Ignite Creation Date:
2025-12-24 @ 2:47 PM
Ignite Modification Date:
2025-12-26 @ 9:01 AM
Study NCT ID:
NCT01127659
Status:
COMPLETED
Last Update Posted:
2022-11-29
First Post:
2010-05-20
Is NOT Gene Therapy:
True
Has Adverse Events:
True
Brief Title:
Testosterone Replacement in Men With Diabetes and Obesity
Sponsor:
Organization:
Raw JSON
{'hasResults': True, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D007006', 'term': 'Hypogonadism'}, {'id': 'D003920', 'term': 'Diabetes Mellitus'}, {'id': 'D009765', 'term': 'Obesity'}, {'id': 'D007333', 'term': 'Insulin Resistance'}, {'id': 'D007249', 'term': 'Inflammation'}], 'ancestors': [{'id': 'D006058', 'term': 'Gonadal Disorders'}, {'id': 'D004700', 'term': 'Endocrine System Diseases'}, {'id': 'D044882', 'term': 'Glucose Metabolism Disorders'}, {'id': 'D008659', 'term': 'Metabolic Diseases'}, {'id': 'D009750', 'term': 'Nutritional and Metabolic Diseases'}, {'id': 'D050177', 'term': 'Overweight'}, {'id': 'D044343', 'term': 'Overnutrition'}, {'id': 'D009748', 'term': 'Nutrition Disorders'}, {'id': 'D001835', 'term': 'Body Weight'}, {'id': 'D012816', 'term': 'Signs and Symptoms'}, {'id': 'D013568', 'term': 'Pathological Conditions, Signs and Symptoms'}, {'id': 'D006946', 'term': 'Hyperinsulinism'}, {'id': 'D010335', 'term': 'Pathologic Processes'}]}, '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': 'pdandona@kaleidahealth.org', 'phone': '716) 961-9900', 'title': 'Paresh Dandona', 'organization': 'University of Buffalo'}, 'certainAgreement': {'piSponsorEmployee': True}}, 'adverseEventsModule': {'eventGroups': [{'id': 'EG000', 'title': 'Diabetes With HH: Testosterone', 'description': 'active drug diabetes hypogonadal arm\n\ntestosterone: intramuscular every 2 weeks', 'otherNumAtRisk': 22, 'otherNumAffected': 0, 'seriousNumAtRisk': 22, 'seriousNumAffected': 0}, {'id': 'EG001', 'title': 'Diabetes With HH: Placebo', 'description': 'placebo diabetes hypogonadal arm\n\nplacebo: saline intramuscular every 2 weeks', 'otherNumAtRisk': 22, 'otherNumAffected': 0, 'seriousNumAtRisk': 22, 'seriousNumAffected': 0}, {'id': 'EG002', 'title': 'Obese With HH: Testosterone', 'description': 'active drug obese hypogonadal arm\n\ntestosterone: intramuscular every 2 weeks', 'otherNumAtRisk': 12, 'otherNumAffected': 0, 'seriousNumAtRisk': 12, 'seriousNumAffected': 0}, {'id': 'EG003', 'title': 'Obese With HH: Placebo', 'description': 'placebo obese hypogonadal arm\n\nplacebo: saline intramuscular every 2 weeks', 'otherNumAtRisk': 10, 'otherNumAffected': 0, 'seriousNumAtRisk': 10, 'seriousNumAffected': 0}, {'id': 'EG004', 'title': 'Eugonadal Diabetes', 'description': 'diabetic men with normal testosterone', 'otherNumAtRisk': 50, 'otherNumAffected': 0, 'seriousNumAtRisk': 50, 'seriousNumAffected': 0}, {'id': 'EG005', 'title': 'Eugonadal Obese', 'description': 'obese non-diabetic men with normal testosterone', 'otherNumAtRisk': 21, 'otherNumAffected': 0, 'seriousNumAtRisk': 21, 'seriousNumAffected': 0}], 'frequencyThreshold': '5'}, 'outcomeMeasuresModule': {'outcomeMeasures': [{'type': 'PRIMARY', 'title': 'Insulin Sensitivity', 'denoms': [{'units': 'Participants', 'counts': [{'value': '20', 'groupId': 'OG000'}, {'value': '14', 'groupId': 'OG001'}, {'value': '10', 'groupId': 'OG002'}, {'value': '6', 'groupId': 'OG003'}, {'value': '50', 'groupId': 'OG004'}, {'value': '21', 'groupId': 'OG005'}]}], 'groups': [{'id': 'OG000', 'title': 'Diabetes With HH: Testosterone', 'description': 'active drug diabetes hypogonadal arm\n\ntestosterone: intramuscular every 2 