Ignite Creation Date:
2025-12-24 @ 12:08 PM
Ignite Modification Date:
2026-01-11 @ 4:57 AM
Study NCT ID:
NCT03821961
Status:
UNKNOWN
Last Update Posted:
2020-02-26
First Post:
2019-01-22
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
18F-FDOPA PET/CT Imaging in Patients Undergoing Metabolic Surgery
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D003924', 'term': 'Diabetes Mellitus, Type 2'}, {'id': 'D011236', 'term': 'Prediabetic State'}, {'id': 'D009765', 'term': 'Obesity'}], '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'}, {'id': 'D050177', 'term': 'Overweight'}, {'id': 'D044343', 'term': 'Overnutrition'}, {'id': 'D009748', 'term': 'Nutrition Disorders'}, {'id': 'D001835', 'term': 'Body Weight'}, {'id': 'D012816', 'term': 'Signs and Symptoms'}, {'id': 'D013568', 'term': 'Pathological Conditions, Signs and Symptoms'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D050110', 'term': 'Bariatric Surgery'}], 'ancestors': [{'id': 'D049088', 'term': 'Bariatrics'}, {'id': 'D000073319', 'term': 'Obesity Management'}, {'id': 'D013812', 'term': 'Therapeutics'}, {'id': 'D013514', 'term': 'Surgical Procedures, Operative'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'NA', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'SINGLE_GROUP'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 30}}, 'statusModule': {'overallStatus': 'UNKNOWN', 'lastKnownStatus': 'RECRUITING', 'startDateStruct': {'date': '2018-09-03', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2020-02', 'completionDateStruct': {'date': '2020-12-31', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2020-02-23', 'studyFirstSubmitDate': '2019-01-22', 'studyFirstSubmitQcDate': '2019-01-26', 'lastUpdatePostDateStruct': {'date': '2020-02-26', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2019-01-30', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2020-11-30', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Change in Uptake value of 18F-FDOPA PET/CT from baseline', 'timeFrame': '6 months', 'description': 'Standardized Uptake Value'}], 'secondaryOutcomes': [{'measure': 'Change in Glycated Hemoglobin from baseline', 'timeFrame': '6 months', 'description': 'percent change'}, {'measure': 'Change in Fasting Plasma Glucose from baseline', 'timeFrame': '6 months', 'description': 'percent change'}, {'measure': 'Changes in c-peptide level from baseline', 'timeFrame': '6 months', 'description': 'percent change'}, {'measure': 'Changes in Insulinogenic index from baseline', 'timeFrame': '6 months', 'description': '(insulin30 min - insulinfasting)/(glucose30 min - glucosefasting)'}, {'measure': 'Changes in HOMA-IR(homeostatic model assessment for insulin resistance) from baseline', 'timeFrame': '6 months', 'description': '(insulinfasting × glucosefasting)/405'}, {'measure': 'Changes in Matsuda index from baseline', 'timeFrame': '6 months', 'description': 'Insulin sensitivity indices obtained from oral glucose tolerance testing (Diabetes Care 22:1462-1470, 1999)'}, {'measure': 'Change in Body Mass Index (BMI) from baseline', 'timeFrame': '6 months', 'description': 'percent change'}, {'measure': 'Change in Systolic Blood Pressure from baseline', 'timeFrame': '6 months', 'description': 'percent change'}, {'measure': 'Change in serum level of HDL cholesterol from baseline', 'timeFrame': '6 months', 'description': 'percent change'}, {'measure': 'Change in serum level of Triglycerides from baseline', 'timeFrame': '6 months', 'description': 'percent change'}, {'measure': 'Change in serum level of LDL cholesterol from baseline', 'timeFrame': '6 months', 'description': 'percent change'}, {'measure': 'Change in serum level of Total Cholesterol from baseline', 'timeFrame': '6 months', 'description': 'percent change'}, {'measure': 'Change in serum level of High-sensitivity C-reactive Protein', 'timeFrame': '6 months', 'description': 'percent change'}, {'measure': 'Change in number of diabetes medication from baseline', 'timeFrame': '6 months', 'description': 'number of medication'}, {'measure': 'Change in dosage of diabetes medication from baseline', 'timeFrame': '6 months', 'description': 'Dosage of medication'}, {'measure': 'Change in number of hypertension medication from baseline', 'timeFrame': '6 months', 'description': 'number of medication'}, {'measure': 'Change in dosage of hypertension medication from baseline', 'timeFrame': '6 months', 'description': 'Dosage of medication'}, {'measure': 'Change in number of dyslipidemia medication from baseline', 'timeFrame': '6 months', 'description': 'number of medication'}, {'measure': 'Change in dosage of dyslipidemia medication from baseline', 'timeFrame': '6 months', 'description': 'Dosage of medication'}, {'measure': 'Change in serum