Ignite Creation Date:
2025-12-24 @ 11:43 PM
Ignite Modification Date:
2026-01-13 @ 7:53 AM
Study NCT ID:
NCT00656851
Status:
COMPLETED
Last Update Posted:
2013-08-28
First Post:
2008-04-10
Is NOT Gene Therapy:
True
Has Adverse Events:
True
Brief Title:
Myocardial Function & FFA Metabolism in HIV Metabolic Syndrome
Sponsor:
Organization:
Raw JSON
{'hasResults': True, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D015658', 'term': 'HIV Infections'}, {'id': 'D002318', 'term': 'Cardiovascular Diseases'}, {'id': 'D007333', 'term': 'Insulin Resistance'}, {'id': 'D000163', 'term': 'Acquired Immunodeficiency Syndrome'}, {'id': 'D006331', 'term': 'Heart Diseases'}, {'id': 'D003920', 'term': 'Diabetes Mellitus'}, {'id': 'D050171', 'term': 'Dyslipidemias'}], 'ancestors': [{'id': 'D000086982', 'term': 'Blood-Borne Infections'}, {'id': 'D003141', 'term': 'Communicable Diseases'}, {'id': 'D007239', 'term': 'Infections'}, {'id': 'D015229', 'term': 'Sexually Transmitted Diseases, Viral'}, {'id': 'D012749', 'term': 'Sexually Transmitted Diseases'}, {'id': 'D016180', 'term': 'Lentivirus Infections'}, {'id': 'D012192', 'term': 'Retroviridae Infections'}, {'id': 'D012327', 'term': 'RNA Virus Infections'}, {'id': 'D014777', 'term': 'Virus Diseases'}, {'id': 'D000091662', 'term': 'Genital Diseases'}, {'id': 'D000091642', 'term': 'Urogenital Diseases'}, {'id': 'D007153', 'term': 'Immunologic Deficiency Syndromes'}, {'id': 'D007154', 'term': 'Immune System Diseases'}, {'id': 'D006946', 'term': 'Hyperinsulinism'}, {'id': 'D044882', 'term': 'Glucose Metabolism Disorders'}, {'id': 'D008659', 'term': 'Metabolic Diseases'}, {'id': 'D009750', 'term': 'Nutritional and Metabolic Diseases'}, {'id': 'D012897', 'term': 'Slow Virus Diseases'}, {'id': 'D004700', 'term': 'Endocrine System Diseases'}, {'id': 'D052439', 'term': 'Lipid Metabolism Disorders'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D000077205', 'term': 'Pioglitazone'}, {'id': 'D015444', 'term': 'Exercise'}, {'id': 'D055070', 'term': 'Resistance Training'}], 'ancestors': [{'id': 'D045162', 'term': 'Thiazolidinediones'}, {'id': 'D013844', 'term': 'Thiazoles'}, {'id': 'D013457', 'term': 'Sulfur Compounds'}, {'id': 'D009930', 'term': 'Organic Chemicals'}, {'id': 'D001393', 'term': 'Azoles'}, {'id': 'D006573', 'term': 'Heterocyclic Compounds, 1-Ring'}, {'id': 'D006571', 'term': 'Heterocyclic Compounds'}, {'id': 'D009043', 'term': 'Motor Activity'}, {'id': 'D009068', 'term': 'Movement'}, {'id': 'D009142', 'term': 'Musculoskeletal Physiological Phenomena'}, {'id': 'D055687', 'term': 'Musculoskeletal and Neural Physiological Phenomena'}, {'id': 'D005081', 'term': 'Exercise Therapy'}, {'id': 'D012046', 'term': 'Rehabilitation'}, {'id': 'D000359', 'term': 'Aftercare'}, {'id': 'D003266', 'term': 'Continuity of Patient Care'}, {'id': 'D005791', 'term': 'Patient Care'}, {'id': 'D013812', 'term': 'Therapeutics'}, {'id': 'D026741', 'term': 'Physical Therapy Modalities'}, {'id': 'D064797', 'term': 'Physical Conditioning, Human'}]}}, 'resultsSection': {'moreInfoModule': {'pointOfContact': {'email': 'key@wustl.edu', 'phone': '3143628173', 'title': 'Kevin Yarasheski, PhD', 'organization': 'Washington Univ Med Sch'}, 'certainAgreement': {'piSponsorEmployee': False, 'restrictiveAgreement': False}, 'limitationsAndCaveats': {'description': 'We did not perform the myocardial metabolic measurements under insulin-stimulated conditions (i.e. hyperinsulinemic clamps). Small number of participants and high measurement variability, efficacy was not found. Study ended to minimize risk/benefit.'