weeks\n\nGlucose infusion rate: 6.5+/-4.0 mg/kg fat-free mass/min'}, {'id': 'OG001', 'title': 'Diabetes With HH: Placebo', 'description': 'placebo diabetes hypogonadal arm\n\nplacebo: saline intramuscular every 2 weeks'}, {'id': 'OG002', 'title': 'Obese With HH: Testosterone', 'description': 'active drug obese hypogonadal arm\n\ntestosterone: intramuscular every 2 weeks'}, {'id': 'OG003', 'title': 'Obese With HH: Placebo', 'description': 'placebo obese hypogonadal arm\n\nplacebo: saline intramuscular every 2 weeks'}, {'id': 'OG004', 'title': 'Eugonadal Diabetes', 'description': 'diabetic men with normal testosterone. these participants did not contribute to the assessment at 6 months because they did not undergo the intervention'}, {'id': 'OG005', 'title': 'Eugonadal Obese', 'description': 'obese non-diabetic men with normal testosterone. these participants did not contribute to the assessment at 6 months because they did not undergo the intervention'}], 'classes': [{'title': 'baseline', 'denoms': [{'units': 'Participants', 'counts': [{'value': '20', 'groupId': 'OG000'}, {'value': '14', 'groupId': 'OG001'}, {'value': '10', 'groupId': 'OG002'}, {'value': '6', 'groupId': 'OG003'}, {'value': '50', 'groupId': 'OG004'}, {'value': '21', 'groupId': 'OG005'}]}], 'categories': [{'measurements': [{'value': '6.66', 'spread': '4.36', 'groupId': 'OG000'}, {'value': '5.12', 'spread': '2.79', 'groupId': 'OG001'}, {'value': '11.37', 'spread': '8.83', 'groupId': 'OG002'}, {'value': '12.93', 'spread': '5.16', 'groupId': 'OG003'}, {'value': '10.29', 'spread': '5.55', 'groupId': 'OG004'}, {'value': '12.30', 'spread': '5.96', 'groupId': 'OG005'}]}]}, {'title': '6 months', 'denoms': [{'units': 'Participants', 'counts': [{'value': '20', 'groupId': 'OG000'}, {'value': '14', 'groupId': 'OG001'}, {'value': '10', 'groupId': 'OG002'}, {'value': '6', 'groupId': 'OG003'}, {'value': '0', 'groupId': 'OG004'}, {'value': '0', 'groupId': 'OG005'}]}], 'categories': [{'measurements': [{'value': '8.73', 'spread': '4.27', 'groupId': 'OG000'}, {'value': '5.06', 'spread': '3.62', 'groupId': 'OG001'}, {'value': '12.96', 'spread': '7.11', 'groupId': 'OG002'}, {'value': '14.57', 'spread': '1.71', 'groupId': 'OG003'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'baseline to 6 months', 'description': 'measured by HE clamps (baseline and 6 mths)', 'unitOfMeasure': 'mg/kg fat free mass/min', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'Glucose infusion rate in HE clamps was measured'}, {'type': 'SECONDARY', 'title': 'Body Composition', 'denoms': [{'units': 'Participants', 'counts': [{'value': '20', 'groupId': 'OG000'}, {'value': '14', 'groupId': 'OG001'}, {'value': '10', 'groupId': 'OG002'}, {'value': '6', 'groupId': 'OG003'}, {'value': '50', 'groupId': 'OG004'}, {'value': '21', 'groupId': 'OG005'}]}], 'groups': [{'id': 'OG000', 'title': 'Diabetes With HH: Testosterone', 'description': 'active drug diabetes arm\n\ntestosterone: intramuscular every 2 weeks'}, {'id': 'OG001', 'title': 'Diabetes With HH: Placebo', 'description': 'placebo diabetes arm\n\nplacebo: saline intramuscular every 2 weeks'}, {'id': 'OG002', 'title': 'Obese Testosterone', 'description': 'active drug obese arm\n\ntestosterone: intramuscular every 2 weeks'}, {'id': 'OG003', 'title': 'Obese Placebo', 'description': 'placebo obese arm\n\nplacebo: saline intramuscular every 2 weeks'}, {'id': 'OG004', 'title': 'Eugonadal Diabetes', 'description': 'no intervention. these participants did not contribute to the assessment at 6 months because they did not undergo the intervention.'