Ignite Creation Date:
2025-12-24 @ 5:12 PM
Ignite Modification Date:
2025-12-28 @ 12:02 PM
Study NCT ID:
NCT00408850
Status:
UNKNOWN
Last Update Posted:
2013-01-17
First Post:
2006-12-06
Is Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Effects of Pioglitazone Treatment on Sympathetic Nervous System Function in Metabolic Syndrome Obesity
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D024821', 'term': 'Metabolic Syndrome'}], 'ancestors': [{'id': 'D007333', 'term': 'Insulin Resistance'}, {'id': 'D006946', 'term': 'Hyperinsulinism'}, {'id': 'D044882', 'term': 'Glucose Metabolism Disorders'}, {'id': 'D008659', 'term': 'Metabolic Diseases'}, {'id': 'D009750', 'term': 'Nutritional and Metabolic Diseases'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D000077205', 'term': 'Pioglitazone'}, {'id': 'D000073893', 'term': 'Sugars'}, {'id': 'D007785', 'term': 'Lactose'}], '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': 'D002241', 'term': 'Carbohydrates'}, {'id': 'D004187', 'term': 'Disaccharides'}, {'id': 'D009844', 'term': 'Oligosaccharides'}, {'id': 'D011134', 'term': 'Polysaccharides'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE3'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'DOUBLE', 'whoMasked': ['PARTICIPANT', 'INVESTIGATOR']}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 44}}, 'statusModule': {'overallStatus': 'UNKNOWN', 'lastKnownStatus': 'RECRUITING', 'startDateStruct': {'date': '2008-11'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2013-01', 'completionDateStruct': {'date': '2013-02', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2013-01-16', 'studyFirstSubmitDate': '2006-12-06', 'studyFirstSubmitQcDate': '2006-12-06', 'lastUpdatePostDateStruct': {'date': '2013-01-17', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2006-12-07', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2013-02', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Sympathetic nervous system activity, measured as muscle sympathetic nervous activity and whole-body noradrenaline spillover', 'timeFrame': '12 weeks treatment'}], 'secondaryOutcomes': [{'measure': 'Baroreflex function, adrenoceptor expression', 'timeFrame': '12 weeks treatment'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'keywords': ['sympathetic nervous system, pioglitazone, metabolic syndrome'], 'conditions': ['Metabolic Syndrome']}, 'referencesModule': {'references': [{'pmid': '17000932', 'type': 'BACKGROUND', 'citation': 'Esler M, Straznicky N, Eikelis N, Masuo K, Lambert G, Lambert E. Mechanisms of sympathetic activation in obesity-related hypertension. Hypertension. 2006 Nov;48(5):787-96. doi: 10.1161/01.HYP.0000242642.42177.49. Epub 2006 Sep 25. No abstract available.'}, {'pmid': '16091482', 'type': 'BACKGROUND', 'citation': 'Straznicky NE, Lambert EA, Lambert GW, Masuo K, Esler MD, Nestel PJ. Effects of dietary weight loss on sympathetic activity and cardiac risk factors associated with the metabolic syndrome. J Clin Endocrinol Metab. 2005 Nov;90(11):5998-6005. doi: 10.1210/jc.2005-0961. Epub 2005 Aug 9.'}, {'pmid': '26297500', 'type': 'DERIVED', 'citation': 'Straznicky NE, Grima MT, Sari CI, Lambert EA, Phillips SE, Eikelis N, Kobayashi D, Hering D, Mariani JA, Dixon JB, Nestel PJ, Karapanagiotidis S, Schlaich MP, Lambert GW. Reduction in peripheral vascular resistance predicts improvement in insulin clearance following weight loss. Cardiovasc Diabetol. 2015 Aug 22;14:113. doi: 10.1186/s12933-015-0276-2.'}, {'pmid': '25827058', 'type': 'DERIVED', 'citation': 'Straznicky NE, Grima MT, Sari CI, Eikelis N, Lambert GW, Nestel PJ, Richards K, Dixon JB, Schlaich MP, Lambert EA. Pioglitazone treatment enhances the sympathetic nervous system response to oral carbohydrate load in obese individuals with metabolic syndrome. Metabolism. 2015 Jul;64(7):797-803. doi: 10.1016/j.metabol.2015.03.006. Epub 2015 Mar 18.'}, {'pmid': '25590214', 'type': 'DERIVED', 'citation': 'Straznicky NE, Grima MT, Lambert EA, Sari CI, Eikelis N, Nestel PJ, Phillips SE, Hering D, Karapanagiotidis S, Dixon JB, Schlaich MP, Lambert GW. Arterial norepinephrine concentration is inversely and independently associated with insulin clearance in obese individuals with metabolic syndrome. J Clin Endocrinol Metab. 2015 Apr;100(4):1544-50. doi: 10.1210/jc.2014-3796. Epub 2015 Jan 15.'}, {'pmid': '24937541', 'type': 'DERIVED', 'citation': 'Straznicky NE, Grima MT, Sari CI, Eikelis N, Lambert GW, Nestel PJ, Karapanagiotidis S, Wong C, Richards K, Marusic P, Dixon JB, Schlaich MP, Lambert EA. A randomized controlled trial of the effects of pioglitazone treatment on sympathetic nervous system activity and cardiovascular function in obese subjects with metabolic syndrome. J Clin Endocrinol Metab. 