Ignite Creation Date:
2025-12-24 @ 11:10 PM
Ignite Modification Date:
2026-03-29 @ 12:37 PM
Study NCT ID:
NCT03125369
Status:
UNKNOWN
Last Update Posted:
2017-04-24
First Post:
2016-04-29
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Single Loop DJB Sleeve Gastrectomy for Poorly Controlled T2DM
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D003920', 'term': 'Diabetes Mellitus'}, {'id': 'D009765', 'term': 'Obesity'}, {'id': 'D015431', 'term': 'Weight Loss'}], 'ancestors': [{'id': 'D044882', 'term': 'Glucose Metabolism Disorders'}, {'id': 'D008659', 'term': 'Metabolic Diseases'}, {'id': 'D009750', 'term': 'Nutritional and Metabolic Diseases'}, {'id': 'D004700', 'term': 'Endocrine System Diseases'}, {'id': 'D050177', 'term': 'Overweight'}, {'id': 'D044343', 'term': 'Overnutrition'}, {'id': 'D009748', 'term': 'Nutrition Disorders'}, {'id': 'D001835', 'term': 'Body Weight'}, {'id': 'D012816', 'term': 'Signs and Symptoms'}, {'id': 'D013568', 'term': 'Pathological Conditions, Signs and Symptoms'}, {'id': 'D001836', 'term': 'Body Weight Changes'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D015390', 'term': 'Gastric Bypass'}], 'ancestors': [{'id': 'D050110', 'term': 'Bariatric Surgery'}, {'id': 'D049088', 'term': 'Bariatrics'}, {'id': 'D000073319', 'term': 'Obesity Management'}, {'id': 'D013812', 'term': 'Therapeutics'}, {'id': 'D005763', 'term': 'Gastroenterostomy'}, {'id': 'D000714', 'term': 'Anastomosis, Surgical'}, {'id': 'D013514', 'term': 'Surgical Procedures, Operative'}, {'id': 'D013505', 'term': 'Digestive System Surgical Procedures'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'SINGLE', 'whoMasked': ['PARTICIPANT']}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 80}}, 'statusModule': {'overallStatus': 'UNKNOWN', 'lastKnownStatus': 'RECRUITING', 'startDateStruct': {'date': '2015-08'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2017-04', 'completionDateStruct': {'date': '2018-05', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2017-04-19', 'studyFirstSubmitDate': '2016-04-29', 'studyFirstSubmitQcDate': '2017-04-19', 'lastUpdatePostDateStruct': {'date': '2017-04-24', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2017-04-24', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2018-05', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': '% of patient achieve HbA1c<6%', 'timeFrame': '1 year'}], 'secondaryOutcomes': [{'measure': 'operation time', 'timeFrame': 'during operation'}, {'measure': 'Total blood loss', 'timeFrame': 'during operation', 'description': 'Total blood loss data from operation record'}, {'measure': 'Perioperative complications', 'timeFrame': '30 days'}, {'measure': 'mortality', 'timeFrame': '30 days'}, {'measure': 'Postoperative hospital stay', 'timeFrame': 'during index operation'}, {'measure': 'Excessive body weight loss (kg)', 'timeFrame': '6 months & 1 year'}, {'measure': 'BMI change (kg/m^2)', 'timeFrame': '6 months & 1 year'}]}, 'oversightModule': {'oversightHasDmc': True}, 'conditionsModule': {'conditions': ['Diabetes Mellitus', 'Obesity', 'Bariatric Surgery Candidate', 'Weight Loss']}, 'descriptionModule': {'briefSummary': 'Type 2 diabetes mellitus (T2DM) is a chronic progressive illness affecting a substantial percentage of the general population. While pharmacotherapy remains the mainstay of treatment, around 60% of patients cannot achieve the recommended goals for diabetic control. Weight control is a well-known essential component in normalizing blood glucose level in T2DM. The term metabolic surgery is recently introduced and it is now increasingly accepted as a valid option for obese T2DM patients with poor glycemic control despite optimal medical therapy. While laparoscopic roux-en-Y gastric bypass (RYGBP) is the gold-standard bariatric/metabolic procedure in many countries, it is not widely accepted in Asia. Recently, a novel bypass technique called single loop duodenojejunal bypass with sleeve gastrectomy (SLDJB-SG) has been