}, {'id': 'OG005', 'title': 'Eugonadal Obese', 'description': 'no intervention. these participants did not contribute to the assessment at 6 months because they did not undergo the intervention.'}], 'classes': [{'title': 'Baseline', 'denoms': [{'units': 'Participants', 'counts': [{'value': '20', 'groupId': 'OG000'}, {'value': '14', 'groupId': 'OG001'}, {'value': '10', 'groupId': 'OG002'}, {'value': '6', 'groupId': 'OG003'}, {'value': '50', 'groupId': 'OG004'}, {'value': '21', 'groupId': 'OG005'}]}], 'categories': [{'measurements': [{'value': '44.5', 'spread': '13.7', 'groupId': 'OG000'}, {'value': '44.5', 'spread': '15.0', 'groupId': 'OG001'}, {'value': '50.2', 'spread': '9.5', 'groupId': 'OG002'}, {'value': '48.8', 'spread': '10.4', 'groupId': 'OG003'}, {'value': '34.0', 'spread': '12.0', 'groupId': 'OG004'}, {'value': '40.2', 'spread': '12.4', 'groupId': 'OG005'}]}]}, {'title': '24 WEEKS', 'denoms': [{'units': 'Participants', 'counts': [{'value': '20', 'groupId': 'OG000'}, {'value': '14', 'groupId': 'OG001'}, {'value': '10', 'groupId': 'OG002'}, {'value': '6', 'groupId': 'OG003'}, {'value': '0', 'groupId': 'OG004'}, {'value': '0', 'groupId': 'OG005'}]}], 'categories': [{'measurements': [{'value': '42.1', 'spread': '12.5', 'groupId': 'OG000'}, {'value': '45.4', 'spread': '14.4', 'groupId': 'OG001'}, {'value': '46.4', 'spread': '11.7', 'groupId': 'OG002'}, {'value': '48.4', 'spread': '11.2', 'groupId': 'OG003'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'baseline to 6 months', 'description': 'Body composition using Total body fat mass (kg)', 'unitOfMeasure': 'kg', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'Body composition using Total body fat mass (kg)'}]}, 'participantFlowModule': {'groups': [{'id': 'FG000', 'title': 'Diabetes With HH: Testosterone', 'description': 'active drug diabetes arm\n\ntestosterone: intramuscular every 2 weeks'}, {'id': 'FG001', 'title': 'Diabetes With HH: Placebo', 'description': 'placebo diabetes arm\n\nplacebo: saline intramuscular every 2 weeks'}, {'id': 'FG002', 'title': 'Obese Testosterone', 'description': 'active drug obese arm\n\ntestosterone: intramuscular every 2 weeks'}, {'id': 'FG003', 'title': 'Obese Placebo', 'description': 'placebo obese arm\n\nplacebo: saline intramuscular every 2 weeks'}, {'id': 'FG004', 'title': 'Eugonadal Diabetes', 'description': 'no intervention. Only baseline data collected'}, {'id': 'FG005', 'title': 'Eugonadal Obese', 'description': 'no intervention. Only baseline data collected'}], 'periods': [{'title': 'Overall Study', 'milestones': [{'type': 'STARTED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '22'}, {'groupId': 'FG001', 'numSubjects': '22'}, {'groupId': 'FG002', 'numSubjects': '12'}, {'groupId': 'FG003', 'numSubjects': '10'}, {'groupId': 'FG004', 'numSubjects': '50'}, {'groupId': 'FG005', 'numSubjects': '21'}]}, {'type': 'COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '20'}, {'groupId': 'FG001', 'numSubjects': '14'}, {'groupId': 'FG002', 'numSubjects': '10'}, {'groupId': 'FG003', 'numSubjects': '6'}, {'groupId': 'FG004', 'numSubjects': '50'}, {'groupId': 'FG005', 'numSubjects': '21'}]}, {'type': 'NOT COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '2'}, {'groupId': 'FG001', 'numSubjects': '8'}, {'groupId': 'FG002', 'numSubjects': '2'}, {'groupId': 'FG003', 'numSubjects': '4'}, {'groupId': 'FG004', 'numSubjects': '0'}, {'groupId': 'FG005', 'numSubjects': '0'}]}]}]}, 'baselineCharacteristicsModule': {'denoms': [{'units': 'Participants', 