Ignite Creation Date:
2025-12-24 @ 11:10 PM
Ignite Modification Date:
2025-12-25 @ 8:43 PM
Study NCT ID:
NCT06338969
Status:
RECRUITING
Last Update Posted:
2024-04-03
First Post:
2024-03-24
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
The Impact of Different Carbohydrate Restriction After a Gastric Bypass on the Ketosis and Ketoacidosis
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D009767', 'term': 'Obesity, Morbid'}, {'id': 'D007662', 'term': 'Ketosis'}], 'ancestors': [{'id': 'D009765', 'term': 'Obesity'}, {'id': 'D050177', 'term': 'Overweight'}, {'id': 'D044343', 'term': 'Overnutrition'}, {'id': 'D009748', 'term': 'Nutrition Disorders'}, {'id': 'D009750', 'term': 'Nutritional and Metabolic Diseases'}, {'id': 'D001835', 'term': 'Body Weight'}, {'id': 'D012816', 'term': 'Signs and Symptoms'}, {'id': 'D013568', 'term': 'Pathological Conditions, Signs and Symptoms'}, {'id': 'D000138', 'term': 'Acidosis'}, {'id': 'D000137', 'term': 'Acid-Base Imbalance'}, {'id': 'D008659', 'term': 'Metabolic Diseases'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 150}}, 'statusModule': {'overallStatus': 'RECRUITING', 'startDateStruct': {'date': '2024-03-25', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2024-04', 'completionDateStruct': {'date': '2025-08-01', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2024-04-01', 'studyFirstSubmitDate': '2024-03-24', 'studyFirstSubmitQcDate': '2024-03-24', 'lastUpdatePostDateStruct': {'date': '2024-04-03', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2024-04-01', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2025-04-01', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Cases of ketosis and incidence of ketoacidosis', 'timeFrame': 'The time frame is baseline, first 7 days, 1, 3, 6,12 months after surgery.', 'description': 'Compare the incidence of ketoacidosis and liver failure in three groups of patients with NASH with different intakes of carbohydrates in the early postoperative period after gastric bypass'}, {'measure': 'Cases of liver failure', 'timeFrame': 'The time frame is baseline, first 7 days, 1, 3, 6,12 months after surgery.', 'description': 'Compare the incidence of liver failure in three groups of patients with NASH with different intakes of carbohydrates in the early postoperative period after gastric bypass'}], 'secondaryOutcomes': [{'measure': 'Change in body mass index (Δ BMI)', 'timeFrame': 'The time frame is baseline,1, 3, 6,12 months after surgery.', 'description': 'This measurement assesses the change in BMI after the intervention. Weight (kg) and height (cm) will be combined in the BMI (kg/m2).'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['Carbohydrate restriction', 'Ketosis after bariatric surgery'], 'conditions': ['Obesity, Morbid', 'NASH', 'Ketosis', 'Keto Acidosis', 'Carbohydrate Metabolism Disorder']}, 'descriptionModule': {'briefSummary': 'Background:\n\nKetosis after bariatric surgery is a metabolic process that occurs when the body breaks down fat for energy because of not getting enough carbohydrates.\n\nInsufficient production of ketone bodies reduces the rate of weight loss, and excessive amounts of ketones can lead to ketoacidosis or liver failure in patients with nonalcoholic steatohepatitis (NASH).\n\nThe investigators hypothesize that weight loss is directly related to calorie intake, and a significant reduction in carbohydrate content leads to increased ketosis and the risk of ketoacidosis.\n\nObjectives:\n\nThe study aimed to compare the incidence of ketoacidosis and liver failure in patients with NASH with different intakes of carbohydrates in the early postoperative period after gastric bypass. In addition, the investigators want to find out how carbohydrate restriction will affect weight loss for up to 1 year.', 'detailedDescription': 'Methods:\n\nThis study is a three-arm randomized controlled trial. All patients will undergo laparoscopic one anastomotic gastric bypass. In the postoperative period, all patients will receive normal daily amounts of protein and fat. Depending on the amount of carbohydrates that will be received after surgery, patients will randomly (no mask) be divided into three groups:\n\nThe first group: 51-75% deficit in carbohydrates Second group: 26-50% deficit in carbohydrates The third group: has a 1-25% deficit in carbohydrates.