developed trying to tackle most drawbacks of RYGBP. Realizing there is a knowledge gap in applying the new duodenojejunal bypass procedure to obese T2DM patients, we propose to investigate and compare the efficacy of glycemic control and functional outcomes of SLDJB-SG with conventional RYGBP.', 'detailedDescription': 'Aim of study:\n\nTo investigate and compare the safety profile, functional outcomes, efficacy in diabetic control and changes of hormonal profile of laparoscopic single loop duodenojejunal bypass plus sleeve gastrectomy (SLDJB-SG) versus the conventional standard roux-en-Y gastric bypass (RYGBP).\n\nHypothesis:\n\nThe efficacy of glycemic control and functional outcomes of SLDJB-SG is better than conventional RYGBP, and is a more suitable option for obese Chinese diabetic patients.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '65 Years', 'minimumAge': '20 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* aged between 20 to 65 years\n* at least 2 years of T2DM\n* a BMI between 28 to 42 kg/m2\n* a HbA1c level above 7% despite multiple oral medications (\\> 2) at higher than or equal to half-maximal dose, or already using insulin injection for more than 6 months\n* no active cardiovascular diseases, and\n* a ASA grade II or below\n* a fasting C-peptide \\< 0.6ug/L\n\nExclusion Criteria:\n\n* significant anaesthetic risk ASA grade III or above\n* history of diabetic ketoacidosis\n* uncontrolled DM with HbA1c \\> 12%\n* malignancy diagnosed within 5 years\n* chronic renal failure requiring dialysis\n* previous upper abdominal surgery affecting gastroduodenal configuration\n* major psychiatric illness including major depression and substance abuse\n* pregnancy or ongoing breast-feeding\n* inmates'}, 'identificationModule': {'nctId': 'NCT03125369', 'briefTitle': 'Single Loop DJB Sleeve Gastrectomy for Poorly Controlled T2DM', 'organization': {'class': 'OTHER', 'fullName': 'Chinese University of Hong Kong'}, 'officialTitle': 'Prospective Randomized Trial Comparing Single Loop Duodenojejunal Bypass With Sleeve Gastrectomy Versus Standard Roux-en-Y Gastric Bypass in Patients With Poorly Controlled Type 2 Diabetes Mellitus: From Clinical Outcomes to Hormonal Mechanism', 'orgStudyIdInfo': {'id': 'SLDJBSG_DM'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Duodenojejunal bypass', 'description': 'patients receive sleeve gastrectomy plus duodeno-jejunal bypass', 'interventionNames': ['Procedure: Sleeve gastrectomy + duodeno-jejunal bypass']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'Roux-en-Y gastric bypass', 'description': 'patients receive roux-Y gastric bypass', 'interventionNames': ['Procedure: Roux-Y gastric bypass']}], 'interventions': [{'name': 'Sleeve gastrectomy + duodeno-jejunal bypass', 'type': 'PROCEDURE', 'armGroupLabels': ['Duodenojejunal bypass']}, {'name': 'Roux-Y gastric bypass', 'type': 'PROCEDURE', 'armGroupLabels': ['Roux-en-Y gastric bypass']}]}, 'contactsLocationsModule': {'locations': [{'city': 'Hong Kong', 'status': 'RECRUITING', 'country': 'China', 'contacts': [{'name': 'Enders Ng, MD', 'role': 'CONTACT', 'email': 'endersng@surgery.cuhk.edu.hk', 'phone': '+852 26322956'}], 'facility': 'Chinese University of Hong Kong', 'geoPoint': {'lat': 22.27832, 'lon': 114.17469}}], 'centralContacts': [{'name': 'Enders Ng, MD', 'role': 'CONTACT', 'email': 'endersng@surgery.cuhk.edu.hk', 'phone': '+852 26322956'}, {'name': 'Candice Lam, BN', 'role': 'CONTACT', 'email': 'candicelam@surgery.cuhk.edu.hk', 'phone': '+852 26322956'}], 'overallOfficials': [{'name': 'Enders KW Ng, Professor', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Chinese University of Hong Kong'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'UNDECIDED'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Chinese University of Hong Kong', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Professor', 'investigatorFullName': 'Enders K.W. Ng', 'investigatorAffiliation': 'Chinese University of Hong Kong'}}}}