'counts': [{'value': '22', 'groupId': 'BG000'}, {'value': '12', 'groupId': 'BG001'}, {'value': '10', 'groupId': 'BG002'}, {'value': '22', 'groupId': 'BG003'}, {'value': '50', 'groupId': 'BG004'}, {'value': '21', 'groupId': 'BG005'}, {'value': '137', 'groupId': 'BG006'}]}], 'groups': [{'id': 'BG000', 'title': 'Diabetes With HH: Testosterone', 'description': 'active drug diabetes hypogonadal arm\n\ntestosterone: intramuscular every 2 weeks'}, {'id': 'BG001', 'title': 'Obese With HH: Testosterone', 'description': 'active drug obese hypogonadal arm\n\ntestosterone: intramuscular every 2 weeks'}, {'id': 'BG002', 'title': 'Obese With HH: Placebo', 'description': 'placebo obese hypogonadal arm\n\nplacebo: saline intramuscular every 2 weeks'}, {'id': 'BG003', 'title': 'Diabetes With HH: Placebo', 'description': 'placebo diabetes hypogonadal arm\n\nplacebo: saline intramuscular every 2 weeks'}, {'id': 'BG004', 'title': 'Eugonadal Diabetes', 'description': 'diabetic men with normal testosterone'}, {'id': 'BG005', 'title': 'Eugonadal Obese', 'description': 'obese non-diabetic men with normal testosterone'}, {'id': 'BG006', 'title': 'Total', 'description': 'Total of all reporting groups'}], 'measures': [{'title': 'Age, Categorical', 'classes': [{'categories': [{'title': '<=18 years', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}, {'value': '0', 'groupId': 'BG003'}, {'value': '0', 'groupId': 'BG004'}, {'value': '0', 'groupId': 'BG005'}, {'value': '0', 'groupId': 'BG006'}]}, {'title': 'Between 18 and 65 years', 'measurements': [{'value': '22', 'groupId': 'BG000'}, {'value': '12', 'groupId': 'BG001'}, {'value': '10', 'groupId': 'BG002'}, {'value': '22', 'groupId': 'BG003'}, {'value': '50', 'groupId': 'BG004'}, {'value': '21', 'groupId': 'BG005'}, {'value': '137', 'groupId': 'BG006'}]}, {'title': '>=65 years', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}, {'value': '0', 'groupId': 'BG003'}, {'value': '0', 'groupId': 'BG004'}, {'value': '0', 'groupId': 'BG005'}, {'value': '0', 'groupId': 'BG006'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Age, Continuous', 'classes': [{'categories': [{'measurements': [{'value': '54', 'spread': '7', 'groupId': 'BG000'}, {'value': '46', 'spread': '9', 'groupId': 'BG001'}, {'value': '53', 'spread': '7', 'groupId': 'BG002'}, {'value': '54', 'spread': '9', 'groupId': 'BG003'}, {'value': '52', 'spread': '9', 'groupId': 'BG004'}, {'value': '50', 'spread': '8', 'groupId': 'BG005'}, {'value': '52', 'spread': '8', 'groupId': 'BG006'}]}]}], 'paramType': 'MEAN', 'unitOfMeasure': 'years', 'dispersionType': 'STANDARD_DEVIATION'}, {'title': 'Sex: Female, Male', 'classes': [{'categories': [{'title': 'Female', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}, {'value': '0', 'groupId': 'BG003'}, {'value': '0', 'groupId': 'BG004'}, {'value': '0', 'groupId': 'BG005'}, {'value': '0', 'groupId': 'BG006'}]}, {'title': 'Male', 'measurements': [{'value': '22', 'groupId': 'BG000'}, {'value': '12', 'groupId': 'BG001'}, {'value': '10', 'groupId': 'BG002'}, {'value': '22', 'groupId': 'BG003'}, {'value': '50', 'groupId': 'BG004'}, {'value': '21', 'groupId': 'BG005'}, {'value': '137', 'groupId': 'BG006'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Region of Enrollment', 'classes': [{'title': 'United States', 'categories': [{'measurements': [{'value': '22', 'groupId': 'BG000'}, {'value': '12', 'groupId': 'BG001'}, {'value': '10', 'groupId': 'BG002'}, {'value': '22', 'groupId': 'BG003'}, {'value': '50', 'groupId': 'BG004'}, {'value': '21', 'groupId': 'BG005'}, {'value': '137', 