Ignite Creation Date:
2025-12-25 @ 12:54 AM
Ignite Modification Date:
2026-01-01 @ 8:25 AM
Study NCT ID:
NCT05235867
Status:
RECRUITING
Last Update Posted:
2024-03-08
First Post:
2022-02-01
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Secretin in Refeeding
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}}, 'protocolSection': {'designModule': {'bioSpec': {'retention': 'SAMPLES_WITHOUT_DNA', 'description': 'serum and urine'}, 'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'PROSPECTIVE', 'observationalModel': 'CASE_CONTROL'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 10}, 'patientRegistry': False}, 'statusModule': {'overallStatus': 'RECRUITING', 'startDateStruct': {'date': '2022-02-01', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2024-03', 'completionDateStruct': {'date': '2024-12-31', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2024-03-06', 'studyFirstSubmitDate': '2022-02-01', 'studyFirstSubmitQcDate': '2022-02-01', 'lastUpdatePostDateStruct': {'date': '2024-03-08', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2022-02-11', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2024-06-30', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Change in secretin', 'timeFrame': '1 hour', 'description': 'Change in secretin value from pre- to post- meal'}], 'secondaryOutcomes': [{'measure': 'Change in serum bicarbonate', 'timeFrame': '1 hour', 'description': 'Change in bicarbonate value from pre- to post- meal'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Anorexia in Adolescence']}, 'descriptionModule': {'briefSummary': "Patients with restrictive-type anorexia nervosa who are admitted to the hospital for feeding often urinate excessive amounts. Others have changes in the way that they handle acid and base. These issues prolong hospitalizations. Current data suggest that one hormone--named secretin--may control both urine output and how the body handles acid and base. This study will evaluate whether secretin levels are different in anorexic patients who urinate an excessive amount compared to those who urinate normal amounts. For this study, patients will have one extra blood draw before and after one meal during their hospitalization. The blood draw before the meal coincides with a standard of care blood draw. Also after the meal, subjects will be asked to provide one extra urine sample. Information from subject's medical records will also be used."}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['CHILD', 'ADULT'], 'maximumAge': '24 Years', 'minimumAge': '13 Years', 'samplingMethod': 'NON_PROBABILITY_SAMPLE', 'studyPopulation': 'Adolescents with restrictive-type anorexia hospitalized for medical nutritional stabilization.', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Group 1:\n\n * male and female patients\n * age 13-24 years\n * diagnosis of restrictive-type anorexia nervosa\n * hospitalization for nutritional support\n * \\>4 cc/kg/day of urine output (a.k.a. "fluid dumpers"; n=5)\n* Group 2:\n\n * male and female patients\n * age 13-24 years\n * diagnosis of restrictive-type anorexia nervosa\n * hospitalization for nutritional support\n * \\<2 cc/kg/d of urine output (a.k.a. "non-dumpers"; n=5)\n\nExclusion Criteria:\n\n* 5150 hold\n* Anti-depressant, anti-psychotic, or anticonvulsant medications\n* Previous hospitalization within the past 6 months\n* Underlying metabolic disorder not related to anorexia nervosa (including chronic kidney disease, renal tubular disorders, and underlying endocrine disorders)\n* Pregnancy\n* NG or G-tube feeds after day 2 of hospitalization\n* \\> 10% of nutritional needs from supplemental feeds'}, 'identificationModule': {'nctId': 'NCT05235867', 'briefTitle': 'Secretin in Refeeding', 'organization': {'class': 'OTHER', 'fullName': 'University of California, Los Angeles'}, 'officialTitle': 'Secretin Levels in Refeeding-induced Polyuria (Cross Section)', 'orgStudyIdInfo': {'id': 'IRB#21-001489'}}, 'armsInterventionsModule': {'armGroups': [{'label': 'dumpers', 'description': '* male and female patients\n* age 13-24 years\n* diagnosis of restrictive-type anorexia nervosa\n* hospitalization for nutritional support\n* \\>4 cc/kg/day of urine output (a.k.a. "fluid dumpers"; n=5)'}, {'label': 'non-dumpers', 'description': '* male and female patients\n* age 13-24 years\n* diagnosis of restrictive-type anorexia nervosa\n* hospitalization for nutritional support\n* \\<2 cc/kg/d of urine output (a.k.a. "non-dumpers"; n=5)'}]}, 'contactsLocationsModule': {'locations': [{'zip': '90095', 'city': 'Los Angeles', 'state': 'California', 'status': 'RECRUITING', 'country': 'United States', 'contacts': [{'name': 'Finnegan Mercer', 'role': 'CONTACT', 'email': 'fjmercer@mednet.ucla.edu', 'phone': '310-206-7631'}], 'facility': 'University of California, Los Angeles (UCLA)', 'geoPoint': {'lat': 34.05223, 'lon': -118.24368}}], 'centralContacts': [{'name': 'Misciel Macaraig', 'role': 'CONTACT', 'email': 'mbmacaraig@mednet.ucla.edu', 'phone': '310-825-0922'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'University of California, Los Angeles', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Principal Investigator', 'investigatorFullName': 'Elaine L. Rosen, MD', 'investigatorAffiliation': 'University of California, Los Angeles'}}}}