Ignite Creation Date:
2025-12-25 @ 5:19 AM
Ignite Modification Date:
2025-12-26 @ 4:27 AM
Study NCT ID:
NCT01007227
Status:
COMPLETED
Last Update Posted:
2013-09-26
First Post:
2009-11-02
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Metabolic Syndrome and Fingertip Endothelial Dysfunction
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'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'NON_RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'SINGLE_GROUP'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 70}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2006-08'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2013-09', 'completionDateStruct': {'date': '2011-12', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2013-09-25', 'studyFirstSubmitDate': '2009-11-02', 'studyFirstSubmitQcDate': '2009-11-02', 'lastUpdatePostDateStruct': {'date': '2013-09-26', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2009-11-03', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2011-12', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Endothelial function assessed by RH-PAT', 'timeFrame': 'About 1 year later'}], 'secondaryOutcomes': [{'measure': 'Metabolic status including waist circumference', 'timeFrame': 'About 1 year later'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'conditions': ['Metabolic Syndrome']}, 'descriptionModule': {'briefSummary': 'Life-style intervention with dietetic and exercise therapy is an important fundamental approach to patients with metabolic syndrome (MetSyd) which may cause endothelial dysfunction leading to cardiovascular events. We investigated whether the life-style modification by dietetic and exercise instruction could improve endothelial dysfunction assessed by a new non-invasive and automatic device; digital reactive hyperemia peripheral arterial tonometry (RH-PAT).', 'detailedDescription': 'Outline of methods RH-PAT was measured in high-risk patients under 70 years old. The MetSyd was defined according to guidelines of the National Cholesterol Education Program Third Adult Treatment Panel (NCEP - ATP III). We instructed all MetSyd patients about the dietetic and exercise therapy according to the Japan Atherosclerosis Society Guidelines for Prevention of Atherosclerotic Cardiovascular Diseases. we conducted a questionnaire survey of the self-assessment for dietetic and exercise instruction program, respectively.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '90 Years', 'minimumAge': '20 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Under 70 years old and preserved left ventricular systolic function (left ventricular ejection fraction ≥ 50%)\n\nExclusion Criteria:\n\n* Severe valvular heart disease\n* Atrial septal defect\n* Myocarditis\n* Cardiomyopathy\n* Active inflammatory diseases\n* Pulmonary hypertension\n* Chronic kidney disease on hemodialysis\n* Advanced hepatic disease\n* Leukemia\n* Schizophrenia; AND\n* Cerebrovascular disease and residual hemiplegia.'}, 'identificationModule': {'nctId': 'NCT01007227', 'briefTitle': 'Metabolic Syndrome and Fingertip Endothelial Dysfunction', 'organization': {'class': 'OTHER', 'fullName': 'Kumamoto University'}, 'officialTitle': 'Achievement of Dietetic and Exercise Therapy Evaluated by Self-assessment Score Significantly Improved Endothelial Dysfunction in Patients With Metabolic Syndrome', 'orgStudyIdInfo': {'id': '743EndothelialMetsyd'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'OTHER', 'label': 'Lifestyle instruction', 'interventionNames': ['Other: Lifestyle instruction']}], 'interventions': [{'name': 'Lifestyle instruction', 'type': 'OTHER', 'description': 'Instruction dietetic and exercise therapy', 'armGroupLabels': ['Lifestyle instruction']}]}, 'contactsLocationsModule': {'locations': [{'zip': '860-8556', 'city': 'Kumamoto', 'state': 'Kumamoto', 'country': 'Japan', 'facility': 'Kumamoto University Hospital', 'geoPoint': {'lat': 32.80589, 'lon': 130.69181}}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Kumamoto University', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'MD, PhD', 'investigatorFullName': 'Seigo Sugiyama', 'investigatorAffiliation': 'Kumamoto University'}}}}