'groupId': 'BG006'}]}]}], 'paramType': 'NUMBER', 'unitOfMeasure': 'participants'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE4'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'DOUBLE', 'whoMasked': ['PARTICIPANT', 'INVESTIGATOR']}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 137}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2010-05'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2022-10', 'completionDateStruct': {'date': '2015-11', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2022-10-31', 'studyFirstSubmitDate': '2010-05-20', 'resultsFirstSubmitDate': '2017-01-13', 'studyFirstSubmitQcDate': '2010-05-20', 'lastUpdatePostDateStruct': {'date': '2022-11-29', 'type': 'ACTUAL'}, 'resultsFirstSubmitQcDate': '2017-01-13', 'studyFirstPostDateStruct': {'date': '2010-05-21', 'type': 'ESTIMATED'}, 'resultsFirstPostDateStruct': {'date': '2017-03-07', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2015-03', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Insulin Sensitivity', 'timeFrame': 'baseline to 6 months', 'description': 'measured by HE clamps (baseline and 6 mths)'}], 'secondaryOutcomes': [{'measure': 'Body Composition', 'timeFrame': 'baseline to 6 months', 'description': 'Body composition using Total body fat mass (kg)'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'keywords': ['diabetes', 'hypogonadism', 'obesity', 'testosterone', 'insulin sensitivity', 'inflammation'], 'conditions': ['Hypogonadism']}, 'referencesModule': {'references': [{'pmid': '31858126', 'type': 'DERIVED', 'citation': 'Ghanim H, Dhindsa S, Batra M, Green K, Abuaysheh S, Kuhadiya ND, Makdissi A, Chaudhuri A, Sandhu S, Dandona P. Testosterone Increases the Expression and Phosphorylation of AMP Kinase alpha in Men With Hypogonadism and Type 2 Diabetes. J Clin Endocrinol Metab. 2020 Apr 1;105(4):1169-75. doi: 10.1210/clinem/dgz288.'}, {'pmid': '30629183', 'type': 'DERIVED', 'citation': 'Ghanim H, Dhindsa S, Batra M, Green K, Abuaysheh S, Kuhadiya ND, Makdissi A, Chaudhuri A, Dandona P. Effect of Testosterone on FGF2, MRF4, and Myostatin in Hypogonadotropic Hypogonadism: Relevance to Muscle Growth. J Clin Endocrinol Metab. 2019 Jun 1;104(6):2094-2102. doi: 10.1210/jc.2018-01832.'}, {'pmid': '26622051', 'type': 'DERIVED', 'citation': 'Dhindsa S, Ghanim H, Batra M, Kuhadiya ND, Abuaysheh S, Sandhu S, Green K, Makdissi A, Hejna J, Chaudhuri A, Punyanitya M, Dandona P. Insulin Resistance and Inflammation in Hypogonadotropic Hypogonadism and Their Reduction After Testosterone Replacement in Men With Type 2 Diabetes. Diabetes Care. 2016 Jan;39(1):82-91. doi: 10.2337/dc15-1518. Epub 2015 Nov 29.'}]}, 'descriptionModule': {'briefSummary': 'The purpose of this study is to examine the effect of having testosterone deficiency in men with diabetes and with obesity. The study will also evaluate the effect of testosterone therapy. This will be done by comparing the changes in several body response indicators following treatment with testosterone in diabetic or obese-non diabetic men with low testosterone levels and comparing them to diabetic or obese-non diabetic men with low testosterone who are not treated with testosterone.', 'detailedDescription': 'Hypogonadotropic hypogonadism (HH) occurs in approximately one-third of obese and type 2 diabetic men. Considering that there are 24 million diabetic and 100 million obese people, of which half are males, obesity and type 2 diabetes potentially constitute the major cause of hypogonadism in the population. We hypothesize