Ignite Creation Date:
2025-12-24 @ 10:40 PM
Ignite Modification Date:
2025-12-25 @ 8:11 PM
Study NCT ID:
NCT00956735
Status:
COMPLETED
Last Update Posted:
2013-12-16
First Post:
2009-08-10
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Effects of Pistachios on Cardiovascular Responses to Stress in Type 2 Diabetes
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D002318', 'term': 'Cardiovascular Diseases'}, {'id': 'D003924', 'term': 'Diabetes Mellitus, Type 2'}], 'ancestors': [{'id': 'D003920', 'term': 'Diabetes Mellitus'}, {'id': 'D044882', 'term': 'Glucose Metabolism Disorders'}, {'id': 'D008659', 'term': 'Metabolic Diseases'}, {'id': 'D009750', 'term': 'Nutritional and Metabolic Diseases'}, {'id': 'D004700', 'term': 'Endocrine System Diseases'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'SINGLE', 'whoMasked': ['OUTCOMES_ASSESSOR']}, 'primaryPurpose': 'BASIC_SCIENCE', 'interventionModel': 'CROSSOVER'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 30}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2009-08'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2013-12', 'completionDateStruct': {'date': '2013-03', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2013-12-13', 'studyFirstSubmitDate': '2009-08-10', 'studyFirstSubmitQcDate': '2009-08-10', 'lastUpdatePostDateStruct': {'date': '2013-12-16', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2009-08-11', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2013-03', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Cardiovascular responses to stress', 'timeFrame': 'End of each diet period'}, {'measure': 'Insulin sensitivity and resistance', 'timeFrame': 'End of each diet period'}, {'measure': 'Lipids and lipoproteins', 'timeFrame': 'End of each diet period'}], 'secondaryOutcomes': [{'measure': 'Vascular endothelial function', 'timeFrame': 'End of each diet period'}, {'measure': 'Mood and perceived stress', 'timeFrame': 'End of each diet period'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'keywords': ['Cardiovascular Disease', 'Type II Diabetes', 'Nutrition', 'Pistachios', 'Cardiovascular disease risk factors in adults with Type II diabetes'], 'conditions': ['Cardiovascular Disease', 'Type 2 Diabetes']}, 'referencesModule': {'references': [{'pmid': '18779280', 'type': 'BACKGROUND', 'citation': 'Gebauer SK, West SG, Kay CD, Alaupovic P, Bagshaw D, Kris-Etherton PM. Effects of pistachios on cardiovascular disease risk factors and potential mechanisms of action: a dose-response study. Am J Clin Nutr. 2008 Sep;88(3):651-9. doi: 10.1093/ajcn/88.3.651.'}, {'pmid': '25815738', 'type': 'DERIVED', 'citation': 'Sauder KA, Pokorney PE, McCrea CE, Ulbrecht JS, Kris-Etherton PM, West SG. Noninvasive assessment of hemodynamics: a comparative analysis of fingertip pulse contour analysis and impedance cardiography. Blood Press Monit. 2015 Aug;20(4):209-14. doi: 10.1097/MBP.0000000000000118.'}, {'pmid': '24980134', 'type': 'DERIVED', 'citation': 'Sauder KA, McCrea CE, Ulbrecht JS, Kris-Etherton PM, West SG. Pistachio nut consumption modifies systemic hemodynamics, increases heart rate variability, and reduces ambulatory blood pressure in well-controlled type 2 diabetes: a randomized trial. J Am Heart Assoc. 2014 Jun 30;3(4):e000873. doi: 10.1161/JAHA.114.000873.'}], 'seeAlsoLinks': [{'url': 'http://bbh.hhdev.psu.edu/lab/WestLab/index.html', 'label': 'Vascular Health Interventions Lab, Penn State University'}]}, 'descriptionModule': {'briefSummary': 'This study is investigating the effects of three different diets, including a diet with pistachios, on cardiovascular disease risk markers in people with type 2 diabetes.', 'detailedDescription': 'The study will last 12-16 weeks and requires 10-13 visits to the General Clinical Research Center on the University Park campus. All food and snacks will be provided for 10 weeks. At the end of each of three diet periods, participants will undergo a test of endothelial function, an oral glucose tolerance test, and a cardiovascular stress reactivity test.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '75 Years', 'minimumAge': '30 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Healthy, nonsmoking adults, aged 30-75 years (women must be post-menopausal)\n* Diagnosed with Type 2 diabetes\n\nExclusion Criteria:\n\n* Insulin, more than one blood pressure lowering medication, daily aspirin, NSAID therapy, oral steroids within the last 6 weeks, oral contraceptives, and hormone replacement therapy\n* Chronic disease such as cardiovascular disease or any complications of diabetes (retinopathy, neuropathy, etc).\n* Allergies or aversions to pistachios\n* Unwillingness to consume all foods provided and no other meals or snacks for the 10 weeks of diet intervention'}, 'identificationModule': {'nctId': 'NCT00956735', 'acronym': 'Pistachio', 'briefTitle': 'Effects of Pistachios on Cardiovascular Responses to Stress in Type 2 Diabetes', 'organization': {'class': 'OTHER', 'fullName': 'Penn State University'}, 'officialTitle': 'Effects of Pistachios on Cardiovascular Responses to Stress in Type 2 Diabetes: A Novel Intervention for a High Risk Population', 'orgStudyIdInfo': {'id': '29970'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Pistachio Diet', 'description': 'Incorporates 3.0 oz (2 servings) of pistachios into a daily diet', 'interventionNames': ['Other: Pistachio']}, {'type': 'NO_INTERVENTION', 'label': 'Non-Pistachio', 'description': 'Does not incorporate pistachios into a daily diet'}], 'interventions': [{'name': 'Pistachio', 'type': 'OTHER', 'description': '3.0 oz (2 servings) of roasted and salted or unsalted pistachios', 'armGroupLabels': ['Pistachio Diet']}]}, 'contactsLocationsModule': {'locations': [{'zip': '16802-6501', 'city': 'University Park', 'state': 'Pennsylvania', 'country': 'United States', 'facility': 'Penn State University - General Clinical Research Center', 'geoPoint': {'lat': 40.80201, 'lon': -77.85639}}], 'overallOfficials': [{'name': 'Sheila G. West, PhD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Penn State University'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Penn State University', 'class': 'OTHER'}, 'collaborators': [{'name': 'American Pistachio Growers', 'class': 'OTHER'}], 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Associate Professor', 'investigatorFullName': 'Sheila G West', 'investigatorAffiliation': 'Penn State University'}}}}