Ignite Creation Date:
2025-12-25 @ 3:41 AM
Ignite Modification Date:
2025-12-26 @ 2:27 AM
Study NCT ID:
NCT07209202
Status:
NOT_YET_RECRUITING
Last Update Posted:
2025-10-06
First Post:
2025-09-30
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Fructose Intestinal Gluconeogenesis
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'TRIPLE', 'whoMasked': ['PARTICIPANT', 'INVESTIGATOR', 'OUTCOMES_ASSESSOR']}, 'primaryPurpose': 'BASIC_SCIENCE', 'interventionModel': 'CROSSOVER'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 40}}, 'statusModule': {'overallStatus': 'NOT_YET_RECRUITING', 'startDateStruct': {'date': '2025-12', 'type': 'ESTIMATED'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2025-09', 'completionDateStruct': {'date': '2030-06', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2025-09-30', 'studyFirstSubmitDate': '2025-09-30', 'studyFirstSubmitQcDate': '2025-09-30', 'lastUpdatePostDateStruct': {'date': '2025-10-06', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2025-10-06', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2030-06', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Fru-GNG', 'timeFrame': '6 hours', 'description': 'Total amount of fructose converted to glucose'}, {'measure': 'Fru-hGNG', 'timeFrame': '6 hours', 'description': 'Amount of fructose converted to glucose in the liver'}, {'measure': 'Fru-iGNG', 'timeFrame': '6 hours', 'description': 'Amount of fructose converted to glucose in the intestine'}, {'measure': 'De novo lipogenesis (DNL)', 'timeFrame': '6 hours', 'description': 'Percent of newly synthesized palmitate'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['Fructose', 'Sugar'], 'conditions': ['Healthy Participants', 'Obese But Otherwise Healthy Participants']}, 'descriptionModule': {'briefSummary': 'This study will test the hypothesis that within a defined range of fructose intake, the ability to convert fructose to glucose (via gluconeogenesis) in the small intestine plays a protective role for the liver, shielding it from the deleterious effects of fructose. We will investigate whether this protective effect of the intestine is impaired in individuals with obesity.', 'detailedDescription': 'Qualified participants will undergo a sugar tolerance test at baseline and then randomized to undergo four separate outpatient tracer/feeding studies in a crossover fashion. After an overnight fast, a six-hour fed tracer study will be initiated, during which participants will consume liquid meals containing stable isotopes at regular intervals and receive other isotopes intravenously. Meal composition will differ only by fructose content (High vs. Low) and tracer (oral vs. intravenous 13C-labeled fructose). Blood and urine samples will be collected frequently throughout the study. Each visit will be performed approximately three weeks apart. Vital signs and anthropometrics will be measured at each clinic visit.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT'], 'maximumAge': '55 Years', 'minimumAge': '20 Years', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* BMI 30 to 38 kg/m2 (obese group) or BMI 19 to 25 kg/m2 (lean group)\n\nExclusion Criteria:\n\n* Pregnancy or lactation within the past six months;\n* Type 1 or 2 diabetes mellitus (including fasting glucose ≥126 mg/dL, HgbA1c ≥6.5%);\n* History of liver disease or AST and ALT 2x above the upper limit of normal;\n* Fasting triglyceride \\> 300 mg/dl; total cholesterol levels above the 95th percentile for age and sex;\n* Hemoglobin (Hgb) \\<12.5g/d or hematocrit\\<3x Hgb value;\n* Report of HIV or hepatitis B or C infection;\n* History of cancer, other than basal cell or squamous cell carcinoma or kidney disease stage 3 or higher or patients currently on dialysis;\n* Use of any anti-diabetic medications or hypolipidemic agents in the past six months;\n* History of surgical procedure for obesity;\n* Change in body weight \\>5% in the past six months (by self-report);\n* History of other conditions known to affect insulin sensitivity and lipid metabolism (e.g., polycystic ovary syndrome), history of galactosemia, hereditary fructose intolerance, or who test positive for fructose malabsorption at screening;\n* Known intolerance to acetaminophen.'