Ignite Creation Date:
2025-12-25 @ 4:12 AM
Ignite Modification Date:
2025-12-26 @ 3:10 AM
Study NCT ID:
NCT05728320
Status:
RECRUITING
Last Update Posted:
2024-04-16
First Post:
2023-01-03
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Glycemic Patterns After Bariatric Surgery and High Glycemic Variability and Hypoglycemia Unawareness Risk Factors
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D007003', 'term': 'Hypoglycemia'}], 'ancestors': [{'id': 'D044882', 'term': 'Glucose Metabolism Disorders'}, {'id': 'D008659', 'term': 'Metabolic Diseases'}, {'id': 'D009750', 'term': 'Nutritional and Metabolic Diseases'}]}}, 'protocolSection': {'designModule': {'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'CROSS_SECTIONAL', 'observationalModel': 'CASE_CONTROL'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 200}, 'patientRegistry': False}, 'statusModule': {'overallStatus': 'RECRUITING', 'startDateStruct': {'date': '2022-03-01', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2024-04', 'completionDateStruct': {'date': '2026-03-01', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2024-04-14', 'studyFirstSubmitDate': '2023-01-03', 'studyFirstSubmitQcDate': '2023-02-11', 'lastUpdatePostDateStruct': {'date': '2024-04-16', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2023-02-15', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2025-09-01', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'High glucose variability', 'timeFrame': '14 days', 'description': 'Interstitial blood glucose'}, {'measure': 'Unawareness hypoglycemia', 'timeFrame': '14 days', 'description': 'Interstitial blood glucose'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['Hypoglycemia', 'Cognition', 'Glycemic variability', 'Bariatric surgery'], 'conditions': ['Bariatric Surgery']}, 'descriptionModule': {'briefSummary': 'To study the glycemic patterns of patients undergoing bariatric surgery and what are the risk factors capable of predicting episodes of unnoticed hypoglycemia and high glycemic variability, evaluating patients who underwent reduction gastroplasty with Roux-en-Y reconstruction (GRYR) and sleeve gastrectomy (SG)', 'detailedDescription': 'To study the glycemic patterns of patients undergoing bariatric surgery and what are the risk factors capable of predicting episodes of unnoticed hypoglycemia and high glycemic variability, evaluating patients who underwent reduction gastroplasty with Roux-en-Y reconstruction (GRYR) and sleeve gastrectomy (SG). Methods: Patients of both sexes, aged 18-60 years, submitted to GRYR and SG, for at least one year, under medical follow-up at the Multiuser Clinical Research Center (CePeM). Patients using hypoglycemic drugs (biguanides, sulfonylureas, glinides, acarbose, GLP-1 analogues, SGLT-2 inhibitors, DPP-IV inhibitors and insulin) and hyperglycemic drugs (corticosteroids, high-dose thiazide diuretics, beta-blockers, diazoxide and octreotide), very restrictive diets (intermittent fasting or ketogenic diet), pregnant women, kidney, heart and/or liver failure, history of neurological disorder, visual or hearing impairment, being treated for alcohol or drug abuse, severe psychiatric disorders (schizophrenia, bipolar disorder), vitamin B12 deficiency, iron deficiency anemia, patients with neurodegenerative diseases of the brain or retina or cerebrovascular diseases and those who do not agree to sign the informed consent form. Eligible patients will undergo a medical consultation, which will consist of anamnesis and physical examination and will wear a flash glucose monitor, model Freestyle Libre by Abbott, which should be used for a period of 7 to 14 days. They will complete the Three Factor Eating Questionnaire R21 (TFEQ-R21), International Physical Activity Questionnaire (IPAQ), Gold Questionnaire, Edinburgh Hypoglycemia Symptom Scale (EHSS), Rey Auditory Verbal Learning Test (RAVLT), Beck Depression Inventory (BDI), Beck Anxiety Inventory (BAI), Trail Making Test (TMT) and Stroop Test. Will be evaluated as possible predictive factors the time elapsed from surgery, surgical technique, excess weight loss, rate of weight regain, previous diabetes mellitus, age, sex, resting heart rate, history of cholecystectomy, laboratory values of glycated hemoglobin, fasting glycemia, lipidogram and renal, thyroid and hepatic functions.