\n\nPrimary outcome measurement Compare the incidence of ketoacidosis and liver failure in three groups of patients with NASH with different intakes of carbohydrates in the early postoperative period after gastric bypass.\n\nSecondary outcome measurements Change in body mass index (Δ BMI). Effect weight loss for up to 1 year.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT'], 'maximumAge': '60 Years', 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* obesity patients BMI 30-50 kg/m2.\n* patients with nonalcoholic steatohepatitis (NASH).\n\nExclusion Criteria:\n\n* patients with active physical sports\n* diabetes\n* cirrhosis'}, 'identificationModule': {'nctId': 'NCT06338969', 'briefTitle': 'The Impact of Different Carbohydrate Restriction After a Gastric Bypass on the Ketosis and Ketoacidosis', 'organization': {'class': 'OTHER', 'fullName': 'The Society of Bariatric and Metabolic Surgeons of Kazakhstan'}, 'officialTitle': 'The Impact of Different Carbohydrate Restriction After a Gastric Bypass on the Manifestation of Starvation Ketosis and Ketoacidosis in Patients With Nonalcoholic Steatohepatitis', 'orgStudyIdInfo': {'id': 'PostBariKetosis'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Carbohydrate Restriction after a Gastric Bypass: 51-75% deficit in carbohydrates', 'description': 'In the postoperative period, the amount of carbohydrate intake was reduced by counting carbohydrates in a glucose solution in the first three days after surgery and counting carbohydrates in food. Created a carbohydrate deficit of 51-75%.', 'interventionNames': ['Other: Carbohydrate Restriction after a Gastric Bypass']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'Carbohydrate Restriction after a Gastric Bypass: 26-50% deficit in carbohydrates', 'description': 'In the postoperative period, the amount of carbohydrate intake was reduced by counting carbohydrates in a glucose solution in the first three days after surgery and counting carbohydrates in food. Created a carbohydrate deficit: 26-50% deficit in carbohydrates.', 'interventionNames': ['Other: Carbohydrate Restriction after a Gastric Bypass']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'Carbohydrate Restriction after a Gastric Bypass:1-25% deficit in carbohydrates', 'description': 'In the postoperative period, the amount of carbohydrate intake was reduced by counting carbohydrates in a glucose solution in the first three days after surgery and counting carbohydrates in food. Created a carbohydrate deficit:1-25% deficit in carbohydrates.', 'interventionNames': ['Other: Carbohydrate Restriction after a Gastric Bypass']}], 'interventions': [{'name': 'Carbohydrate Restriction after a Gastric Bypass', 'type': 'OTHER', 'otherNames': ['laparoscopic one anastomotic gastric bypass'], 'description': 'All patients will undergo laparoscopic one anastomotic gastric bypass. In the postoperative period, all patients will receive normal daily amounts of protein and fat. Depending on the amount of carbohydrates that will be received after surgery, patients will randomly (no mask) be divided into three groups:\n\nThe first group: 51-75% deficit in carbohydrates Second group: 26-50% deficit in carbohydrates The third group: has a 1-25% deficit in carbohydrates.', 'armGroupLabels': ['Carbohydrate Restriction after a Gastric Bypass: 26-50% deficit in carbohydrates', 'Carbohydrate Restriction after a Gastric Bypass: 51-75% deficit in carbohydrates', 'Carbohydrate Restriction after a Gastric Bypass:1-25% deficit in carbohydrates']}]}, 'contactsLocationsModule': {'locations': [{'zip': '010000', 'city': 'Astana', 'state': 'Aqmola', 'status': 'RECRUITING', 'country': 'Kazakhstan', 'contacts': [{'name': 'Oral Ospanov, PhD', 'role': 'CONTACT', 'email': 'bariatric.kz@gmail.com', 'phone': '7015287734', 'phoneExt': '+7'}], 'facility': 'Oral Ospanov'}], 'centralContacts': [{'name': 'Oral Ospanov, PhD', 'role': 'CONTACT', 'email': 'bariatric.kz@gmail.com', 'phone': '7015287734', 'phoneExt': '+7'}, {'name': 'Bakhtiyar Yelembayev', 'role': 'CONTACT', 'email': 'elembaevbaha@gmail.com', 'phone': '7071302383', 'phoneExt': '+7'}], 'overallOfficials': [{'name': 'Oral Ospanov, PhD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'The Society of Bariatric and Metabolic Surgeons of Kazakhstan'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'The Society of Bariatric and Metabolic Surgeons of Kazakhstan', 'class': 'OTHER'}, 'responsibleParty': {'type': 'SPONSOR'}}}}