2014 Sep;99(9):E1701-7. doi: 10.1210/jc.2014-1976. Epub 2014 Jun 17.'}]}, 'descriptionModule': {'briefSummary': "An abdominal distribution of fat is associated with the greatest heart disease risk, because commonly, several risk factors of metabolic origin cluster in these individuals. When this occurs the condition is called the 'metabolic syndrome'.\n\nIncreased activity of the sympathetic nervous system resulting in enhanced release of the stress hormone 'noradrenaline', may be one mechanism by which adverse cardiovascular and metabolic sequela of the metabolic syndrome might be mediated. Impaired insulin action may be one factor contributing to increased noradrenaline release.\n\nThe aim of this Study is to determine whether treatment with a drug called pioglitazone which is known to improve insulin action, results in reduced sympathetic nervous system activity and stress hormone release when compared to treatment with a dummy drug (placebo).", 'detailedDescription': 'The rapidly growing burden of obesity together with a population that is becoming older raises the importance of effective strategies for the primary prevention and treatment of the metabolic syndrome in order to combat the epidemic of type 2 diabetes and to reduce the increased risk of cardiovascular mortality.\n\nIncreased sympathetic nervous system activity may participate in the pathogenesis and complications of the metabolic syndrome. This Study will use a randomised controlled design to evaluate the effects of pioglitazone treatment on sympathetic activity in middle-aged subjects with the metabolic syndrome.The results will generate new information on the neuroadrenergic effects of thiazolidinediones in this clinical setting. This is relevant to the understanding of the pathophysiology of the metabolic syndrome and to its clinical management.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '65 Years', 'minimumAge': '45 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Males and females aged 45-65 years,\n* non-smokers,\n* HOMA index \\> 2.5 and\n* who meet ATP III criteria for the metabolic syndrome\n\nExclusion Criteria:\n\n* History of diabetes,\n* previous MI, stroke, heart failure, impaired hepatic or renal function.\n* Inability to cease medications which may affect study parameters.'}, 'identificationModule': {'nctId': 'NCT00408850', 'briefTitle': 'Effects of Pioglitazone Treatment on Sympathetic Nervous System Function in Metabolic Syndrome Obesity', 'organization': {'class': 'OTHER', 'fullName': 'Baker Heart Research Institute'}, 'officialTitle': 'Mechanisms of Sympathetic Overactivity in the Metabolic Syndrome: Effects of Reversing Insulin Resistance by Drug Treatment', 'orgStudyIdInfo': {'id': 'G 06M 2610'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'ACTIVE_COMPARATOR', 'label': 'Pioglitazone', 'description': 'pioglitazone 15 mg for 6 weeks followed by 30 mg for 6 weeks', 'interventionNames': ['Drug: Pioglitazone']}, {'type': 'PLACEBO_COMPARATOR', 'label': 'sugar pill', 'description': 'Placebo comparator', 'interventionNames': ['Drug: sugar pill']}], 'interventions': [{'name': 'Pioglitazone', 'type': 'DRUG', 'otherNames': ['Actos'], 'description': '15 mg per day for 6 weeks and 30 mg per day for further 6 weeks', 'armGroupLabels': ['Pioglitazone']}, {'name': 'sugar pill', 'type': 'DRUG', 'otherNames': ['Lactose'], 'description': 'One capsule daily for 6 weeks followed by two capsules per day for next 6 weeks', 'armGroupLabels': ['sugar pill']}]}, 'contactsLocationsModule': {'locations': [{'zip': '8008', 'city': 'Melbourne', 'state': 'Victoria', 'status': 'RECRUITING', 'country': 'Australia', 'contacts': [{'name': 'Nora E Straznicky, PhD MPH', 'role': 'PRINCIPAL_INVESTIGATOR'}], 'facility': 'Baker Heart Research Institute', 'geoPoint': {'lat': -37.814, 'lon': 144.96332}}], 'centralContacts': [{'name': 'Nora E Straznicky, PhD, MPH', 'role': 'CONTACT', 'email': 'Nora.Straznicky@bakeridi.edu.au', 'phone': '61 3 8532 1371'}], 'overallOfficials': [{'name': 'Nora E Straznicky, PhD, MPH', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Baker Heart Research Institute'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Baker Heart Research Institute', 'class': 'OTHER'}, 'collaborators': [{'name': 'National Heart Foundation, Australia', 'class': 'OTHER'}], 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Dr', 'investigatorFullName': 'Nora E. Straznicky', 'investigatorAffiliation': 'Baker Heart Research Institute'}}}}