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT'], 'maximumAge': '60 Years', 'minimumAge': '18 Years', 'samplingMethod': 'NON_PROBABILITY_SAMPLE', 'studyPopulation': 'Patients submitted to GRYR and SG, for at least one year and control subjects not submitted to bariatric surgery', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Patients submitted to GRYR and SG, for at least one year, undergoing medical follow-up at the Multiuser Clinical Research Center (CePeM) of the Pedro Ernesto University Hospital (HUPE).\n\nExclusion Criteria:\n\n* patients using hypoglycemic drugs (biguanides, sulfonylureas, glinides, acarbose, GLP-1 analogues, SGLT-2 inhibitors, DPP-IV inhibitors and insulin) and hyperglycemic drugs (corticosteroids, high-dose thiazide diuretics, beta-blockers, diazoxide and octreotide) , very restrictive diets (intermittent fasting or ketogenic diet), pregnant women, kidney, heart and/or liver failure, history of neurological disorder, visual or hearing impairment, being treated for alcohol or drug abuse, severe psychiatric disorders (schizophrenia, bipolar disorder ), vitamin B12 deficiency, iron deficiency anemia, patients with neurodegenerative diseases of the brain or retina or cerebrovascular diseases and those who do not agree to sign the informed consent form'}, 'identificationModule': {'nctId': 'NCT05728320', 'briefTitle': 'Glycemic Patterns After Bariatric Surgery and High Glycemic Variability and Hypoglycemia Unawareness Risk Factors', 'organization': {'class': 'OTHER', 'fullName': 'Rio de Janeiro State University'}, 'officialTitle': 'Analysis of Glycemic Patterns of Patients Undergoing Bariatric Surgery and Assessment of Risk Factors Capable of Predicting High Glycemic Variability and Unnoticed Hypoglycemia', 'orgStudyIdInfo': {'id': 'Bariglivar'}}, 'armsInterventionsModule': {'armGroups': [{'label': 'Gastric bypass', 'description': 'Subjects submitted to gastric bypass', 'interventionNames': ['Device: Glucose monitoring with flash glucose monitor']}, {'label': 'Sleeve gastrectomy', 'description': 'Subjects submitted to sleeve gastrectomy', 'interventionNames': ['Device: Glucose monitoring with flash glucose monitor']}, {'label': 'Normal control subjects', 'description': 'Subjects not submitted to bariatric surgery with IMC \\< 25', 'interventionNames': ['Device: Glucose monitoring with flash glucose monitor']}, {'label': 'Obese control subjects', 'description': 'Subjects not submitted to bariatric surgery with IMC \\> 30', 'interventionNames': ['Device: Glucose monitoring with flash glucose monitor']}], 'interventions': [{'name': 'Glucose monitoring with flash glucose monitor', 'type': 'DEVICE', 'description': 'All groups will be monitorized with a flash glucose monitor and compared after 7-14 days.', 'armGroupLabels': ['Gastric bypass', 'Normal control subjects', 'Obese control subjects', 'Sleeve gastrectomy']}]}, 'contactsLocationsModule': {'locations': [{'zip': '20550013', 'city': 'Rio de Janeiro', 'status': 'RECRUITING', 'country': 'Brazil', 'contacts': [{'name': 'Luiz Guilherme K de Aguiar, PhD', 'role': 'CONTACT', 'email': 'lgkraemeraguiar@gmail.com', 'phone': '+55(21)23340703'}, {'name': 'Karynne G Lisboa Lopes dos Santos, PhD', 'role': 'CONTACT', 'email': 'kjgolrj@gmail.com', 'phone': '(+5521) 23340703'}, {'name': 'Daniel S da Silva, Graduate', 'role': 'SUB_INVESTIGATOR'}, {'name': 'Karynne G Lisboa Lopes dos Santos, PhD', 'role': 'SUB_INVESTIGATOR'}, {'name': 'Luiz Guilherme K de Aguiar, PhD', 'role': 'PRINCIPAL_INVESTIGATOR'}], 'facility': 'Laboratory for Clinical and Experimental Research on Vascular Biology', 'geoPoint': {'lat': -22.90642, 'lon': -43.18223}}]}, 'ipdSharingStatementModule': {'ipdSharing': 'UNDECIDED'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Rio de Janeiro State University', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Principal Investigator', 'investigatorFullName': 'Luiz Guilherme Kraemer-Aguiar, MD', 'investigatorAffiliation': 'Rio de Janeiro State University'}}}}