}}, 'adverseEventsModule': {'eventGroups': [{'id': 'EG000', 'title': 'Pioglitazone', 'description': 'Pioglitazone (Actos, 30mg/day for 16 weeks)', 'otherNumAtRisk': 12, 'otherNumAffected': 0, 'seriousNumAtRisk': 12, 'seriousNumAffected': 0}, {'id': 'EG001', 'title': 'Exercise Training', 'description': 'Cardiorespiratory and resistance exercise training 3days/wk for 16 weeks', 'otherNumAtRisk': 8, 'otherNumAffected': 0, 'seriousNumAtRisk': 8, 'seriousNumAffected': 0}], 'frequencyThreshold': '1'}, 'outcomeMeasuresModule': {'outcomeMeasures': [{'type': 'PRIMARY', 'title': 'Myocardial Glucose Utilization Rate', 'denoms': [{'units': 'Participants', 'counts': [{'value': '12', 'groupId': 'OG000'}, {'value': '8', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Pioglitazone', 'description': 'Pioglitazone (Actos, 30mg/day for 16 weeks)'}, {'id': 'OG001', 'title': 'Exercise Training', 'description': 'Cardiorespiratory and resistance exercise training 3days/wk for 16 weeks'}], 'classes': [{'title': 'Week 0', 'categories': [{'measurements': [{'value': '109.6', 'spread': '70.5', 'groupId': 'OG000'}, {'value': '106.7', 'spread': '69.0', 'groupId': 'OG001'}]}]}, {'title': 'Week 16', 'categories': [{'measurements': [{'value': '109.1', 'spread': '55.2', 'groupId': 'OG000'}, {'value': '87.2', 'spread': '97.4', 'groupId': 'OG001'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Weeks 0 and 16', 'description': 'Radio-tracer (11C-glucose) and positron emission tomography quantification of myocardial glucose utilization rate. The rate at which glucose exits the blood, enters the muscle cells in the left ventricle, and is metabolized (ATP generation, glycolysis, glycogenolysis, or lactate production). Total glucose utilization rate in the left ventricle of the heart.', 'unitOfMeasure': '(nmol glucose/g heart muscle/min', 'dispersionType': 'Standard Error', 'reportingStatus': 'POSTED'}, {'type': 'SECONDARY', 'title': 'Myocardial Contractile Function During Diastole', 'denoms': [{'units': 'Participants', 'counts': [{'value': '12', 'groupId': 'OG000'}, {'value': '8', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Pioglitazone', 'description': 'Pioglitazone (Actos, 30mg/day for 16 weeks)'}, {'id': 'OG001', 'title': 'Exercise Training', 'description': 'Cardiorespiratory and resistance exercise training 3days/wk for 16 weeks'}], 'classes': [{'title': 'Week 0', 'categories': [{'measurements': [{'value': '1.4', 'spread': '0.6', 'groupId': 'OG000'}, {'value': '1.4', 'spread': '0.3', 'groupId': 'OG001'}]}]}, {'title': 'Week 16', 'categories': [{'measurements': [{'value': '1.4', 'spread': '0.5', 'groupId': 'OG000'}, {'value': '1.5', 'spread': '0.2', 'groupId': 'OG001'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Weeks 0 and 16', 'description': 'Echocardiographic quantification of (E/A) early to late diastolic filling velocity. Aria transfer blood to the ventricles in 2 steps:\n\n1. blood collected in the atria falls into the ventricles when the atrioventricular valves opens. In the left heart, the velocity at which the blood moves during this initial action is called the early or "E" filling velocity.\n2. residual blood in the atria, is emptied during diastole by atrial contraction. The velocity of the blood during atrial contraction is the "A" (for atrial) filling velocity. These are expressed as a ratio (E/A). If A exceeds E velocity (ratio \\<1.0) this is a clinical marker of diastolic dysfunction. This can occur when the left ventricular wall becomes so stiff as to impair proper filling, which can lead to diastolic heart failure.', 'unitOfMeasure': 'ratio', 'dispersionType': 'Standard Error', 'reportingStatus': 'POSTED'}, {'type': 'SECONDARY', 'title': 'Myocardial Contractile Function During Systole', 'denoms': [{'units': 'Participants', 'counts': [{'value': '12', 'groupId': 'OG000'}, {'value': '8', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Pioglitazone', 'description': 'Pioglitazone (Actos, 30mg/day for 16 weeks)'}, {'id': 'OG001', 'title': 'Exercise Training', 'description': 'Cardiorespiratory and resistance exercise training 3days/wk for 16 weeks'}], 'classes': [{'title': 'Week 0', 'categories': [{'measurements': [{'value': '12.7', 'spread': '1.8', 'groupId': 'OG000'}, {'value': '13.1', 'spread': '2.4', 'groupId': 'OG001'}]}]}, {'title': 'Week 16', 'categories': [{'measurements': [{'value': '12.8', 'spread': '1.6', 'groupId': 'OG000'}, {'value': '13.6', 'spread': '0.4', 'groupId': 'OG001'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Weeks 0 and 16', 'description': "Echocardiographic quantification of E' wall velocity during systole averaged at the lateral wall and septum", 'unitOfMeasure': 'cm/sec', 'dispersionType': 