Ignite Creation Date:
2025-12-24 @ 11:49 PM
Ignite Modification Date:
2026-02-25 @ 8:17 PM
Study NCT ID:
NCT04439851
Status:
COMPLETED
Last Update Posted:
2020-06-19
First Post:
2020-06-10
Is Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Impact of Sleeve Gastrectomy on Monocyte-to-High-Density Lipoprotein Cholesterol Ratio
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D009765', 'term': 'Obesity'}], 'ancestors': [{'id': 'D050177', 'term': 'Overweight'}, {'id': 'D044343', 'term': 'Overnutrition'}, {'id': 'D009748', 'term': 'Nutrition Disorders'}, {'id': 'D009750', 'term': 'Nutritional and Metabolic Diseases'}, {'id': 'D001835', 'term': 'Body Weight'}, {'id': 'D012816', 'term': 'Signs and Symptoms'}, {'id': 'D013568', 'term': 'Pathological Conditions, Signs and Symptoms'}]}}, 'protocolSection': {'designModule': {'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'PROSPECTIVE', 'observationalModel': 'COHORT'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 125}, 'patientRegistry': False}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2017-01-01', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2020-06', 'completionDateStruct': {'date': '2017-12-31', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2020-06-17', 'studyFirstSubmitDate': '2020-06-10', 'studyFirstSubmitQcDate': '2020-06-17', 'lastUpdatePostDateStruct': {'date': '2020-06-19', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2020-06-19', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2017-12-31', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Monocyte-to-High-Density Lipoprotein Cholesterol Ratio changes', 'timeFrame': '6 months', 'description': 'Monocyte-to-High-Density Lipoprotein Cholesterol Ratio changes after Sleeve Gastrectomy'}]}, 'oversightModule': {'oversightHasDmc': True, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Laparoscopic Sleeve Gastrectomy', 'Cardiovascular Risk Factor', 'Obesity']}, 'descriptionModule': {'briefSummary': 'The present study hypothesized that significant weight loss is associated with a reduction in the inflammatory markers, leading to diminished cardiovascular risks in patients undergoing laparoscopic sleeve gastrectomy (LGS).\n\nWe found a decrease in MHR at postoperative 6 months from baseline in patients undergoing LSG. The decrease in MHR was more remarkable with increasing percentage of EWL, but no relationship between the %EWL and MHR.', 'detailedDescription': 'The present study aims to evaluate the relationship between MHR, metabolic parameters and the percentage of excess weight loss (%EWL) in participants undergoing laparoscopic sleeve gastrectomy (LSG).\n\nThis prospective cohort study will evaluate obese participants undergoing LSG. Demographic data of the participants and blood glucose level, monocyte count and lipid parameters baseline and at 6 months after surgery will record. The MHR baseline and at 6 months after surgery and the %EWL at 6 months after surgery will calculate. The participants will be divide into two groups as participants with %EWL of \\<50 and patients with a %EWL of ≥50. The parameters will compare between the two groups.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'samplingMethod': 'NON_PROBABILITY_SAMPLE', 'studyPopulation': 'Obese patients (BMI ≥40 or \\>35+ and accompanying DM, HT and hyperlipidemia)', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\nObese patients (BMI ≥40 or \\>35+ and accompanying DM, HT and hyperlipidemia) Underwent laparoscopic sleeve gastrectomy.\n\nExclusion Criteria:\n\nReceiving antihyperlipidemic therapy, Important complications that continue within 6 months after surgery (anastomotic leaks, pulmonary embolism, deep vein thrombosis, soft tissue infection) Did not attend 6-month control visit were excluded from the study.'}, 'identificationModule': {'nctId': 'NCT04439851', 'briefTitle': 'Impact of Sleeve Gastrectomy on Monocyte-to-High-Density Lipoprotein Cholesterol Ratio', 'organization': {'class': 'OTHER_GOV', 'fullName': 'Umraniye Education and Research Hospital'}, 'officialTitle': 'The Relationship Between Monocyte-to-High-Density Lipoprotein Cholesterol Ratio, Metabolic Parameters and Excess Weight Loss in Patients Undergoing Laparoscopic Sleeve Gastrectomy', 'orgStudyIdInfo': {'id': 'umraniye training hospital'}}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Umraniye Education and Research Hospital', 'class': 'OTHER_GOV'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Principal Investigator', 'investigatorFullName': 'Sibel Ocak Serin', 'investigatorAffiliation': 'Umraniye Education and Research Hospital'}}}}