Ignite Creation Date:
2025-12-24 @ 5:38 PM
Ignite Modification Date:
2026-01-01 @ 11:15 PM
Study NCT ID:
NCT03338868
Status:
UNKNOWN
Last Update Posted:
2017-11-17
First Post:
2017-11-07
Is Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Serum Concentrations, Physical and Psychological Well-being in Metabolic Syndrome
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D024821', 'term': 'Metabolic Syndrome'}, {'id': 'D009043', 'term': 'Motor Activity'}, {'id': 'D010146', 'term': 'Pain'}], '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'}, {'id': 'D001519', 'term': 'Behavior'}, {'id': 'D009461', 'term': 'Neurologic Manifestations'}, {'id': 'D012816', 'term': 'Signs and Symptoms'}, {'id': 'D013568', 'term': 'Pathological Conditions, Signs and Symptoms'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D001823', 'term': 'Body Composition'}, {'id': 'D011788', 'term': 'Quality of Life'}, {'id': 'D008603', 'term': 'Mental Health'}, {'id': 'D006403', 'term': 'Hematologic Tests'}], 'ancestors': [{'id': 'D001669', 'term': 'Biochemical Phenomena'}, {'id': 'D055598', 'term': 'Chemical Phenomena'}, {'id': 'D008660', 'term': 'Metabolism'}, {'id': 'D001824', 'term': 'Body Constitution'}, {'id': 'D010829', 'term': 'Physiological Phenomena'}, {'id': 'D006304', 'term': 'Health Status'}, {'id': 'D003710', 'term': 'Demography'}, {'id': 'D015991', 'term': 'Epidemiologic Measurements'}, {'id': 'D011634', 'term': 'Public Health'}, {'id': 'D004778', 'term': 'Environment and Public Health'}, {'id': 'D006262', 'term': 'Health'}, {'id': 'D011154', 'term': 'Population Characteristics'}, {'id': 'D019411', 'term': 'Clinical Laboratory Techniques'}, {'id': 'D019937', 'term': 'Diagnostic Techniques and Procedures'}, {'id': 'D003933', 'term': 'Diagnosis'}, {'id': 'D008919', 'term': 'Investigative Techniques'}]}}, 'protocolSection': {'designModule': {'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'PROSPECTIVE', 'observationalModel': 'CASE_CONTROL'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 100}, 'targetDuration': '2 Days', 'patientRegistry': True}, 'statusModule': {'overallStatus': 'UNKNOWN', 'lastKnownStatus': 'RECRUITING', 'startDateStruct': {'date': '2015-08-01', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2017-11', 'completionDateStruct': {'date': '2017-12-30', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2017-11-10', 'studyFirstSubmitDate': '2017-11-07', 'studyFirstSubmitQcDate': '2017-11-08', 'lastUpdatePostDateStruct': {'date': '2017-11-17', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2017-11-09', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2017-11-30', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Blood tests', 'timeFrame': '2 years', 'description': 'for uric acid levels.'}], 'secondaryOutcomes': [{'measure': 'Body composition', 'timeFrame': '2 years', 'description': 'evaluated by Bodystat®1500 Bio-impedance Analyzer'}, {'measure': 'Physical activity level', 'timeFrame': '2 years', 'description': 'assessed by the International Physical Activity Questionnaire-7. The intensity of self-reported physical activity, lasting at ten minutes per bout, was used to assess metabolic equivalent (MET). The MET is defined as the ratio of a working metabolic rate to a standard resting metabolic rate.MET-minutes/week was computed by multiplying the MET score of an activity (3.3 for walking, 4.0 for moderate-intensity, and 8.0 for vigorous-intensity) by the minutes and days performed. The summation of walking, moderate, and vigorous METs-minutes/week enabled the computation of the total physical activity performed by an individual.'}, {'measure': 'The musculoskeletal pain intensity', 'timeFrame': '2 years', 'description': 'evaluated with 0 to 10 cm Visual Analog Scale. "0" indicated "no pain" and the "10" indicated "the worst imaginable pain".'