {'measure': 'Intramyocellular Lipid (IMCL)', 'timeFrame': 'Baseline to week 20', 'description': 'IMCL is quantified by MR spectroscopy of the anterior tibialis muscle of the leg. The value is adjusted for creatine and reported as a ratio'}], 'secondaryOutcomes': [{'measure': 'Change in Percentage of Total Body Fat', 'timeFrame': 'Baseline and 20 weeks', 'description': 'Percentage of total body fat is quantified by DEXA scanning'}, {'measure': 'Change in Total and Regional Carbohydrate Metabolism During a 2-hr Hyperinsulinemic Euglycemic Clamp and [6,6-2H2] Glucose Studies (Peripheral Glucose Disposal [Rd],Hepatic Glucose Output [HGO])', 'timeFrame': 'Baseline and 20 weeks', 'description': 'In the final analysis, total and regional carbohydrate metabolism during a 2-hr hyperinsulinemic euglycemic clamp (peripheral glucose disposal \\[Rd\\],hepatic glucose output \\[HGO\\]) were analyzed by mass transfer of glucose during both stages of the clamp relative to insulin levels.'}, {'measure': 'Change in Skeletal Muscle Mass by DEXA', 'timeFrame': 'Baselne to 20 weeks', 'description': 'Skeletal muscle mass was assesed by regional DEXA to quantify appendicular lean tissues which is primarily muscle.'}, {'measure': 'Plasma Lipids', 'timeFrame': 'Baseline to week 20'}, {'measure': 'Change in HOMA-IR', 'timeFrame': 'Baseline to week 20', 'description': 'HOMA-IR is a measure of insulin resistance'}, {'measure': 'Change in Basal FFAs in Plasma', 'timeFrame': 'Baseline to week 20', 'description': 'FFA (plasma free fatty acids) are measure of lipid metabolism'}, {'measure': 'Change in Plasma Free Fatty Acids During Glucose Clamp', 'timeFrame': 'Baseline to 20 weeks'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': True, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['Aging', 'Older men', 'Abdominal obesity', 'Central obesity', 'Insulin resistance', 'Low testosterone'], 'conditions': ['Aging', 'Obesity', 'Insulin Resistance', 'Hypogonadism']}, 'referencesModule': {'references': [{'pmid': '25392748', 'type': 'RESULT', 'citation': 'Sattler F, He J, Chukwuneke J, Kim H, Stewart Y, Colletti P, Yarasheski K, Buchanan T. Testosterone Supplementation Improves Carbohydrate and Lipid Metabolism in Some Older Men with Abdominal Obesity. J Gerontol Geriatr Res. 2014 Jun 7;3(3):1000159. doi: 10.4172/2167-7182.1000159.'}]}, 'descriptionModule': {'briefSummary': 'A. HYPOTHESES: In older men low testosterone levels, abdominal obesity and elevated fasting insulin who are at risk for the cardiovascular complications such as heart attack and stroke.\n\n1. Supplemental testosterone will decrease abdominal adipose tissue and hepatic fat) and appendicular fat and intramyocellular lipid in peripheral muscles (IMCL).\n2. Supplemental testosterone will improve insulin sensitivity by:\n\n 1. Decreasing hepatic glucose output (HGO), a measure of central insulin resistance\n 2. increasing peipheral glucose disposal (Rd), a measure of periperal insuln sensiivity\n 3. . Improving peripheral glucose disposal (Rd) by reducing IMCL\n 4. Increasing appendicular skeletal muscle mass\n\nB. OBJECTIVES:\n\n1. Primary Objective: To determine the effects of supplemental testosterone to achieve testosterone levels in the upper normal physiologic range on central adipose tissue (abdominal and hepatic fat) and peripheral skeletal muscle fat (appendicular fat and IMCL).\n2. Secondary Objectives: To determine the effects of supplemental testosterone to achieve testosterone levels in the upper normal physiologic range:on central insulin sensitivity ( hepatic glucose output (\\[HGO\\]) and peripheral insulin sensitivity (glucose disposal (Rd)\n\nResults of this study will provide greater understanding whether androgen therapy enhances insulin sensitivity by decreasing HGO, improving peripheral Rd and if these desired effects are achieved, whether they are due to reductions in abdominal fat or liver lipid, IMCL or effects of augmenting muscle mass per se.