'Standard Error', 'reportingStatus': 'POSTED'}, {'type': 'PRIMARY', 'title': 'Myocardial Glucose Utilization Rate Per Unit Insulin', 'denoms': [{'units': 'Participants', 'counts': [{'value': '12', 'groupId': 'OG000'}, {'value': '8', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Pioglitazone', 'description': 'Pioglitazone (Actos, 30mg/day for 16 weeks)'}, {'id': 'OG001', 'title': 'Exercise Training', 'description': 'Cardiorespiratory and resistance exercise training 3days/wk for 16 weeks'}], 'classes': [{'title': 'Week 0', 'categories': [{'measurements': [{'value': '14.9', 'spread': '22.1', 'groupId': 'OG000'}, {'value': '11.9', 'spread': '11.0', 'groupId': 'OG001'}]}]}, {'title': 'Week 16', 'categories': [{'measurements': [{'value': '15.7', 'spread': '12.4', 'groupId': 'OG000'}, {'value': '21.7', 'spread': '40.8', 'groupId': 'OG001'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Weeks 0 and 16', 'description': 'Radio-tracer (11C-glucose) and positron emission tomography quantification of myocardial glucose utilization rate per unit of plasma insulin. Total glucose utilization rate in the left ventricle of the heart expressed per unit of the circulating plasma insulin concentration.', 'unitOfMeasure': '(nmol glucose/g heart muscle/min/µU insu', 'dispersionType': 'Standard Error', 'reportingStatus': 'POSTED'}, {'type': 'PRIMARY', 'title': 'Myocardial Fatty Acid Utilization Rate', 'denoms': [{'units': 'Participants', 'counts': [{'value': '12', 'groupId': 'OG000'}, {'value': '8', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Pioglitazone', 'description': 'Pioglitazone (Actos, 30mg/day for 16 weeks)'}, {'id': 'OG001', 'title': 'Exercise Training', 'description': 'Cardiorespiratory and resistance exercise training 3days/wk for 16 weeks'}], 'classes': [{'title': 'Week 0', 'categories': [{'measurements': [{'value': '119.3', 'spread': '39.8', 'groupId': 'OG000'}, {'value': '119.8', 'spread': '48.7', 'groupId': 'OG001'}]}]}, {'title': 'Week 16', 'categories': [{'measurements': [{'value': '129.3', 'spread': '34.5', 'groupId': 'OG000'}, {'value': '130.4', 'spread': '55.2', 'groupId': 'OG001'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Weeks 0 and 16', 'description': 'Radio-tracer (11C-palmitate) and positron emission tomography quantification of myocardial fatty acid utilization rate. The rate at which palmitate exits the blood, enters the muscle cells in the left ventricle, and is metabolized (oxidation, re-esterification).', 'unitOfMeasure': '(nmol palmitate/g heart muscle/min', 'dispersionType': 'Standard Error', 'reportingStatus': 'POSTED'}, {'type': 'PRIMARY', 'title': 'Myocardial Fatty Acid Oxidation Rate', 'denoms': [{'units': 'Participants', 'counts': [{'value': '12', 'groupId': 'OG000'}, {'value': '8', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Pioglitazone', 'description': 'Pioglitazone (Actos, 30mg/day for 16 weeks)'}, {'id': 'OG001', 'title': 'Exercise Training', 'description': 'Cardiorespiratory and resistance exercise training 3days/wk for 16 weeks'}], 'classes': [{'title': 'Week 0', 'categories': [{'measurements': [{'value': '92.4', 'spread': '27.5', 'groupId': 'OG000'}, {'value': '106.3', 'spread': '49.6', 'groupId': 'OG001'}]}]}, {'title': 'Week 16', 'categories': [{'measurements': [{'value': '110.1', 'spread': '31.7', 'groupId': 'OG000'}, {'value': '97.5', 'spread': '36.6', 'groupId': 'OG001'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Weeks 0 and 16', 'description': 'Radio-tracer (11C-palmitate) and positron emission tomography quantification of myocardial fatty acid oxidation rate.', 'unitOfMeasure': '(nmol palmitate/g heart muscle/min', 'dispersionType': 'Standard Error', 'reportingStatus': 'POSTED'}, {'type': 'PRIMARY', 'title': 'Myocardial Fatty Acid Esterification', 'denoms': [{'units': 'Participants', 'counts': [{'value': '12', 'groupId': 'OG000'}, {'value': '8', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Pioglitazone', 'description': 'Pioglitazone (Actos, 30mg/day for 16 weeks)'}, {'id': 'OG001', 'title': 'Exercise Training', 'description': 'Cardiorespiratory and resistance exercise training 3days/wk