Ignite Creation Date:
2025-12-25 @ 12:17 AM
Ignite Modification Date:
2025-12-28 @ 6:27 PM
Study NCT ID:
NCT05896358
Status:
UNKNOWN
Last Update Posted:
2023-06-18
First Post:
2023-05-12
Is Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Dietary Treatment for Post Bariatric Weight Regain
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D009765', 'term': 'Obesity'}], 'ancestors': [{'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'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D055423', 'term': 'Diet, Ketogenic'}], 'ancestors': [{'id': 'D050528', 'term': 'Diet, Carbohydrate-Restricted'}, {'id': 'D004035', 'term': 'Diet Therapy'}, {'id': 'D044623', 'term': 'Nutrition Therapy'}, {'id': 'D013812', 'term': 'Therapeutics'}, {'id': 'D004032', 'term': 'Diet'}, {'id': 'D009747', 'term': 'Nutritional Physiological Phenomena'}, {'id': 'D000066888', 'term': 'Diet, Food, and Nutrition'}, {'id': 'D010829', 'term': 'Physiological Phenomena'}]}}, 'protocolSection': {'designModule': {'bioSpec': {'retention': 'SAMPLES_WITHOUT_DNA', 'description': 'plasma, stool'}, 'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'PROSPECTIVE', 'observationalModel': 'CASE_CONTROL'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 30}, 'patientRegistry': False}, 'statusModule': {'overallStatus': 'UNKNOWN', 'lastKnownStatus': 'ACTIVE_NOT_RECRUITING', 'startDateStruct': {'date': '2023-03-01', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2023-06', 'completionDateStruct': {'date': '2024-01-30', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2023-06-14', 'studyFirstSubmitDate': '2023-05-12', 'studyFirstSubmitQcDate': '2023-05-29', 'lastUpdatePostDateStruct': {'date': '2023-06-18', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2023-06-09', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2023-06-30', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'weight change', 'timeFrame': 'at baseline and right after the dietary intervention (8 weeks)', 'description': 'body mass change (kg) within and between groups'}], 'secondaryOutcomes': [{'measure': 'body fat change', 'timeFrame': 'at baseline and right after the dietary intervention (8 weeks)', 'description': 'body fat change (kg) within and between groups'}, {'measure': 'muscle mass change', 'timeFrame': 'at baseline and right after the dietary intervention (8 weeks)', 'description': 'lean mass change (kg) within and between groups'}, {'measure': 'waist circumference change', 'timeFrame': 'at baseline and right after the dietary intervention (8 weeks)', 'description': 'waist circumference change (cm) within and between groups'}, {'measure': 'mean blood pressure change', 'timeFrame': 'at baseline and right after the dietary intervention (8 weeks)', 'description': 'mean blood pressure change (mmHg) within and between groups'}, {'measure': 'glucose concentration change', 'timeFrame': 'at baseline and right after the dietary intervention (8 weeks)', 'description': 'glucose change (mg/dL) within and between groups'}, {'measure': 'insulin concentration change', 'timeFrame': 'at baseline and right after the dietary intervention (8 weeks)', 'description': 'insulin change (UI/mL) within and between groups'}, {'measure': 'uric acid concentration change', 'timeFrame': 'at baseline and right after the dietary intervention (8 weeks)', 'description': 'uric acid change (mg/dL) within and between groups'}, {'measure': 'creatinine concentration change', 'timeFrame': 'at baseline and right after the dietary intervention (8 weeks)', 'description': 'creatinine change (mg/dL) within and between groups'}, {'measure': 'cholesterol concentration change', 'timeFrame': 'at baseline and right after the dietary intervention (8 weeks)', 'description': 'cholesterol change (mg/dL) within and between groups'}, {'measure': 'triglycerides concentration change', 'timeFrame': 'at baseline and right after the dietary intervention (8 weeks)', 'description': 'triglycerides change (mg/dL) within and between groups'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Obesity']}, 'descriptionModule': {'briefSummary': 'Metabolic surgery has, among all obesity treatments, the best long term efficacy, but weight regain (weight regain, WR) or insufficient weight loss (IWL) are relatively common. These are hard to treat, with dietary treatment often failing, and redo surgery being commonly proposed.The ketogenic diet is vastly utilised to obtain weight loss in obesity, but