Ignite Creation Date:
2025-12-24 @ 5:56 PM
Ignite Modification Date:
2025-12-25 @ 3:20 PM
Study NCT ID:
NCT03930368
Status:
UNKNOWN
Last Update Posted:
2019-04-29
First Post:
2019-04-16
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Application of Raw Corn Starch on Patients With Insulinoma
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D044903', 'term': 'Congenital Hyperinsulinism'}, {'id': 'D007340', 'term': 'Insulinoma'}], 'ancestors': [{'id': 'D010182', 'term': 'Pancreatic Diseases'}, {'id': 'D004066', 'term': 'Digestive System Diseases'}, {'id': 'D007232', 'term': 'Infant, Newborn, Diseases'}, {'id': 'D009358', 'term': 'Congenital, Hereditary, and Neonatal Diseases and Abnormalities'}, {'id': 'D006946', 'term': 'Hyperinsulinism'}, {'id': 'D044882', 'term': 'Glucose Metabolism Disorders'}, {'id': 'D008659', 'term': 'Metabolic Diseases'}, {'id': 'D009750', 'term': 'Nutritional and Metabolic Diseases'}, {'id': 'D007003', 'term': 'Hypoglycemia'}, {'id': 'D007516', 'term': 'Adenoma, Islet Cell'}, {'id': 'D000236', 'term': 'Adenoma'}, {'id': 'D009375', 'term': 'Neoplasms, Glandular and Epithelial'}, {'id': 'D009370', 'term': 'Neoplasms by Histologic Type'}, {'id': 'D009369', 'term': 'Neoplasms'}, {'id': 'D010190', 'term': 'Pancreatic Neoplasms'}, {'id': 'D004067', 'term': 'Digestive System Neoplasms'}, {'id': 'D009371', 'term': 'Neoplasms by Site'}, {'id': 'D004701', 'term': 'Endocrine Gland Neoplasms'}, {'id': 'D004700', 'term': 'Endocrine System Diseases'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'NA', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'SINGLE_GROUP', 'interventionModelDescription': 'In vie of the fact that insulinoma is a rare disease and it will be difficult to enroll enough cases in this study, a prospective single-arm before-and-after study will be performed.'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 20}}, 'statusModule': {'overallStatus': 'UNKNOWN', 'lastKnownStatus': 'RECRUITING', 'startDateStruct': {'date': '2019-04-15', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2019-04', 'completionDateStruct': {'date': '2019-12', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2019-04-24', 'studyFirstSubmitDate': '2019-04-16', 'studyFirstSubmitQcDate': '2019-04-24', 'lastUpdatePostDateStruct': {'date': '2019-04-29', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2019-04-29', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2019-12', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'the change of fasting blood glucose', 'timeFrame': 'from initiation of nutritional intervention to 2 weeks later, or by the time of curative surgery', 'description': 'the change of mean fasting blood glucose before and after nutritional intervention'}, {'measure': 'the change of requency of hypoglycemia onset', 'timeFrame': 'from initiation of nutritional intervention to 2 weeks later, or by the time of curative surgery', 'description': 'the change of requency of hypoglycemia onset before and after nutritional intervention'}, {'measure': 'the change of glycated albumin', 'timeFrame': 'from initiation of nutritional intervention to 2 weeks later, or by the time of curative surgery', 'description': 'the change of glycated albumin before and after nutritional intervention'}], 'secondaryOutcomes': [{'measure': 'the change of satiety score', 'timeFrame': 'from initiation of nutritional intervention to 2 weeks later, or by the time of curative surgery', 'description': 'the change of self-reported satiety score before and after nutritional intervention. Satiety will be measured using a graphic rating scale that combined verbal descriptors on a scale graded 0-6 (0 = no sensation, 1 = just noticeable/threshold, 2 = very mild, 3 = mild, 4 = moderate, 5 = fullness, 6 = pain)'}, {'measure': 'the change of weight / BMI', 'timeFrame': 'from initiation of nutritional intervention to 2 weeks later, or by the time of curative surgery', 'description': 'the change of weight / BMI before and after nutritional intervention'}, {'measure': 'the change of body fat mass (rate of fat mass) before and after nutritional intervention', 'timeFrame': 'from initiation of nutritional intervention to 2 weeks later, or by the time of curative surgery', 'description': 'the change of body fat mass (rate of fat mass) before and after nutritional intervention, through measurement by bioelectrical impedence analysis'}, {'measure': 'the change of lipid profile (level of total triglycerides, total cholesterol, LDL-C, HDL-C, free fatty acid ) before and after nutritional intervention', 'timeFrame': 'from initiation of nutritional intervention to 2 weeks later, or by the time of curative surgery', 'description': 'the change of