}, {'measure': 'Quality of life', 'timeFrame': '2 years', 'description': 'evaluated with the Nottingham Health Profile (NHP). It contains 38 items divided into 6 dimensions: NHP-energy, NHP-pain, NHP-emotional reactions, NHP sleep, NHP-social isolation, and NHP-physical mobility. All the parameters are summed as NHP-total. The respondent answers "yes" if the statement adequately reflected the current status or feeling, or "no" otherwise. Dimension scores ranged from 0 (no problems) to 100 (maximum problems).'}, {'measure': 'Psychological Well-Being (Anxiety and Deppression condition)', 'timeFrame': '2 years', 'description': 'evaluated with the Hospital Anxiety and Depression Scale (HADS). Each question was scored on a 4-point Likert scale, ranging from 0 to 3, where a higher score represented more severe anxiety or depression.'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['physical activity', 'pain', 'uric acid'], 'conditions': ['Metabolic Syndrome']}, 'referencesModule': {'references': [{'pmid': '15067822', 'type': 'RESULT', 'citation': 'Afzal N, Mahmud TE, Jahan SS, Kundi S. Uric acid profile in patients with chronic nonspecific musculoskeletal pain. J Ayub Med Coll Abbottabad. 2003 Oct-Dec;15(4):5-9.'}, {'pmid': '28244715', 'type': 'RESULT', 'citation': 'Fu YQ, Yang H, Zheng JS, Zeng XY, Zeng W, Fan ZF, Chen M, Wang L, Li D. Positive association between metabolic syndrome and serum uric acid in Wuhan. Asia Pac J Clin Nutr. 2017 Mar;26(2):343-350. doi: 10.6133/apjcn.012016.06.'}, {'pmid': '23665093', 'type': 'RESULT', 'citation': 'Chu AH, Moy FM. Association between physical activity and metabolic syndrome among Malay adults in a developing country, Malaysia. J Sci Med Sport. 2014 Mar;17(2):195-200. doi: 10.1016/j.jsams.2013.04.003. Epub 2013 May 9.'}, {'pmid': '27901223', 'type': 'RESULT', 'citation': 'Saboya PP, Bodanese LC, Zimmermann PR, Gustavo AD, Assumpcao CM, Londero F. Metabolic syndrome and quality of life: a systematic review. Rev Lat Am Enfermagem. 2016 Nov 28;24:e2848. doi: 10.1590/1518-8345.1573.2848.'}, {'pmid': '19839027', 'type': 'RESULT', 'citation': 'Takeuchi T, Nakao M, Nomura K, Inoue M, Tsurugano S, Shinozaki Y, Yano E. Association of the metabolic syndrome with depression and anxiety in Japanese men: a 1-year cohort study. Diabetes Metab Res Rev. 2009 Nov;25(8):762-7. doi: 10.1002/dmrr.1041.'}]}, 'descriptionModule': {'briefSummary': 'The purpose of this study was to investigate the serum concentrations, physical and psychological well-being characteristics in patients having chronic musculoskeletal pain with metabolic syndrome, and to compare patients without metabolic syndrome.', 'detailedDescription': 'Metabolic syndrome (MetS) is a combination of metabolic risk factors such as impaired glucose level, dyslipidemia, hypertension, and central obesity. MetS has become a large public health issue with common interrelation to different accompanying disorders. Moreover, the link between MetS and musculoskeletal disorders has previously been demonstrated.\n\nPresence and prevalence of MetS in patients having musculoskeletal pain seems common and interrelated.However, to our knowledge, manifestations with clinical symptoms of MetS, some inflammatory markers via serum concentrations and physical and psychological health profiles of patients with seeking treatment from outpatient physical therapy for musculoskeletal pain conditions have not been researched up to now.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '70 Years', 'minimumAge': '20 Years', 'samplingMethod': 'PROBABILITY_SAMPLE', 'studyPopulation': 'patients having chronic musculoskeletal pain with and without metabolic syndrome', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\nTo be a volunteer patient with a chronic non-specific musculoskeletal pain disorder, including knee osteoarthritis, rotator cuff tear, adhesive capsulitis, and non-specific low back, back or neck pain for more than 6 months.\n\nExclusion Criteria:\n\nthe presence of severe physical disability, psychiatric disorder, malignant tumors, pregnancy, chronic alcohol consumption, gout, heart failure, liver and renal dysfunction.'