for 16 weeks'}], 'classes': [{'title': 'Week 0', 'categories': [{'measurements': [{'value': '7', 'spread': '7', 'groupId': 'OG000'}, {'value': '4', 'spread': '3', 'groupId': 'OG001'}]}]}, {'title': 'Week 16', 'categories': [{'measurements': [{'value': '4', 'spread': '5', 'groupId': 'OG000'}, {'value': '7', 'spread': '5', 'groupId': 'OG001'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Weeks 0 and 16', 'description': 'Radio-tracer (11C-palmitate) and positron emission tomography quantification of myocardial fatty acid esterification as a % of total fatty acid extraction', 'unitOfMeasure': '(% of total fatty acid extraction)', 'dispersionType': 'Standard Error', 'reportingStatus': 'POSTED'}, {'type': 'SECONDARY', 'title': 'Fasting Lipids and Lipoproteins', 'denoms': [{'units': 'Participants', 'counts': [{'value': '12', 'groupId': 'OG000'}, {'value': '8', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Pioglitazone', 'description': 'Pioglitazone (Actos, 30mg/day for 16 weeks)'}, {'id': 'OG001', 'title': 'Exercise Training', 'description': 'Cardiorespiratory and resistance exercise training 3days/wk for 16 weeks'}], 'classes': [{'title': 'triglycerides wk 0', 'categories': [{'measurements': [{'value': '199', 'spread': '119', 'groupId': 'OG000'}, {'value': '185', 'spread': '58', 'groupId': 'OG001'}]}]}, {'title': 'triglycerides wk 16', 'categories': [{'measurements': [{'value': '182', 'spread': '91', 'groupId': 'OG000'}, {'value': '159', 'spread': '33', 'groupId': 'OG001'}]}]}, {'title': 'LDL-cholesterol wk 0', 'categories': [{'measurements': [{'value': '115', 'spread': '36', 'groupId': 'OG000'}, {'value': '112', 'spread': '26', 'groupId': 'OG001'}]}]}, {'title': 'LDL-cholesterol wk 16', 'categories': [{'measurements': [{'value': '97', 'spread': '17', 'groupId': 'OG000'}, {'value': '90', 'spread': '24', 'groupId': 'OG001'}]}]}, {'title': 'HDL-cholesterol wk 0', 'categories': [{'measurements': [{'value': '38.9', 'spread': '11.0', 'groupId': 'OG000'}, {'value': '38.1', 'spread': '8.4', 'groupId': 'OG001'}]}]}, {'title': 'HDL-cholesterol wk 16', 'categories': [{'measurements': [{'value': '38.8', 'spread': '12.4', 'groupId': 'OG000'}, {'value': '39.8', 'spread': '21.8', 'groupId': 'OG001'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Week 0 and 16', 'description': 'fasting serum triglycerides, LDL-, and HDL-cholesterol concentrations', 'unitOfMeasure': 'mg/dL', 'dispersionType': 'Standard Error', 'reportingStatus': 'POSTED'}, {'type': 'SECONDARY', 'title': 'Fasting Glucose Insulin and HOMA', 'denoms': [{'units': 'Participants', 'counts': [{'value': '12', 'groupId': 'OG000'}, {'value': '8', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Pioglitazone', 'description': 'Pioglitazone (Actos, 30mg/day for 16 weeks)'}, {'id': 'OG001', 'title': 'Exercise Training', 'description': 'Cardiorespiratory and resistance exercise training 3days/wk for 16 weeks'}], 'classes': [{'title': 'glucose (mg/dL) wk 0', 'categories': [{'measurements': [{'value': '102', 'spread': '15', 'groupId': 'OG000'}, {'value': '91.9', 'spread': '9.5', 'groupId': 'OG001'}]}]}, {'title': 'glucose wk 16', 'categories': [{'measurements': [{'value': '95.3', 'spread': '13', 'groupId': 'OG000'}, {'value': '86.8', 'spread': '8.2', 'groupId': 'OG001'}]}]}, {'title': 'insulin (µU/mL) wk 0', 'categories': [{'measurements': [{'value': '20.5', 'spread': '25.7', 'groupId': 'OG000'}, {'value': '14.8', 'spread': '8.4', 'groupId': 'OG001'}]}]}, {'title': 'insulin wk 16', 'categories': [{'measurements': [{'value': '11.4', 'spread': '9.6', 'groupId': 'OG000'}, {'value': '11.8', 'spread': '7.6', 'groupId': 'OG001'}]}]}, {'title': 'HOMA-IR wk 0', 'categories': [{'measurements': [{'value': '6.1', 'spread': '10.4', 'groupId': 'OG000'}, {'value': '3.3', 'spread': '1.7', 'groupId': 'OG001'}]}]}, {'title': 'HOMA-IR wk 16', 'categories': [{'measurements': [{'value': '2.8', 'spread': '2.7', 'groupId': 'OG000'}, {'value': '2.6', 'spread': '1.6', 'groupId': 'OG001'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Week 0 and 16', 'description': 'fasting plasma glucose, insulin concentrations and HOMA-insulin resistance', 