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Trial registered on ANZCTR
Registration number
ACTRN12611000751976
Ethics application status
Approved
Date submitted
10/07/2011
Date registered
18/07/2011
Date last updated
21/05/2014
Type of registration
Prospectively registered
Titles & IDs
Public title
Prospective randomised controlled trial comparing the efficacy of laparoscopic Roux-en-Y gastric bypass versus laparoscopic sleeve gastrectomy for the management of type 2 diabetes mellitus in obese patients
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Scientific title
Type 2 diabetes remission in obese patients: A randomised controlled study of laparoscopic Roux-en-Y gastric bypass versus laparoscopic sleeve gastrectomy
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Secondary ID [1]
262595
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Nil
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Universal Trial Number (UTN)
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Trial acronym
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Linked study record
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Health condition
Health condition(s) or problem(s) studied:
Type 2 diabetes mellitus
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Obesity
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Condition category
Condition code
Metabolic and Endocrine
268411
268411
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0
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Diabetes
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Surgery
268412
268412
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0
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Surgical techniques
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Diet and Nutrition
268413
268413
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0
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Obesity
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Intervention/exposure
Study type
Interventional
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Description of intervention(s) / exposure
Arm 1: Laparoscopic sleeve gastrectomy - resection of the greater curvature of the stomach from the distal antrum (3 cm proximal to pylorus) to the angle of His, using a laparoscopic stapling device over a 36Fr bougie, will be performed to create a lesser curve gastric sleeve. Approximate duration of procedure: 60-120 minutes.
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Intervention code [1]
266932
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Treatment: Surgery
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Comparator / control treatment
Arm 2: Laparoscopic Roux-en-Y gastric bypass - An isolated lesser curve-based gastric pouch will be created, with an antecolic antegastric Roux limb fashioned measuring 100 cm in length. The biliopancreatic limb will measure 50cm for all patients. A 6.5cm silastic ring will be placed above the gastrojejunostomy to prevent long term stomal dilatation. Approximate duration of procedure: 90-120 minutes.
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Control group
Active
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Outcomes
Primary outcome [1]
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Remission of Type 2 diabetes mellitus as follows:-
Complete remission = Fasting plasma glucose less than 5.6 mmol/L and glycated haemoglobin (HbA1c) less than 6.0% in the absence of active pharmacologic therapy
Partial remission = Fasting plasma glucose between 5.6 and 6.9 mmol/L and glycated haemoglobin (HbA1c) between 6.0 and 6.5% in the absence of active pharmacologic therapy
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Assessment method [1]
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Timepoint [1]
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At one year and five years after randomisation
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Secondary outcome [1]
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Weight change (excess weight loss and total body weight loss) including change in Body Mass Index
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Assessment method [1]
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Timepoint [1]
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One year and five years after randomisation
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Secondary outcome [2]
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Comorbidity resolution (measurement of changes in blood pressure, blood lipid profile, obstructive sleep apnoea symptoms and CPAP usage, urinary incontinence frequency, angina severity, reflux symptoms using Visick scale, medication changes)
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Assessment method [2]
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Timepoint [2]
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One year and five years after randomisation
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Secondary outcome [3]
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Peri and post-operative complications (e.g. haemorrhage, thromboembolic events, cardiorespiratory events, marginal ulceration, anastomotic / staple line leak, internal herniation, nutritional deficiencies) and mortality
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Assessment method [3]
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Timepoint [3]
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30-days after surgery
In-hospital - i.e. events occurring in hospital during
the primary admission for surgery
One year and five years after randomisation
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Secondary outcome [4]
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Change in body composition, resting energy expenditure and bone density (using dual energy x-ray absorptiometry (DEXA) scanning and bioimpedance measurement techniques).
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Assessment method [4]
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Timepoint [4]
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One year and five years after randomisation
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Secondary outcome [5]
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Quality of Life (using Short from 36 and Hospital and Anxiety depression scale)
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Assessment method [5]
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Timepoint [5]
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At three monthly time points during first year after surgery, six monthly during the second year, then yearly until five years after randomisation
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Eligibility
Key inclusion criteria
-Type 2 Diabetes Mellitus for at least 6 months
-Previous failed attempts at weight loss through dieting and exercise
-BMI 35 - 65 kg/m2 for at least 5 years
-Suitable for either of the two surgical procedures
-Able to give informed consent
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Minimum age
20
Years
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Maximum age
50
Years
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Sex
Both males and females
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Can healthy volunteers participate?
No
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Key exclusion criteria
-Type 1 diabetes mellitus
-Previous bariatric or oesophagogastric surgery
-Poorly controlled psychiatric disorder
-Myocardial infarction, heart bypass surgery or stroke within 6 months
-Malignancy in last 5 years
-Not suitable for general anaesthesia
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Study design
Purpose of the study
Treatment
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Allocation to intervention
Randomised controlled trial
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Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Surgeon assesses patient in the outpatient clinic to determine if a suitable candidate for either type of bariatric surgical procedure.
Allocation will be concealed using sealed opaque envelopes. The envelope will be opened in theatre once the patient is anaesthetised and the procedure will then be disclosed to the operating surgeon.
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Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Randomisation with minimisation based on age (grouped as 20-30, 30-40, 40-50); time since diagnosis of T2DM (grouped as <5yrs, 5-10yrs, >10yrs) and ethnicity (grouped as Maori, Pacific, European or other). Randomisation will be computer generated with allocation concealment.
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Masking / blinding
Blinded (masking used)
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Who is / are masked / blinded?