little data is available regarding its application on post bariatric patients. Ad hoc designed studies are needed to confirm the efficacy and safety of a VLCKD in the treatment of WR and IWL. The aim of this study is to test whether the ketogenic diet is a safe and effective treatment in post bariatric weight regain, compared to its application before bariatric surgery.', 'detailedDescription': 'Metabolic surgery is, to date, the strategy for the treatment of obesity with the greatest long-term efficacy. However, especially in those lost to surgical and nutritional follow-up, weight regain (weight regain, WR) or insufficient weight loss (IWL) are relatively common. In particular, depending on the type of surgery considered, it has been observed that up to 40% of subjects undergoing surgery report a WR long term, where data on IWL are still insufficient to draw well-defined estimates. WR and IWL are hard to treat, with dietary treatment often failing, and redo surgery being commonly proposed, with increased risk of complications and little effect.\n\nThe ketogenic diet is one of the pivotal dietary therapies for the treatment of obesity, with excellent evidence in terms of weight loss and improvement in complications of excess weight. Very little data is available regarding its application on post bariatric patients: Correa and colleagues reported in a retrospective case series the efficacy and safety of a very low calorie ketogenic diet (VLCKD) in 11 patients with IWL or WR after gastric bypass, reporting a good safety profile, good tolerability, and an average weight loss of 9 kg in 2 months of therapy. Although promising, the data in the literature are extremely scarce, and therefore ad hoc designed studies are needed to confirm the efficacy and safety of a VLCKD in the treatment of WR and IWL.\n\nThe objective of this study is to test whether the application of a ketogenic diet is a safe and effective treatment in post bariatric weight regain, compared to its application before bariatric surgery.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'samplingMethod': 'PROBABILITY_SAMPLE', 'studyPopulation': 'Pre bariatric treatment arm will be composed of:\n\n-individuals with no history of bariatric surgery\n\nPost bariatric treatment arm will be composed of:\n\n* individuals with previous metabolic surgery (RYGB or Sleeve gastrectomy) and\n* excess WL \\< 50% at 18 months after surgery (IWL) or\n* clinically relevant WR after satisfactory WL', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\n-obesity (BMI ≥ 30 Kg/m2)\n\nExclusion Criteria:\n\n* Type 1 diabetes mellitus\n* Renal failure (GFR\\<60)\n* Liver failure (decompensated cirrhosis)\n* Congenital metabolic diseases\n* Pregnancy\n* lactation\n* Major psychiatric disorder\n* Alcoholism\n* drug addiction\n* patients who are not self-sufficient and without adequate family and social support'}, 'identificationModule': {'nctId': 'NCT05896358', 'acronym': 'WRKD', 'briefTitle': 'Dietary Treatment for Post Bariatric Weight Regain', 'organization': {'class': 'OTHER', 'fullName': 'University of Roma La Sapienza'}, 'officialTitle': 'Dietary Treatment for Post Bariatric Weight Regain:Evaluation of the Efficacy of a KD', 'orgStudyIdInfo': {'id': '2023KDWR'}}, 'armsInterventionsModule': {'armGroups': [{'label': 'Bariatric naive', 'description': 'patients with obesity who have not undergone bariatric surgery in the past', 'interventionNames': ['Behavioral: ketogenic diet']}, {'label': 'Post Bariatric', 'description': 'patients with obesity who have undergone bariatric surgery in the past and have experienced weight regain or insufficient weight loss', 'interventionNames': ['Behavioral: ketogenic diet']}], 'interventions': [{'name': 'ketogenic diet', 'type': 'BEHAVIORAL', 'description': 'a low calorie ketogenic diet', 'armGroupLabels': ['Bariatric naive', 'Post Bariatric']}]}, 'contactsLocationsModule': {'locations': [{'zip': '00161', 'city': 'Roma', 'country': 'Italy', 'facility': 'Sapienza University of Rome', 'geoPoint': {'lat': 44.99364, 'lon': 11.10642}}], 'overallOfficials': [{'name': 'lucio gnessi', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'sapienza università di roma'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'University of Roma La Sapienza', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Full professor', 'investigatorFullName': 'Lucio Gnessi', 'investigatorAffiliation': 'University of Roma La Sapienza'}}}}