'unitOfMeasure': 'mg/dL µU/mL', 'dispersionType': 'Standard Error', 'reportingStatus': 'POSTED'}]}, 'participantFlowModule': {'groups': [{'id': 'FG000', 'title': 'Pioglitazone', 'description': 'Pioglitazone (Actos, 30mg/day for 16 weeks)'}, {'id': 'FG001', 'title': 'Exercise Training', 'description': 'Cardiorespiratory and resistance exercise training 3days/wk for 16 weeks'}], 'periods': [{'title': 'Overall Study', 'milestones': [{'type': 'STARTED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '12'}, {'groupId': 'FG001', 'numSubjects': '12'}]}, {'type': 'COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '12'}, {'groupId': 'FG001', 'numSubjects': '8'}]}, {'type': 'NOT COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '0'}, {'groupId': 'FG001', 'numSubjects': '4'}]}], 'dropWithdraws': [{'type': 'Withdrawal by Subject', 'reasons': [{'groupId': 'FG000', 'numSubjects': '0'}, {'groupId': 'FG001', 'numSubjects': '4'}]}]}], 'recruitmentDetails': 'Twenty four participants were enrolled from the AIDS Clinical Trials Unit and Infectious Diseases Clinics at Washington University School of Medicine in St. Louis, Missouri, USA. This was a prospective, two-group, random assignment study.', 'preAssignmentDetails': 'Exclusion criteria: medications or dietary supplements that affect metabolism (β-blocker, β-agonist, Ca2+ channel blocker, corticosteroid), neuromuscular disorder that affects metabolism or ability to exercise, consumed \\>3 alcohol drinks/wk, active Hep C or B, recreational-anabolic -appetite stimulant drugs, regular physical exercise.'}, 'baselineCharacteristicsModule': {'denoms': [{'units': 'Participants', 'counts': [{'value': '12', 'groupId': 'BG000'}, {'value': '12', 'groupId': 'BG001'}, {'value': '24', 'groupId': 'BG002'}]}], 'groups': [{'id': 'BG000', 'title': 'Pioglitazone', 'description': 'Pioglitazone (Actos, 30mg/day for 16 weeks)'}, {'id': 'BG001', 'title': 'Exercise Training', 'description': 'Cardiorespiratory and resistance exercise training 3days/wk for 16 weeks'}, {'id': 'BG002', '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'}]}, {'title': 'Between 18 and 65 years', 'measurements': [{'value': '12', 'groupId': 'BG000'}, {'value': '12', 'groupId': 'BG001'}, {'value': '24', 'groupId': 'BG002'}]}, {'title': '>=65 years', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Age Continuous', 'classes': [{'categories': [{'measurements': [{'value': '42', 'spread': '7', 'groupId': 'BG000'}, {'value': '41', 'spread': '6', 'groupId': 'BG001'}, {'value': '42', 'spread': '6', 'groupId': 'BG002'}]}]}], 'paramType': 'MEAN', 'unitOfMeasure': 'years', 'dispersionType': 'STANDARD_DEVIATION'}, {'title': 'Sex: Female, Male', 'classes': [{'categories': [{'title': 'Female', 'measurements': [{'value': '3', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '3', 'groupId': 'BG002'}]}, {'title': 'Male', 'measurements': [{'value': '9', 'groupId': 'BG000'}, {'value': '12', 'groupId': 'BG001'}, {'value': '21', 'groupId': 'BG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Region of Enrollment', 'classes': [{'title': 'United States', 'categories': [{'measurements': [{'value': '12', 'groupId': 'BG000'}, {'value': '12', 'groupId': 'BG001'}, {'value': '24', 'groupId': 'BG002'}]}]}], 'paramType': 'NUMBER', 'unitOfMeasure': 'participants'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'DIAGNOSTIC', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 24}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2005-09'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2013-08', 'completionDateStruct': {'date': '2010-08', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2013-08-19', 'studyFirstSubmitDate': '2008-04-10', 'resultsFirstSubmitDate': '2013-04-30', 'studyFirstSubmitQcDate': '2008-04-10', 'lastUpdatePostDateStruct': {'date': '2013-08-28', 'type': 'ESTIMATED'}, 'resultsFirstSubmitQcDate': '2013-07-16', 'studyFirstPostDateStruct': {'date': '2008-04-11', 'type': 'ESTIMATED'}, 'resultsFirstPostDateStruct': {'date': '2013-08-20', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2009-08', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Myocardial Glucose Utilization Rate', 'timeFrame': 'Weeks 0 and 16', 'description': 'Radio-tracer (11C-glucose) and positron emission tomography quantification of myocardial glucose utilization rate. The rate at which glucose exits the blood, enters the muscle cells in the left ventricle, and is metabolized (ATP generation, glycolysis, glycogenolysis, or lactate production). Total glucose utilization rate in the left ventricle of the heart.'