level of amino acid metabolites from baseline', 'timeFrame': '6 months', 'description': 'glucose homeostasis and energy expenditure related metabolites'}, {'measure': 'Change in BDI scores of questionnaire from baseline', 'timeFrame': '6 months', 'description': 'Beck Depression Inventory(Score range, 0-68)(Higer values represent a worse outcome)'}, {'measure': 'Change in HDRS scores of questionnaire from baseline', 'timeFrame': '6 months', 'description': 'Hamilton Depression Rating Scale(Score range, 0-54)(Higer values represent a worse outcome)'}, {'measure': 'Change in SF-36 scores of questionnaire from baseline', 'timeFrame': '6 months', 'description': '36 Item Short Form Survery(Scale for quality of life)(Higer values represent a worse outcome) (Score range for physical health, 0-400) (Score range for mental health, 0-400)'}, {'measure': 'Change in IWQOL scores of questionnaire from baseline', 'timeFrame': '6 months', 'description': 'Impact of Weight on Quality of Life(Score range, 31-155)(Higer values represent a worse outcome)'}, {'measure': 'Change in MAQOL scores of questionnaire from baseline', 'timeFrame': '6 months', 'description': 'Moorehead-Ardelt Quality of Life(Score range, -3 to 3)(Higer values represent a better outcome)'}]}, 'oversightModule': {'oversightHasDmc': True, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['Diabetes Mellitus, Type 2', 'PreDiabetes', 'Obesity'], 'conditions': ['Diabetes Mellitus, Type 2', 'PreDiabetes', 'Obesity']}, 'descriptionModule': {'briefSummary': 'The aim of the study is to compare the endocrine function of pancreas between pre and post metabolic surgery in patients with type 2 diabetes or prediabetes. The study will examine the endocrine function of pancreas using 18F-FDOPA PET/CT imaging and various biochemical laboratory tests'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '19 Years', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Type 2 diabetes or prediabetes\n* Body mass index \\>25.0 kg/m2\n* Written informed consent\n\nExclusion Criteria:\n\n* Diabetes induced by chronic pancreatitis or pancreas cancer\n* Chronic glucocorticoid usage\n* Significant coronary artery disease or cerebrovascular disease within the previous 3 months\n* Uncompensated congestive heart failure\n* Severe pulmonary disease defined as FEV1 \\< 50% of predicted value\n* End stage renal disease on dialysis\n* Acute infectious disease within the previous 3 months\n* Pulmonary thromboembolism or thrombophlebitis within the previous 3 months\n* History of cancer (except for basal cell skin cancer or cancer in situ)\n* Prior gastrointestinal surgery (except for appendectomy or hemorrhoidectomy)\n* Gastrointestinal disorders, malabsorptive disorders, or inflammatory bowel disease\n* History of chronic liver disease (except for NAFLD/NASH)\n* Psychiatric disorders including dementia, active psychosis, severe depression requiring \\> 2 medications, history of suicide attempts, alcohol or drug abuse within the previous 5 years'}, 'identificationModule': {'nctId': 'NCT03821961', 'briefTitle': '18F-FDOPA PET/CT Imaging in Patients Undergoing Metabolic Surgery', 'organization': {'class': 'OTHER', 'fullName': 'Korea University Anam Hospital'}, 'officialTitle': 'The Effect of Metabolic Surgery on the Endocrine Function of Pancreas: Clinical Value of 18F-FDOPA PET/CT Imaging', 'orgStudyIdInfo': {'id': 'STARDOM-PET'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Metabolic surgery', 'description': 'Roux-en-Y gastric bypass, Sleeve gastrectomy', 'interventionNames': ['Procedure: Metabolic Surgery']}], 'interventions': [{'name': 'Metabolic Surgery', 'type': 'PROCEDURE', 'description': 'Roux-en-Y gastric bypass, Sleeve gastrectomy', 'armGroupLabels': ['Metabolic surgery']}]}, 'contactsLocationsModule': {'locations': [{'zip': '02841', 'city': 'Seoul', 'status': 'RECRUITING', 'country': 'South Korea', 'contacts': [{'name': 'Yeongkeun Kwon, MD, PhD', 'role': 'CONTACT', 'email': 'kukwon@korea.ac.kr', 'phone': '+82 2 920 5027'}], 'facility': 'Korea University Anam Hospital', 'geoPoint': {'lat': 37.566, 'lon': 126.9784}}], 'centralContacts': [{'name': 'Yeongkeun Kwon, MD, PhD', 'role': 'CONTACT', 'email': 'kukwon@korea.ac.kr', 'phone': '+82 2 920 5027'}], 'overallOfficials': [{'name': 'Sungsoo Park, MD, PhD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Korea University Anam Hospital'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Korea University Anam Hospital', 'class': 'OTHER'}, 'collaborators': [{'name': 'Myungmoon Pharma. Co. Ltd.', 'class': 'INDUSTRY'}], 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Professor', 'investigatorFullName': 'Sungsoo Park', 'investigatorAffiliation': 'Korea University Anam Hospital'}}}}