that 1) HH in obese and type 2 diabetic men is associated with decreased insulin sensitivity, increased fat tissue mass, decreased lean body mass, increased inflammatory and oxidative stress, impaired sexual function and depressed mood as compared to diabetic and obese men with normal testosterone concentrations; and that 2) testosterone replacement for 24 weeks in men with HH leads to an improvement in these parameters. Our proposed study would be the first prospective, randomized trial to comprehensively evaluate the effect of HH on insulin sensitivity, body composition, inflammatory and oxidative indices in obese and type 2 diabetic subjects and the effect of six months of T replacement on these parameters. The study will have 2 arms (obese and type 2 diabetic arm) with 120 subjects in Diabetes arm and 80 subjects in obese arm. Half of men in each arm will have HH and half men will have normal testosterone concentrations(eugonadal men). Insulin sensitivity will be assessed by hyperinsulinemic-euglycemic clamps. Subcutaneous fat mass and lean body mass will be measured by DEXA and intra-abdominal (visceral) fat mass by MRI. All subjects will undergo hyperinsulinemic-euglycemic clamp, MRI, DEXA and give blood and urine samples (for measurement of inflammatory and oxidative stress) at baseline. Men with HH will then be randomized to receive testosterone or placebo gel for a total of 24 weeks. These men will undergo hyperinsulinemic-euglycemic clamps and give blood and urine samples for inflammation and oxidative stress at 4 weeks and 24 weeks. MRI and DEXA examinations will be carried out at 24 weeks again in men with HH. The primary endpoint of the study is to define a difference in whole body glucose uptake during hyperinsulinemic-euglycemic clamps between hypogonadal and eugonadal diabetes patients at baseline and an increase in glucose uptake in HH subjects after treatment with testosterone for 24 weeks. 30 subjects per group(testosterone and placebo gel each) will provide adequate power (0.8) to detect a significant difference of 10% in whole body glucose uptake. Therefore there will be 60 men with HH in each arm in diabetes group. For baseline comparisons, 60 men with normal testosterone concentrations will also be needed in each arm. We will recruit 40 obese patients in each arm. Thus there will be 120 diabetic men and 80 obese men in the study.'}, 'eligibilityModule': {'sex': 'MALE', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '65 Years', 'minimumAge': '30 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* T2D arm: Males with age 30-65 years\n* Obese non-diabetic arm: Obese non-diabetic males with age 30-65 years\n\nExclusion Criteria:\n\n1)Coronary event or procedure(myocardial infarction, unstable angina, coronary artery bypass, surgery or coronary angioplasty) in the previous twelve weeks; 2) PSA \\> 4ng/ml; 3)Hemoglobin A1c \\> 8%; 4)h/o prostate carcinoma; 5)Hepatic disease (transaminase \\> 3 times normal) or cirrhosis; 6)Renal impairment (defined as GFR\\<30); 7)HIV or Hepatitis C positive status; 9)Participation in any other concurrent clinical trial; 10)Any other life-threatening, non-cardiac disease; 11)Use of over the counter health supplements which contain androgens; 12)Use of an investigational agent or therapeutic regimen within 30 days of study; 13)prostate nodule or severe enlargement on digital rectal examination; 14)Use of testosterone currently or in the past 4 months; 15)Hematocrit \\> 50%; 16)History of untreated severe obstructive sleep