}, {'measure': 'Myocardial Glucose Utilization Rate Per Unit Insulin', 'timeFrame': 'Weeks 0 and 16', 'description': 'Radio-tracer (11C-glucose) and positron emission tomography quantification of myocardial glucose utilization rate per unit of plasma insulin. Total glucose utilization rate in the left ventricle of the heart expressed per unit of the circulating plasma insulin concentration.'}, {'measure': 'Myocardial Fatty Acid Utilization Rate', 'timeFrame': 'Weeks 0 and 16', 'description': 'Radio-tracer (11C-palmitate) and positron emission tomography quantification of myocardial fatty acid utilization rate. The rate at which palmitate exits the blood, enters the muscle cells in the left ventricle, and is metabolized (oxidation, re-esterification).'}, {'measure': 'Myocardial Fatty Acid Oxidation Rate', 'timeFrame': 'Weeks 0 and 16', 'description': 'Radio-tracer (11C-palmitate) and positron emission tomography quantification of myocardial fatty acid oxidation rate.'}, {'measure': 'Myocardial Fatty Acid Esterification', 'timeFrame': 'Weeks 0 and 16', 'description': 'Radio-tracer (11C-palmitate) and positron emission tomography quantification of myocardial fatty acid esterification as a % of total fatty acid extraction'}], 'secondaryOutcomes': [{'measure': 'Myocardial Contractile Function During Diastole', 'timeFrame': 'Weeks 0 and 16', 'description': 'Echocardiographic quantification of (E/A) early to late diastolic filling velocity. Aria transfer blood to the ventricles in 2 steps:\n\n1. blood collected in the atria falls into the ventricles when the atrioventricular valves opens. In the left heart, the velocity at which the blood moves during this initial action is called the early or "E" filling velocity.\n2. residual blood in the atria, is emptied during diastole by atrial contraction. The velocity of the blood during atrial contraction is the "A" (for atrial) filling velocity. These are expressed as a ratio (E/A). If A exceeds E velocity (ratio \\<1.0) this is a clinical marker of diastolic dysfunction. This can occur when the left ventricular wall becomes so stiff as to impair proper filling, which can lead to diastolic heart failure.'}, {'measure': 'Myocardial Contractile Function During Systole', 'timeFrame': 'Weeks 0 and 16', 'description': "Echocardiographic quantification of E' wall velocity during systole averaged at the lateral wall and septum"}, {'measure': 'Fasting Lipids and Lipoproteins', 'timeFrame': 'Week 0 and 16', 'description': 'fasting serum triglycerides, LDL-, and HDL-cholesterol concentrations'}, {'measure': 'Fasting Glucose Insulin and HOMA', 'timeFrame': 'Week 0 and 16', 'description': 'fasting plasma glucose, insulin concentrations and HOMA-insulin resistance'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'keywords': ['HIV/AIDS', 'Heart disease', 'Diabetes', 'Cardiovascular disease risk', 'Dyslipidemia', 'Visceral adiposity', 'treatment experienced'], 'conditions': ['HIV Infections', 'Cardiovascular Disease', 'Insulin Resistance', 'HIV Lipodystrophy', 'The Metabolic Syndrome']}, 'referencesModule': {'references': [{'pmid': '22151886', 'type': 'RESULT', 'citation': 'Cade WT, Reeds DN, Overton ET, Herrero P, Waggoner AD, Davila-Roman VG, Lassa-Claxton S, Gropler RJ, Soto PF, Krauss MJ, Yarasheski KE, Peterson LR. Effects of human immunodeficiency virus and metabolic complications on myocardial nutrient metabolism, blood flow, and oxygen consumption: a cross-sectional analysis. Cardiovasc Diabetol. 2011 Dec 8;10:111. doi: 10.1186/1475-2840-10-111.'