Ignite Creation Date:
2025-12-24 @ 11:56 PM
Ignite Modification Date:
2025-12-25 @ 9:52 PM
Study NCT ID:
NCT05997251
Status:
COMPLETED
Last Update Posted:
2023-08-18
First Post:
2023-08-10
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
The Relationship of DASH and Mediterranean Diet Score With Serum Adiponectin Levels in Patients With Spinal Cord Injury
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D013119', 'term': 'Spinal Cord Injuries'}], 'ancestors': [{'id': 'D013118', 'term': 'Spinal Cord Diseases'}, {'id': 'D002493', 'term': 'Central Nervous System Diseases'}, {'id': 'D009422', 'term': 'Nervous System Diseases'}, {'id': 'D020196', 'term': 'Trauma, Nervous System'}, {'id': 'D014947', 'term': 'Wounds and Injuries'}]}}, 'protocolSection': {'designModule': {'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'CROSS_SECTIONAL', 'observationalModel': 'CASE_CONTROL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 66}, 'patientRegistry': False}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2021-03-01', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2023-08', 'completionDateStruct': {'date': '2022-03-01', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2023-08-10', 'studyFirstSubmitDate': '2023-08-10', 'studyFirstSubmitQcDate': '2023-08-10', 'lastUpdatePostDateStruct': {'date': '2023-08-18', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2023-08-18', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2022-03-01', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Adiponectin level', 'timeFrame': 'Will be measured at inclusion', 'description': 'Adiponectin level will be measured from peripheral blood'}, {'measure': 'DASH diet score', 'timeFrame': 'Will be measured at inclusion from one day dietary record', 'description': 'Will be measured at inclusion from one day dietary record'}, {'measure': 'Mediterrenian diet score', 'timeFrame': 'Will be measured at inclusion from one day dietary record', 'description': 'Will be measured at inclusion from one day dietary record'}], 'secondaryOutcomes': [{'measure': 'Whole blood count', 'timeFrame': 'Will be measured at inclusion', 'description': 'Will be measured at inclusion'}, {'measure': 'Fasting blood glucose', 'timeFrame': 'Will be measured at inclusion', 'description': 'Will be measured at inclusion'}, {'measure': 'Total cholesterol', 'timeFrame': 'Will be measured at inclusion', 'description': 'Will be measured at inclusion'}, {'measure': 'LDL', 'timeFrame': 'Will be measured at inclusion', 'description': 'Will be measured at inclusion'}, {'measure': 'HDL', 'timeFrame': 'Will be measured at inclusion', 'description': 'Will be measured at inclusion'}, {'measure': 'TG', 'timeFrame': 'Will be measured at inclusion', 'description': 'Will be measured at inclusion'}]}, 'oversightModule': {'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['Adiponectin'], 'conditions': ['Spinal Cord Injuries']}, 'referencesModule': {'references': [{'pmid': '16213239', 'type': 'BACKGROUND', 'citation': 'Wang YH, Huang TS, Liang HW, Su TC, Chen SY, Wang TD. Fasting serum levels of adiponectin, ghrelin, and leptin in men with spinal cord injury. Arch Phys Med Rehabil. 2005 Oct;86(10):1964-8. doi: 10.1016/j.apmr.2005.04.017.'}, {'pmid': '16708117', 'type': 'BACKGROUND', 'citation': 'Ekmekci H, Ekmekci OB. The role of adiponectin in atherosclerosis and thrombosis. Clin Appl Thromb Hemost. 2006 Apr;12(2):163-8. doi: 10.1177/107602960601200203.'}, {'pmid': '29559683', 'type': 'BACKGROUND', 'citation': "O'Brien LC, Graham ZA, Chen Q, Lesnefsky EJ, Cardozo C, Gorgey AS. Plasma adiponectin levels are correlated with body composition, metabolic profiles, and mitochondrial markers in individuals with chronic spinal cord injury. Spinal Cord. 2018 Sep;56(9):863-872. doi: 10.1038/s41393-018-0089-8. Epub 2018 Mar 20."}]}, 'descriptionModule': {'briefSummary': 'The aim of this study is to reveal the relationship of DASH and Mediterranean diet score with anthropometric measurements and serum adiponectin level in individuals with spinal cord injury. This research was planned as a cross-sectional, case-control study. With the data to be obtained from the research, information will be obtained about the hormonal or biochemical basis of metabolic disorders such as atherosclerosis and insulin resistance that may occur in individuals with spinal cord injury in the long term.\n\n20 individuals with Spinal Cord Injury will be included in the study, and the results of the patients will be compared with 20 healthy individuals. In order to determine the food consumption status of the patients, a 1-day food consumption record will be requested. DASH diet score and Mediterranean diet score will be calculated from dietary records. After 8 hours of fasting, 3 ml of peripheral blood will be taken for the measurement of adiponectin between 08:00 and 09:00 in the morning from the individuals in the study and control groups. Adiponectin level will be measured and its correlation with DASH diet score and Mediterranean diet score will be examined.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '65 Years', 'minimumAge': '18 Years', 'samplingMethod': 'PROBABILITY_SAMPLE', 'studyPopulation': 'Patients admitted to hospital Healthy population from patient care givers of hospital staff', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Inclusion criteria (Study group)\n\n * Having spent at least 6 months after spinal cord injury\n * 1st motor neuron injury\n * Being between the ages of 18-65\n * Giving consent to participate in the study Inclusion criteria (Control group)\n * Being between the ages of 18-65\n * Giving consent to participate in the study\n\nExclusion Criteria:\n\n* Exclusion criteria (Study group)\n\n * Having an additional disease to the spinal cord injury\n * Having a 2nd motor neuron lesion\n\nExclusion criteria (Control group)\n\n• Having any disease'}, 'identificationModule': {'nctId': 'NCT05997251', 'briefTitle': 'The Relationship of DASH and Mediterranean Diet Score With Serum Adiponectin Levels in Patients With Spinal Cord Injury', 'organization': {'class': 'OTHER', 'fullName': 'Ankara City Hospital Bilkent'}, 'officialTitle': 'The Relationship of DASH and Mediterranean Diet Score With Serum Adiponectin Levels in Patients With Spinal Cord Injury', 'orgStudyIdInfo': {'id': 'E2-21-89'}}, 'armsInterventionsModule': {'armGroups': [{'label': 'Patients with spinal cord injury', 'interventionNames': ['Other: Keeping a 1-day food consumption record by the patient', 'Other: Measurement of adiponectin level']}, {'label': 'Healthy group', 'interventionNames': ['Other: Keeping a 1-day food consumption record by the patient', 'Other: Measurement of adiponectin level']}], 'interventions': [{'name': 'Keeping a 1-day food consumption record by the patient', 'type': 'OTHER', 'description': 'Checking and receiving the 1-day food consumption record recorded by the patient by the researcher', 'armGroupLabels': ['Healthy group', 'Patients with spinal cord injury']}, {'name': 'Measurement of adiponectin level', 'type': 'OTHER', 'description': 'Adiponectin level will be measured for each group', 'armGroupLabels': ['Healthy group', 'Patients with spinal cord injury']}]}, 'contactsLocationsModule': {'locations': [{'city': 'Ankara', 'country': 'Turkey (Türkiye)', 'facility': 'Ankara Bilkent City Hospital Physical Treatment and Rehabilitation Hospital', 'geoPoint': {'lat': 39.91987, 'lon': 32.85427}}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Ankara City Hospital Bilkent', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'MD', 'investigatorFullName': 'Emre Adıgüzel', 'investigatorAffiliation': 'Ankara City Hospital Bilkent'}}}}