Ignite Creation Date:
2025-12-25 @ 5:03 AM
Ignite Modification Date:
2025-12-26 @ 4:05 AM
Study NCT ID:
NCT01155518
Status:
TERMINATED
Last Update Posted:
2019-10-04
First Post:
2010-06-30
Is NOT Gene Therapy:
False
Has Adverse Events:
True
Brief Title:
Hypogonadism in Young Men With Type 2 Diabetes
Sponsor:
Organization:
Raw JSON
{'hasResults': True, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D007006', 'term': 'Hypogonadism'}, {'id': 'D003924', 'term': 'Diabetes Mellitus, Type 2'}, {'id': 'D003920', 'term': 'Diabetes Mellitus'}, {'id': 'D007333', 'term': 'Insulin Resistance'}], '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': 'D006946', 'term': 'Hyperinsulinism'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D013739', 'term': 'Testosterone'}, {'id': 'D002996', 'term': 'Clomiphene'}], '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'}, {'id': 'D013267', 'term': 'Stilbenes'}, {'id': 'D001597', 'term': 'Benzylidene Compounds'}, {'id': 'D001555', 'term': 'Benzene Derivatives'}, {'id': 'D006841', 'term': 'Hydrocarbons, Aromatic'}, {'id': 'D006844', 'term': 'Hydrocarbons, Cyclic'}, {'id': 'D006838', 'term': 'Hydrocarbons'}, {'id': 'D009930', 'term': 'Organic Chemicals'}]}}, 'resultsSection': {'moreInfoModule': {'pointOfContact': {'email': 'sandhindsa@yahoo.com', 'title': 'sandeep dhindsa', 'organization': 'suny buffalo'}, 'certainAgreement': {'piSponsorEmployee': True}}, 'adverseEventsModule': {'eventGroups': [{'id': 'EG000', 'title': 'Testosterone', 'description': 'intramuscular injections every 2 weeks\n\ntestosterone: intramuscular every 2 weeks', 'otherNumAtRisk': 1, 'deathsNumAtRisk': 1, 'otherNumAffected': 0, 'seriousNumAtRisk': 1, 'deathsNumAffected': 0, 'seriousNumAffected': 0}, {'id': 'EG001', 'title': 'Clomiphene', 'description': 'oral drug thrice a week\n\nclomiphene: thrice a week', 'otherNumAtRisk': 1, 'deathsNumAtRisk': 1, 'otherNumAffected': 0, 'seriousNumAtRisk': 1, 'deathsNumAffected': 0, 'seriousNumAffected': 0}, {'id': 'EG002', 'title': 'Placebo for Testosterone', 'description': 'placebo for testosterone arm\n\nplacebo: intramuscular saline injections every 2 weeks', 'otherNumAtRisk': 0, 'deathsNumAtRisk': 0, 'otherNumAffected': 0, 'seriousNumAtRisk': 0, 'deathsNumAffected': 0, 'seriousNumAffected': 0}, {'id': 'EG003', 'title': 'Placebo for Clomiphene', 'description': 'oral placebo for clomiphene arm\n\nplacebo: oral', 'otherNumAtRisk': 0, 'deathsNumAtRisk': 0, 'otherNumAffected': 0, 'seriousNumAtRisk': 0, 'deathsNumAffected': 0, 'seriousNumAffected': 0}, {'id': 'EG004', 'title': 'Eugonadal Obese', 'description': 'obese men with normal testosterone levels', 'otherNumAtRisk': 1, 'deathsNumAtRisk': 1, 'otherNumAffected': 0, 'seriousNumAtRisk': 1, 'deathsNumAffected': 0, 'seriousNumAffected': 0}, {'id': 'EG005', 'title': 'Control', 'description': 'healthy lean men with normal testosterone levels', 'otherNumAtRisk': 2, 'deathsNumAtRisk': 2, 'otherNumAffected': 0, 'seriousNumAtRisk': 2, 'deathsNumAffected': 0, 'seriousNumAffected': 0}], 'frequencyThreshold': '0'}, 'outcomeMeasuresModule': {'outcomeMeasures': [{'type': 'PRIMARY', 'title': 'Insulin Resistance', 'denoms': [{'units': 'Participants', 'counts': [{'value': '0', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}, {'value': '0', 'groupId': 'OG002'}, {'value': '0', 'groupId': 'OG003'}, {'value': '0', 'groupId': 'OG004'}, {'value': '0', 'groupId': 'OG005'}]}], 'groups': [{'id': 'OG000', 'title': 'Testosterone', 'description': 'intramuscular injections every 2 weeks\n\ntestosterone: intramuscular every 2 weeks'}, {'id': 'OG001', 'title': 'Clomiphene', 'description': 'oral drug thrice a week\n\nclomiphene: thrice a week'}, {'id': 'OG002', 'title': 'Placebo for Testosterone', 'description': 'placebo for testosterone arm\n\nplacebo: intramuscular saline injections every 2 