}, {'pmid': '23574474', 'type': 'RESULT', 'citation': 'Cade WT, Overton ET, Mondy K, de las Fuentes L, Davila-Roman VG, Waggoner AD, Reeds DN, Lassa-Claxton S, Krauss MJ, Peterson LR, Yarasheski KE. Relationships among HIV infection, metabolic risk factors, and left ventricular structure and function. AIDS Res Hum Retroviruses. 2013 Aug;29(8):1151-60. doi: 10.1089/AID.2012.0254. Epub 2013 May 6.'}, {'pmid': '20959530', 'type': 'RESULT', 'citation': 'Yarasheski KE, Cade WT, Overton ET, Mondy KE, Hubert S, Laciny E, Bopp C, Lassa-Claxton S, Reeds DN. Exercise training augments the peripheral insulin-sensitizing effects of pioglitazone in HIV-infected adults with insulin resistance and central adiposity. Am J Physiol Endocrinol Metab. 2011 Jan;300(1):E243-51. doi: 10.1152/ajpendo.00468.2010. Epub 2010 Oct 19.'}]}, 'descriptionModule': {'briefSummary': "We hypothesize that the hearts of HIV+ people with The Metabolic Syndrome use and oxidize fats and sugars inappropriately, and that this may impair the heart's ability to pump blood. We hypothesize that exercise training or pioglitazone (Actos) will improve fat and sugar metabolism in the hearts of HIV+ people with The Metabolic Syndrome. This study will advance our understanding of cardiovascular disease in HIV+ people, and will test the efficacy of exercise training and pioglitazone for improving insulin resistance, heart metabolism and heart function in this at risk population.", 'detailedDescription': 'We hypothesize that myocardial free fatty acid and glucose utilization and oxidation rates are dysregulated in HIV+ people with The Metabolic Syndrome in comparison to HIV+ people without The Metabolic Syndrome, and in comparison to HIV-seronegative people with and without The Metabolic Syndrome. We hypothesize that dysregulated myocardial fatty acid and glucose metabolism is associated with impaired heart function (diastolic dysfunction) in HIV+ people with The Metabolic Syndrome. We will use myocardial positron emission tomography, radioactive isotope tracers of palmitate and glucose, and echocardiography to evaluate myocardial metabolism and function. HIV+ people with The Metabolic Syndrome will receive 16wks of exercise training or pioglitazone (Actos), and we will evaluate their potential beneficial effects on myocardial metabolism and function.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT'], 'maximumAge': '50 Years', 'minimumAge': '28 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria: All participants both with and without metabolic syndrome:\n\n1. 28-50 years old.\n2. Plasma HIV RNA less than 5,000 copies/mL for previous 3 months OR CD4 count greater than 100 cells/µL for previous 3 months.\n3. Stable for at least the past 3 months on any HAART regimen.\n4. "Normal" blood chemistries for at least 1 month prior to enrollment: platelet count \\>50,000/mm3, absolute neutrophil count \\>750/mm3, liver transaminases \\<2.5x the upper limit of normal (ULN), creatinine \\<1.3x ULN, albumin \\>30g/L, creatine kinase \\<5.9x ULN.\n\nMenstruating women must have a negative urine beta-HCG pregnancy test within 14 days prior to study. To control for potential metabolic effects of alterations in female hormones during the menstrual cycle, all menstruating women will be studied during the follicular phase (serum 17beta-estradiol \\<165 pg/mL).\n\nExclusion Criteria:\n\n1. Frank obesity (BMI \\>35kg/m2).\n2. Chronic hepatitis B infection (HB surface antigen positive). Active hepatitis C infection (detectable Hep C RNA). Those who have cleared hepatitis B or C infection are eligible.\n3. Diabetes \\[fasting glucose \\>125 mg/dL, or fasting insulin \\>45 µU/mL, or 2-hr glucose \\>200mg/dL\\].\n4. Medications or agents that regulate glucose metabolism (e.g., insulin-sensitizers, insulin-secretagogues). Lipid lowering agents that regulate lipid metabolism (i.e. fibrate, statin).\n5. Gestational diabetes, pregnancy, or nursing mothers.\n6. Serum triglycerides ≥ 500 mg/dL.\n7. Hypogonadism \\[total testosterone \\<200ng/dL (men) or \\<15ng/dL (women)\\]; thyroid disorder \\[TSH \\<0.2 or \\>12µIU/mL\\]; hypercortisolemia \\[morning cortisol \\>22µg/dL\\]. Replacement testosterone or thyroid hormones to normalize abnormal levels is acceptable, as long as treatment and blood levels have been stable for at least 3 months.