}, 'identificationModule': {'nctId': 'NCT07209202', 'acronym': 'FIG', 'briefTitle': 'Fructose Intestinal Gluconeogenesis', 'organization': {'class': 'OTHER', 'fullName': 'Touro University, California'}, 'officialTitle': 'Fructose Metabolism Effects on the Liver: Unraveling the Role of Defective Intestinal GNG in Individuals With Obesity', 'orgStudyIdInfo': {'id': 'M-2624'}, 'secondaryIdInfos': [{'id': 'R01DK140477', 'link': 'https://reporter.nih.gov/quickSearch/R01DK140477', 'type': 'NIH'}]}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'High fructose meals, oral 13C fructose', 'description': 'Liquid meals will be fed, containing 55% total carbohydrate (16% fructose), 30% fat, 15% protein, and a tracer amount of 13C fructose.', 'interventionNames': ['Other: High fructose meal', 'Other: 13C labeled fructose, oral']}, {'type': 'EXPERIMENTAL', 'label': 'High Fructose Meals, IV 13C Fructose', 'description': 'Liquid meals will be fed, containing 55% total carbohydrate (16% fructose), 30% fat, 15% protein. A tracer amount of 13C fructose will be administered intravenously.', 'interventionNames': ['Other: High fructose meal', 'Other: 13C labeled fructose, intravenous']}, {'type': 'EXPERIMENTAL', 'label': 'Low fructose meals, oral fructose tracer', 'description': 'Liquid meals will be fed, containing 55% total carbohydrate (6% fructose), 30% fat, 15% protein, and a tracer amount of 13C fructose.', 'interventionNames': ['Other: Low fructose meal', 'Other: 13C labeled fructose, oral']}, {'type': 'EXPERIMENTAL', 'label': 'Low fructose meals, IV 13C fructose tracer', 'description': 'Liquid meals will be fed, containing 55% total carbohydrate (6% fructose), 30% fat, 15% protein. A tracer amount of 13C fructose will be administered intravenously.', 'interventionNames': ['Other: Low fructose meal', 'Other: 13C labeled fructose, intravenous']}], 'interventions': [{'name': 'High fructose meal', 'type': 'OTHER', 'description': 'Liquid meals containing 55% total carbohydrate (16% fructose), 30% fat, 15% protein.', 'armGroupLabels': ['High Fructose Meals, IV 13C Fructose', 'High fructose meals, oral 13C fructose']}, {'name': 'Low fructose meal', 'type': 'OTHER', 'description': '55% total carbohydrate (6% fructose), 30% fat, 15% protein.', 'armGroupLabels': ['Low fructose meals, IV 13C fructose tracer', 'Low fructose meals, oral fructose tracer']}, {'name': '13C labeled fructose, oral', 'type': 'OTHER', 'description': 'Tracer amount of 13C labeled fructose administered orally in the meals.', 'armGroupLabels': ['High fructose meals, oral 13C fructose', 'Low fructose meals, oral fructose tracer']}, {'name': '13C labeled fructose, intravenous', 'type': 'OTHER', 'description': 'Tracer amount of 13C fructose administered intravenously', 'armGroupLabels': ['High Fructose Meals, IV 13C Fructose', 'Low fructose meals, IV 13C fructose tracer']}]}, 'contactsLocationsModule': {'centralContacts': [{'name': 'Sally Chiu, PhD', 'role': 'CONTACT', 'email': 'schiu2@touro.edu', 'phone': '707-638-5404'}, {'name': 'Lisa Johnson, RN', 'role': 'CONTACT', 'email': 'ljohnson19@touro.edu'}], 'overallOfficials': [{'name': 'Jean-Marc Schwarz, PhD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Touro University, California'}, {'name': 'Grace M Jones, PhD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Touro University, California'}]}, 'ipdSharingStatementModule': {'infoTypes': ['STUDY_PROTOCOL', 'SAP', 'ICF'], 'timeFrame': 'Study data will be made available for at least 5 years from publication of the primary manuscript.', 'ipdSharing': 'YES', 'description': 'The de-identified clinical and laboratory data set will be made available upon request to academic investigators.', 'accessCriteria': 'Academic investigators may request data and supporting information upon request to the PI.'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Touro University, California', 'class': 'OTHER'}, 'collaborators': [{'name': 'National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)', 'class': 'NIH'}], 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Professor', 'investigatorFullName': 'Jean-marc Schwarz', 'investigatorAffiliation': 'Touro University, California'}}}}