total triglycerides, total cholesterol, LDL-C, HDL-C and free fatty acid befor and after nutritional intervention, through measurement by lipid profiles'}, {'measure': 'the change of uric acid', 'timeFrame': 'from initiation of nutritional intervention to 2 weeks later, or by the time of curative surgery', 'description': 'the change of uric acid before and after nutritional intervention'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Hyperinsulinemic Hypoglycemia', 'Insulinoma', 'Raw Corn Starch']}, 'descriptionModule': {'briefSummary': 'This will be a prospective single-arm before-and-after clinical trial in which raw corn starch (RCS) will be first applied on patients with unoperated insulinoma. Nutritional intervention with supplementation of RCS will be initiated in 20 patients with suspected insulinoma to improve their hypoglycemia before the surgery. Duration of nutritional intervention, fasting blood glucose, lipid profile, weight change, BMI and other metabolic indices will be recorded and compared before and after the intervention.', 'detailedDescription': "Insulinoma is a rare disease which can cause recurrent hyperinsulinemic hypoglycemia, subsequent hyperphagia as well as weight gain. As only 50% \\~ 60% of pharmacological therapy (diazoxide, somatostatin, etc) is effective to elevate blood glucose, the nutritional interventions play a role as an important supportive treatment to maintain glycemic stablization and control weight gain before the curative surgery. As the essential management for patients with glycogen storage disease (GSD), the extended release cornstarch has been proved superior to prevent hypoglycemia since 1980s. Its application has elevated GSD patients' quality of life and prolonged their survival. In view of its charicteristic of chronic release in gastrointestinal tract, we will for the first time try to utilize the raw corn starch (RCS) on patients with suspected insulinoma and evaluate its efficacy of improving hypoglycemia in such patients.\n\nThis will be a prospective single-arm before-and-after clinical trial. Nutritional intervention with supplementation of RCS will be initiated in 20 patients with suspected insulinoma to improve their hypoglycemia before the surgery. Duration of nutritional intervention, fasting blood glucose, lipid profile, weight change, BMI and other metabolic indices will be recorded and compared before and after the intervention."}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* having recurrent symptoms of hypoglycemia (blood glucose less than 2.8 mmol/L) which could be relieved by intake of glucose, which condition accords with typical Whipple triad.\n* being proved to have abnormally increased secretion of endogeneous insulin at onset of hypoglycemia.\n* diagnosis of insulinoma is highly suspected, in view of clinical presentation, laboratory tests and imaging examinations.\n\nExclusion Criteria:\n\n* severe gastrointestinal dysfunction with intolerance of raw corn starch'}, 'identificationModule': {'nctId': 'NCT03930368', 'briefTitle': 'Application of Raw Corn Starch on Patients With Insulinoma', 'organization': {'class': 'OTHER', 'fullName': 'Peking Union Medical College Hospital'}, 'officialTitle': 'Application of Raw Corn Starch on Patients With Unoperated Insulinoma is Helpful to Decrease Risk of Hypoglycemia', 'orgStudyIdInfo': {'id': 'RCS-insulinoma'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Intervened arm', 'description': 'as in a single-arm before-and after study, the only one arm will receive intervention of low GI diet with supplementation of RCS.', 'interventionNames': ['Other: low GI diet with regular supplementation of raw corn starch']}], 'interventions': [{'name': 'low GI diet with regular supplementation of raw corn starch', 'type': 'OTHER', 'description': 'Patients will be guided with a low GI diet with 60%\\~70% of energy from carbohydrates. RCS constituted 30%\\~50% of daily carbohydrate, and was supplemented as snacks every 4\\~6 hours (25g per time) especially at night.', 'armGroupLabels': ['Intervened arm']}]}, 'contactsLocationsModule': {'locations': [{'zip': '100730', 'city': 'Beijing', 'status': 'RECRUITING', 'country': 'China', 'contacts': [{'name': 'Rongrong Li', 'role': 'CONTACT', 'email': 'lirongrong0331@163.com', 'phone': '+8601069155550'}], 'facility': 'Peking Union Medical College Hospital', 'geoPoint': {'lat': 39.9075, 'lon': 116.39723}}], 'centralContacts': [{'name': 'Rongrong Li', 'role': 'CONTACT', 'email': 'lirongrong0331@163.com', 'phone': '+8601069155550'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Peking Union Medical College Hospital', 'class': 'OTHER'}, 'responsibleParty': {'type': 'SPONSOR'}}}}