\n8. Use of human growth hormone (hGH) or GH-secretagogues (GH-releasing hormone-peptides) within the previous 3 months.\n9. History of serious cardiovascular disease; MI, angina pectoris, heart failure, congenital heart disease, coronary artery disease, coronary artery bypass graft, stroke. Bundle branch block is exclusionary because it limits the interpretability of the resting/exercise ECG. Cardiovascular or physical contraindications to maximal exercise testing on a cycle ergometer.\n10. Uncontrolled hypertension (\\>140/90 mmHg). Certain antihypertensive medications will be permitted (diuretics, ACE inhibitors) as long as the medication, dose, and blood pressure have been stable for at least 3 months.\n11. Well-trained athletes (defined as \\>3 exercise training exposures/week; \\>30min regimented exercise/exposure maintained for at least the prior 4 weeks).\n12. History of or active substance abuse (eg, alcoholism, cocaine, heroin, crack, methamphetamine, phencyclidine).\n13. Active secondary infection. Any significant change in chronic suppressive therapy for an opportunistic infection during 1 month prior to enrollment.\n14. New serious systemic infection during the 3 weeks prior to enrollment.\n15. History of hyperlactatemia or lactic acidosis, esp. with rapid weight loss.\n16. Debilitating-painful myopathy or neuropathy that requires \'assistance\' to conduct normal activities of daily living (dressing, hygiene, preparing meals, operating a vehicle). These might affect peripheral substrate metabolism.\n17. Chronic renal insufficiency/failure or other comorbid conditions (eg. cancer, COPD) that alter metabolism.\n18. Pancreatitis, celiac disease, or cirrhosis.\n19. Inadequate macronutrient or energy intake, or malabsorptive disorder.\n20. Dementia or any condition that would prevent voluntary informed consent or compliance.\n21. Other compounds or blinded investigational new drugs that might affect metabolism or confound data interpretation (eg. RU486, interleukin therapy, or cytokine-receptor antagonist).\n22. Oral glucocorticoid or corticosteroid use within previous 3 months.'}, 'identificationModule': {'nctId': 'NCT00656851', 'acronym': 'WU197', 'briefTitle': 'Myocardial Function & FFA Metabolism in HIV Metabolic Syndrome', 'organization': {'class': 'NIH', 'fullName': 'National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)'}, 'officialTitle': 'Myocardial Function, Free Fatty Acid and Glucose Metabolism in HIV Metabolic Syndrome', 'orgStudyIdInfo': {'id': 'DK59531 (completed)'}, 'secondaryIdInfos': [{'id': 'HRPO 05-0976'}]}, 'armsInterventionsModule': {'armGroups': [{'type': 'ACTIVE_COMPARATOR', 'label': 'Pioglitazone', 'description': 'Pioglitazone (Actos, 30mg/day for 16 weeks)', 'interventionNames': ['Drug: Pioglitazone']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'Exercise Training', 'description': 'Cardiorespiratory and resistance exercise training 3days/wk for 16 weeks', 'interventionNames': ['Behavioral: Exercise Training']}], 'interventions': [{'name': 'Pioglitazone', 'type': 'DRUG', 'otherNames': ['Actos'], 'description': '30mg/day for 16 weeks', 'armGroupLabels': ['Pioglitazone']}, {'name': 'Exercise Training', 'type': 'BEHAVIORAL', 'otherNames': ['Physical activity', 'Aerobic exercise', 'Weight lifting exercise'], 'description': 'Cardiorespiratory and resistance exercise training 3days/wk for 16 weeks', 'armGroupLabels': ['Exercise Training']}]}, 'contactsLocationsModule': {'locations': [{'zip': '63110', 'city': 'St Louis', 'state': 'Missouri', 'country': 'United States', 'facility': 'Washington University School of Medicine', 'geoPoint': {'lat': 38.62727, 'lon': -90.19789}}], 'overallOfficials': [{'name': 'Kevin Yarasheski, PhD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Washington University School of Medicine'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)', 'class': 'NIH'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Professor of Medicine', 'investigatorFullName': 'Kevin Yarasheski', 'investigatorAffiliation': 'Washington University School of Medicine'}}}}