weeks'}, {'id': 'OG003', 'title': 'Placebo for Clomiphene', 'description': 'oral placebo for clomiphene arm\n\nplacebo: oral'}, {'id': 'OG004', 'title': 'Eugonadal Obese', 'description': 'normal testosterone men'}, {'id': 'OG005', 'title': 'Normal Lean', 'description': 'control'}], 'timeFrame': '6 months', 'description': 'To compare the insulin sensitivity as measured by whole body glucose uptake during hyperinsulinemic euglycemic (HE) clamp in young T2D men with and without HH.', 'reportingStatus': 'POSTED', 'populationDescription': 'study terminated'}]}, 'participantFlowModule': {'groups': [{'id': 'FG000', 'title': 'Testosterone', 'description': 'intramuscular injections every 2 weeks\n\ntestosterone: intramuscular every 2 weeks'}, {'id': 'FG001', 'title': 'Clomiphene', 'description': 'oral drug thrice a week\n\nclomiphene: thrice a week'}, {'id': 'FG002', 'title': 'Placebo for Testosterone', 'description': 'placebo for testosterone arm\n\nplacebo: intramuscular saline injections every 2 weeks'}, {'id': 'FG003', 'title': 'Placebo for Clomiphene', 'description': 'oral placebo for clomiphene arm\n\nplacebo: oral'}, {'id': 'FG004', 'title': 'Eugonadal Obese', 'description': 'men with obesity and normal testosterone levels'}, {'id': 'FG005', 'title': 'Control', 'description': 'lean healthy men with normal testosterone levels'}], 'periods': [{'title': 'Overall Study', 'milestones': [{'type': 'STARTED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '1'}, {'groupId': 'FG001', 'numSubjects': '1'}, {'groupId': 'FG002', 'numSubjects': '0'}, {'groupId': 'FG003', 'numSubjects': '0'}, {'groupId': 'FG004', 'numSubjects': '1'}, {'groupId': 'FG005', 'numSubjects': '2'}]}, {'type': 'COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '1'}, {'comment': 'never started the study', 'groupId': 'FG001', 'numSubjects': '0'}, {'groupId': 'FG002', 'numSubjects': '0'}, {'groupId': 'FG003', 'numSubjects': '0'}, {'groupId': 'FG004', 'numSubjects': '1'}, {'groupId': 'FG005', 'numSubjects': '2'}]}, {'type': 'NOT COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '0'}, {'groupId': 'FG001', 'numSubjects': '1'}, {'groupId': 'FG002', 'numSubjects': '0'}, {'groupId': 'FG003', 'numSubjects': '0'}, {'groupId': 'FG004', 'numSubjects': '0'}, {'groupId': 'FG005', 'numSubjects': '0'}]}]}]}, 'baselineCharacteristicsModule': {'denoms': [{'units': 'Participants', 'counts': [{'value': '1', 'groupId': 'BG000'}, {'value': '1', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}, {'value': '0', 'groupId': 'BG003'}, {'value': '1', 'groupId': 'BG004'}, {'value': '2', 'groupId': 'BG005'}, {'value': '5', 'groupId': 'BG006'}]}], 'groups': [{'id': 'BG000', 'title': 'Testosterone', 'description': 'intramuscular injections every 2 weeks\n\ntestosterone: intramuscular every 2 weeks'}, {'id': 'BG001', 'title': 'Clomiphene', 'description': 'oral drug thrice a week\n\nclomiphene: thrice a week'}, {'id': 'BG002', 'title': 'Placebo for Testosterone', 'description': 'placebo for testosterone arm\n\nplacebo: intramuscular saline injections every 2 weeks'}, {'id': 'BG003', 'title': 'Placebo for Clomiphene', 'description': 'oral placebo for clomiphene arm\n\nplacebo: oral'}, {'id': 'BG004', 'title': 'Eugonadal Obese', 'description': 'obese men with normal testosterone level'}, {'id': 'BG005', 'title': 'Lean', 'description': 'healthy lean men (control)'}, {'id': 'BG006', 'title': 'Total', 'description': 'Total of all reporting groups'}], 'measures': [{'title': 'Age, Continuous', 'classes': [{'categories': [{'measurements': [{'value': '34', 'spread': '0', 'groupId': 'BG000'}, {'value': '30', 'spread': '0', 'groupId': 'BG001'}, {'value': '36', 'spread': '0', 'groupId': 'BG004'}, {'value': '21', 'spread': '1', 'groupId': 'BG005'}, {'value': '30', 'spread': '7', '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': '1', 