}, 'identificationModule': {'nctId': 'NCT03338868', 'briefTitle': 'Serum Concentrations, Physical and Psychological Well-being in Metabolic Syndrome', 'organization': {'class': 'OTHER', 'fullName': 'Ataturk Training and Research Hospital'}, 'officialTitle': 'Comparison of Serum Concentrations, Physical and Psychological Well-being in Patients Having Chronic Musculoskeletal Pain With and Without Metabolic Syndrome', 'orgStudyIdInfo': {'id': '2015-13/32'}}, 'armsInterventionsModule': {'armGroups': [{'label': 'Patients with MetS', 'description': 'To be a volunteer patient with a chronic non-specific musculoskeletal pain disorder, including knee osteoarthritis, rotator cuff tear, adhesive capsulitis, and non-specific low back, back or neck pain for more than 6 months.', 'interventionNames': ['Other: Body composition', 'Other: Physical activity level', 'Other: Musculoskeletal pain intensity', 'Other: Quality of life', 'Other: Psychological Well-Being', 'Diagnostic Test: Blood tests']}, {'label': 'Patients without MetS', 'description': 'To be a volunteer patient with a chronic non-specific musculoskeletal pain disorder, including knee osteoarthritis, rotator cuff tear, adhesive capsulitis, and non-specific low back, back or neck pain for more than 6 months.', 'interventionNames': ['Other: Body composition', 'Other: Physical activity level', 'Other: Musculoskeletal pain intensity', 'Other: Quality of life', 'Other: Psychological Well-Being', 'Diagnostic Test: Blood tests']}], 'interventions': [{'name': 'Body composition', 'type': 'OTHER', 'description': 'evaluated by Bodystat®1500 Bio-impedance Analyzer', 'armGroupLabels': ['Patients with MetS', 'Patients without MetS']}, {'name': 'Physical activity level', 'type': 'OTHER', 'description': 'assessed by the International Physical Activity Questionnaire-7', 'armGroupLabels': ['Patients with MetS', 'Patients without MetS']}, {'name': 'Musculoskeletal pain intensity', 'type': 'OTHER', 'description': 'evaluated with Visual Analog Scale', 'armGroupLabels': ['Patients with MetS', 'Patients without MetS']}, {'name': 'Quality of life', 'type': 'OTHER', 'description': 'assessed by the Nottingham Health Profile', 'armGroupLabels': ['Patients with MetS', 'Patients without MetS']}, {'name': 'Psychological Well-Being', 'type': 'OTHER', 'description': 'assessed by the Hospital Anxiety and Depression Scale', 'armGroupLabels': ['Patients with MetS', 'Patients without MetS']}, {'name': 'Blood tests', 'type': 'DIAGNOSTIC_TEST', 'description': 'Blood tests included serum glucose, triglyceride, high-density lipoprotein cholesterol (HDL-C), and uric acid levels. Blood samples were collected from the patients after one night of fasting.', 'armGroupLabels': ['Patients with MetS', 'Patients without MetS']}]}, 'contactsLocationsModule': {'locations': [{'zip': '06800', 'city': 'Ankara', 'state': 'Cankaya', 'status': 'ACTIVE_NOT_RECRUITING', 'country': 'Turkey (Türkiye)', 'facility': 'Ataturk Training and Research Hospital', 'geoPoint': {'lat': 39.91987, 'lon': 32.85427}}, {'zip': '06800', 'city': 'Ankara', 'state': 'Cankaya', 'status': 'RECRUITING', 'country': 'Turkey (Türkiye)', 'contacts': [{'name': 'Seyda Toprak Celenay, Assist Prof', 'role': 'CONTACT', 'email': 'sydtoprak@hotmail.com', 'phone': '+90 530 041 39 86'}], 'facility': 'Ataturk Training and Research Hospital', 'geoPoint': {'lat': 39.91987, 'lon': 32.85427}}], 'centralContacts': [{'name': 'Seyda Toprak Celenay, Asist Prof', 'role': 'CONTACT', 'email': 'sydtoprak@hotmail.com', 'phone': '+90 530 041 3986'}], 'overallOfficials': [{'name': 'Seyda Toprak Celenay, Assist prof', 'role': 'STUDY_DIRECTOR', 'affiliation': 'Ankara Yildirim Beyazit University Ataturk Training and Research Hospital'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'UNDECIDED'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Ataturk Training and Research Hospital', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Assistant Professor, PT, PhD', 'investigatorFullName': 'Seyda TOPRAK CELENAY', 'investigatorAffiliation': 'Ataturk Training and Research Hospital'}}}}