apnea(defined as apnea-hypopnea index ≥30); 17)symptoms suggestive of severe BPH; 18)Congestive heart failure, class III or IV; 20)Known to have anemia secondary to iron, B12 or folic acid deficiency; 21)bone marrow disorder such as myelodysplasia or aplastic anemia; 22) currently suffering from symptomatic depression, with or without treatment; 23) history of severe depression in the past which needed hospitalization; 24)currently suffering from foot ulcer, significant periodontal disease or any other chronic infectious condition; 25)planning to have children. 26) Subjects on testosterone or with testosterone replacement in the past 4 months will be excluded.'}, 'identificationModule': {'nctId': 'NCT01127659', 'briefTitle': 'Testosterone Replacement in Men With Diabetes and Obesity', 'organization': {'class': 'OTHER', 'fullName': 'University at Buffalo'}, 'officialTitle': 'Effect of Hypogonadotrophic Hypogonadism and Treatment With Testosterone on Insulin Sensitivity, Inflammation, Body Composition and Sexual Function in Obese and Type 2 Diabetic Men', 'orgStudyIdInfo': {'id': 'NIH testosterone grant'}, 'secondaryIdInfos': [{'id': 'R01DK075877', 'link': 'https://reporter.nih.gov/quickSearch/R01DK075877', 'type': 'NIH'}]}, 'armsInterventionsModule': {'armGroups': [{'type': 'ACTIVE_COMPARATOR', 'label': 'diabetes with HH-active', 'description': 'Subjects with diabetes and hypogonadotropic hypogonadism. They will be randomized to testosterone intervention.', 'interventionNames': ['Drug: testosterone']}, {'type': 'NO_INTERVENTION', 'label': 'diabetes with normal testosterone', 'description': 'Eugonadal subjects with diabetes. They will not be treated'}, {'type': 'ACTIVE_COMPARATOR', 'label': 'obese with HH-active', 'description': 'Obese non-diabetic men hypogonadotropic hypogonadism. They will be randomized to testosterone intervention.', 'interventionNames': ['Drug: testosterone']}, {'type': 'NO_INTERVENTION', 'label': 'obese with normal testosterone', 'description': 'Eugonadal non-diabetic obese subjects. They will not be treated'}, {'type': 'PLACEBO_COMPARATOR', 'label': 'Diabetes with HH-placebo', 'description': 'Subjects with diabetes and hypogonadotropic hypogonadism. They will be randomized to placebo.', 'interventionNames': ['Drug: placebo']}, {'type': 'PLACEBO_COMPARATOR', 'label': 'Obese with HH-placebo', 'description': 'Obese non-diabetic men hypogonadotropic hypogonadism. They will be randomized to placebo.', 'interventionNames': ['Drug: placebo']}], 'interventions': [{'name': 'testosterone', 'type': 'DRUG', 'description': 'intramuscular every 2 weeks', 'armGroupLabels': ['diabetes with HH-active', 'obese with HH-active']}, {'name': 'placebo', 'type': 'DRUG', 'description': 'saline intramuscular every 2 weeks', 'armGroupLabels': ['Diabetes with HH-placebo', 'Obese with HH-placebo']}]}, 'contactsLocationsModule': {'locations': [{'zip': '14221', 'city': 'Williamsville', 'state': 'New York', 'country': 'United States', 'facility': '115 Flint Road', 'geoPoint': {'lat': 42.96395, 'lon': -78.73781}}], 'overallOfficials': [{'name': 'Paresh Dandona, MBBS', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'SUNY at Buffalo'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'University at Buffalo', 'class': 'OTHER'}, 'collaborators': [{'name': 'National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)', 'class': 'NIH'}], 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'MD', 'investigatorFullName': 'Paresh Dandona', 'investigatorAffiliation': 'University at Buffalo'}}}}