'groupId': 'BG000'}, {'value': '1', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}, {'value': '0', 'groupId': 'BG003'}, {'value': '1', 'groupId': 'BG004'}, {'value': '2', 'groupId': 'BG005'}, {'value': '5', 'groupId': 'BG006'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Region of Enrollment', 'classes': [{'title': 'United States', 'categories': [{'measurements': [{'value': '1', 'groupId': 'BG000'}, {'value': '1', 'groupId': 'BG001'}, {'value': '1', 'groupId': 'BG004'}, {'value': '2', 'groupId': 'BG005'}, {'value': '5', 'groupId': 'BG006'}]}]}], 'paramType': 'NUMBER', 'unitOfMeasure': 'participants'}], 'populationDescription': 'no patients were recruited in 2 arms'}}, 'protocolSection': {'designModule': {'phases': ['PHASE2'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'SINGLE', 'whoMasked': ['PARTICIPANT']}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 5}}, 'statusModule': {'whyStopped': 'lack of funding', 'overallStatus': 'TERMINATED', 'startDateStruct': {'date': '2010-06'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2019-10', 'completionDateStruct': {'date': '2013-12', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2019-10-03', 'studyFirstSubmitDate': '2010-06-30', 'resultsFirstSubmitDate': '2019-09-12', 'studyFirstSubmitQcDate': '2010-06-30', 'lastUpdatePostDateStruct': {'date': '2019-10-04', 'type': 'ACTUAL'}, 'resultsFirstSubmitQcDate': '2019-10-03', 'studyFirstPostDateStruct': {'date': '2010-07-01', 'type': 'ESTIMATED'}, 'resultsFirstPostDateStruct': {'date': '2019-10-04', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2013-12', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Insulin Resistance', 'timeFrame': '6 months', 'description': 'To compare the insulin sensitivity as measured by whole body glucose uptake during hyperinsulinemic euglycemic (HE) clamp in young T2D men with and without HH.'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'keywords': ['hypogonadism', 'diabetes', 'spermatogenesis', 'insulin resistance'], 'conditions': ['Hypogonadotropic Hypogonadism', 'Type 2 Diabetes']}, 'descriptionModule': {'briefSummary': 'Low testosterone production, known clinically as hypogonadism, appears to be common complication of type 2 diabetes, affecting one in three diabetic men. Hypogonadism is known to be associated with decreased muscle mass, increased fat mass, increased inflammation and decreased fertility. In this grant, the investigators propose to study the effects of having low testosterone on 1) insulin sensitivity, the ability of the body to handle glucose 2) fat and muscle mass at specific areas of the body 3) expression of mediators of inflammation in the blood 4) semen quality. This study will compare diabetic men (with or without hypogonadism). This study will also evaluate the effect of treatment with clomiphene (a drug that increases testosterone and sperm production) or testosterone in men with diabetes and hypogonadism. The investigators hope that this project will help us understand the state of hypogonadism in young type 2 diabetic men who are in their peak fertility years and give us insights into treatment of this condition. With the rising prevalence of type 2 diabetes in the young, this project may have implications for public health.', 'detailedDescription': 'This project will study young men with type 2 diabetes. We have shown that half of these men have low testosterone levels. This can lead to 1) Low muscle mass; 2) more fat mass; 3) insulin resistance; 4) low sperm count and 5) increased inflammation (that increases the risk of heart disease). This project will study these consequences in detail and also the possibility of reversing them with treatment. Information from this project will be useful in planning of future studies that will evaluate the effect of treatment of low testosterone on mortality, heart disease and stroke.'