\n\nResults will generate hypotheses to investigate cellular and molecular mechanisms of androgen effects in persons at risk for the Metabolic Syndrome.', 'detailedDescription': 'Study Design: This is an investigator-initiated open label, study to investigate the effects of supplemental testosterone (gel formulation) to increase testosterone levels to the upper normal range in 12 older hypogonadal (testosterone levels less than 300 ng/dL) men with abdominal obesity and elevated fasting insulin levels. Subjects will be assigned to receive 10 g of transdermal testosterone (Androgel) every morning to achieve levels in the upper normal physiologic range (similar to men in the 3rd and 4th decades) for 20 weeks.\n\n* For the primary objective, regional adipose tissue, namely DEXA measures of abdominal and appendicular fat mass and hepatic fat, and IMCL will be quantified by 1H-spectroscopy at baseline (study week 0) and at study week 20 (completion of study therapy).\n* For the secondary objective, insulin sensitivity (peripheral Rd, hepatic glucose output \\[HGO\\]) and hepatic gluconeogenesis will be measured directly during a two stage hyperinsulinemic euglycemic clamp at baseline and study week 20.\n* Indirect markers of lipid (adiponectin, ApoB 100) and carbohydrate metabolism (Fasting blood sugar, HOMA-IR) at study week 10, and study week 20.\n\nAll components of the study will be conducted in the USC NIH-funded (NCRR), General Clinical Research Center.'}, 'eligibilityModule': {'sex': 'MALE', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '90 Years', 'minimumAge': '60 Years', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Entry Criteria:\n* Men \\> 60 years of age\n* Total testosterone \\< 300 ng/dL\n* Waist circumference \\>102 cm\n* Fasting insulin level \\> 18 U/L\n\nExclusion Criteria:\n\n* PSA \\> 4.1, symptoms of obstructive uropathy (AUA score \\> 14), unexplained prostate nodule or gland firmness\n* Hematocrit \\> 50%\n* Malignancy other than cutaneous cancers\n* Sleep apnea requiring CPAP\n* History of myocardial infarction, angina or stroke within the previous 6 months\n* Clinical diagnosis of diabetes or FPG \\> 126 mg/dL\n* Hypothyroidism not controlled to euthyroid levels with medication for at least 3 months\n* LDL-C \\>160 mg/dL\n* Transaminases \\> 1.5X ULN\n* Systemic anticoagulation with warfarin\n* Active progressive resistance training\n* Dieting for weight loss\n* Active inflammatory condition (e.g. rheumatoid arthritis)\n* Use of any anabolic agent (e.g. growth hormone, testosterone precursor, anabolic steroid)or cytokine therapy in the proceeding 12 months'}, 'identificationModule': {'nctId': 'NCT00365794', 'briefTitle': 'Effects of Testosterone Gel on Carbohydrate and Lipid Metabolism In Elderly Obese Men', 'organization': {'class': 'OTHER', 'fullName': 'University of Southern California'}, 'officialTitle': 'Investigator Initiated Study of the Effects of Androgen Therapy on Carbohydrate and Lipid Metabolism In Elderly Men', 'orgStudyIdInfo': {'id': 'GCRC Protocol 1156'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Single arm', 'description': 'Open label treatment without masking with each participant serving as his own control. Measurements are compared before and after treatment.', 'interventionNames': ['Drug: Topical testosterone gel 10 g/day']}], 'interventions': [{'name': 'Topical testosterone gel 10 g/day', 'type': 'DRUG', 'otherNames': ['Androgel'], 'description': 'Testosterone gel therapy for 20 weeks', 'armGroupLabels': ['Single arm']}]}, 'contactsLocationsModule': {'locations': [{'zip': '90033', 'city': 'Los Angeles', 'state': 'California', 'country': 'United States', 'facility': 'LAC-USC Medical Center GCRC', 'geoPoint': {'lat': 34.05223, 'lon': -118.24368}}], 'overallOfficials': [{'name': 'Fred R Sattler, MD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'University of Southern California'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'University of Southern California', 'class': 'OTHER'}, 'collaborators': [{'name': 'Solvay Pharmaceuticals', 'class': 'INDUSTRY'}], 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Professor', 'investigatorFullName': 'Fred Sattler, MD', 'investigatorAffiliation': 'University of Southern California'}}}}