}, 'eligibilityModule': {'sex': 'MALE', 'stdAges': ['ADULT'], 'maximumAge': '40 Years', 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* T2D Males with age 18-40 years\n\nExclusion Criteria:\n\n1. planning to have children in the next one year\n2. Use of androgens, CC, hCG, aromatase inhibitors or over the counter health supplements which contain androgens currently or in the past 6 months;\n3. PSA \\> 4ng/ml, symptoms of severe BPH, prostate nodule or severe enlargement on digital rectal examination or h/o prostatic carcinoma\n4. Hemoglobin A1c \\> 8%\n5. Hematocrit \\> 50%\n6. History of obstructive sleep apnea\n7. Congestive heart failure\n8. Use of thiazolidinediones or exenatide\n9. currently suffering from depression, with or without treatment\n10. history of severe depression in the past which needed hospitalization\n11. currently suffering from foot ulcer, significant periodontal disease or any other chronic infectious condition\n12. Coronary event or procedure in the previous 6 months\n13. Hepatic disease (transaminase \\> 3 times normal) or cirrhosis\n14. Renal impairment (serum creatinine \\> 1.5)\n15. HIV or Hepatitis C positive status\n16. Participation in any other concurrent clinical trial'}, 'identificationModule': {'nctId': 'NCT01155518', 'briefTitle': 'Hypogonadism in Young Men With Type 2 Diabetes', 'organization': {'class': 'OTHER', 'fullName': 'State University of New York at Buffalo'}, 'officialTitle': 'Effect of Hypogonadotropic Hypogonadism and Replacement With Clomiphene Citrate and Testosterone on Insulin Sensitivity, Body Composition, Inflammation, Sexual Function and Spermatogenesis in Young Type 2 Diabetic Men', 'orgStudyIdInfo': {'id': '1-10-JF-13'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'testosterone', 'description': 'intramuscular injections every 2 weeks', 'interventionNames': ['Drug: testosterone']}, {'type': 'EXPERIMENTAL', 'label': 'clomiphene', 'description': 'oral drug thrice a week', 'interventionNames': ['Drug: clomiphene']}, {'type': 'PLACEBO_COMPARATOR', 'label': 'placebo for testosterone', 'description': 'placebo for testosterone arm', 'interventionNames': ['Drug: placebo']}, {'type': 'PLACEBO_COMPARATOR', 'label': 'placebo for clomiphene', 'description': 'oral placebo for clomiphene arm', 'interventionNames': ['Drug: placebo']}, {'type': 'NO_INTERVENTION', 'label': 'eugonadal obese', 'description': 'obese men with normal testosterone level'}, {'type': 'NO_INTERVENTION', 'label': 'lean', 'description': 'healthy lean men (control)'}], 'interventions': [{'name': 'testosterone', 'type': 'DRUG', 'description': 'intramuscular every 2 weeks', 'armGroupLabels': ['testosterone']}, {'name': 'clomiphene', 'type': 'DRUG', 'description': 'thrice a week', 'armGroupLabels': ['clomiphene']}, {'name': 'placebo', 'type': 'DRUG', 'description': 'intramuscular saline injections every 2 weeks', 'armGroupLabels': ['placebo for testosterone']}, {'name': 'placebo', 'type': 'DRUG', 'description': 'oral', 'armGroupLabels': ['placebo for clomiphene']}]}, 'contactsLocationsModule': {'locations': [{'zip': '14209', 'city': 'Buffalo', 'state': 'New York', 'country': 'United States', 'facility': 'Millard Fillmore Gates Hospital', 'geoPoint': {'lat': 42.88645, 'lon': -78.87837}}], 'overallOfficials': [{'name': 'Sandeep Dhindsa, MBBS', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'SUNY at Buffalo'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'State University of New York at Buffalo', 'class': 'OTHER'}, 'collaborators': [{'name': 'American Diabetes Association', 'class': 'OTHER'}], 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Assoc Prof of Medicine', 'investigatorFullName': 'sandeep dhindsa', 'investigatorAffiliation': 'State University of New York at Buffalo'}}}}