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Intervention assignment
Parallel
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Other design features
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Phase
Not Applicable
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Type of endpoint/s
Safety/efficacy
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Statistical methods / analysis
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Recruitment
Recruitment status
Recruiting
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Date of first participant enrolment
Anticipated
6/09/2011
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Actual
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Date of last participant enrolment
Anticipated
3/09/2014
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Actual
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Date of last data collection
Anticipated
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Actual
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Sample size
Target
106
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Accrual to date
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Final
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Recruitment outside Australia
Country [1]
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New Zealand
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State/province [1]
3703
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Funding & Sponsors
Funding source category [1]
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Hospital
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Name [1]
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Waitemata District Health Board
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Address [1]
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North Shore Hospital
Shakespeare Road
Takapuna
Private Bag 93 503
Auckland 0740
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Country [1]
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New Zealand
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Primary sponsor type
Hospital
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Name
Waitemata District Health Board
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Address
North Shore Hospital
Shakespeare Road
Takapuna
Private Bag 93 503
Auckland 0740
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Country
New Zealand
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Secondary sponsor category [1]
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None
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Name [1]
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Address [1]
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Country [1]
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Ethics approval
Ethics application status
Approved
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Ethics committee name [1]
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Northern Y Regional Ethics Committee
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Ethics committee address [1]
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C/O Ministry of Health, PO Box 1031, Hamilton 3240
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Ethics committee country [1]
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New Zealand
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Date submitted for ethics approval [1]
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12/07/2011
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Approval date [1]
269436
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Ethics approval number [1]
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NTY/11/07/082
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Summary
Brief summary
Type 2 diabetes (T2DM) and obesity are becoming increasingly common in New Zealand (NZ) and worldwide. Both are associated with a risk of early mortality (death). Whilst weight loss surgery is known to be effective for weight loss, current research suggests that it may also be effective in resolving T2DM in around 60-80% of patients, with some no longer requiring their medication. The mechanism for this remains unclear.
Two main types of weight loss surgery are performed in NZ public hospitals, which include gastric bypass and sleeve gastrectomy. The gastric bypass is a more complex procedure compared to the sleeve gastrectomy. Whilst both appear to be effective for weight loss (with most patients losing more than 60% of their excess weight), it is still not known which one is better for treating T2DM.
This study will therefore compare which of these two surgical procedures is most effective at treating T2DM in obese patients, as well as comparing whether there are any differences in the amount of weight lost, side effects and quality of life.
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Trial website
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Trial related presentations / publications
Nil yet
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Public notes
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Contacts
Principal investigator
Name
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Mr Michael Booth
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Address
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Consultant Laparoscopic Upper GI & Bariatric Surgeon Department of General Surgery North Shore Hospital Shakespeare Road, Private Bag 93 503 Takapuna Auckland 0740
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Country
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New Zealand
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Phone
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+64 9 486 8900 Ext 2459
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Fax
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Email
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[email protected]
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Contact person for public queries
Name
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Mr Mr Michael Booth
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Address
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Consultant Laparoscopic Upper GI & Bariatric Surgeon
Department of General Surgery
North Shore Hospital
Shakespeare Road, Private Bag 93 503
Takapuna
Auckland 0740
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Country
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New Zealand
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Phone
16099
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+64 9 486 8900 Ext 2459
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Fax
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Email
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[email protected]
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Contact person for scientific queries
Name
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Mr Mr Michael Booth
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Address
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Consultant Laparoscopic Upper GI & Bariatric Surgeon
Department of General Surgery
North Shore Hospital
Shakespeare Road, Private Bag 93 503
Takapuna
Auckland 0740
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Country
7027
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New Zealand
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Phone
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+64 9 486 8900 Ext 2459
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Fax
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Email
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[email protected]
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No information has been provided regarding IPD availability
What supporting documents are/will be available?
No Supporting Document Provided
Results publications and other study-related documents
Documents added manually
Current Study Results
No documents have been uploaded by study researchers.
Update to Study Results
Doc. No.
Type
Is Peer Reviewed?
DOI
Citations or Other Details
Attachment
4311
Study results article
Yes
Laparoscopic sleeve gastrectomy versus banded Roux...
[
More Details
]
Documents added automatically
Source
Title
Year of Publication
DOI
Embase
Laparoscopic Sleeve Gastrectomy Versus Banded Roux-en-Y Gastric Bypass for Diabetes and Obesity: a Prospective Randomised Double-Blind Trial.
2018
https://dx.doi.org/10.1007/s11695-017-2872-6
Embase
Bariatric Surgery and Psychological Health: A Randomised Clinical Trial in Patients with Obesity and Type 2 Diabetes.
2023
https://dx.doi.org/10.1007/s11695-023-06537-y
Embase
Fibroblast growth factor 23 levels decline following sleeve gastrectomy.
2019
https://dx.doi.org/10.1111/cen.13981
Embase
Gut Microbial Predictors of Type 2 Diabetes Remission Following Bariatric Surgery.
2020
https://dx.doi.org/10.1007/s11695-020-04684-0
Embase
Increased Bile Acids and FGF19 After Sleeve Gastrectomy and Roux-en-Y Gastric Bypass Correlate with Improvement in Type 2 Diabetes in a Randomized Trial.
2018
https://dx.doi.org/10.1007/s11695-018-3216-x
Embase
Sleeve gastrectomy versus Roux-en-Y gastric bypass for type 2 diabetes and morbid obesity: Double-blind randomised clinical trial protocol.
2016
https://dx.doi.org/10.1136/bmjopen-2016-011416
N.B. These documents automatically identified may not have been verified by the study sponsor.
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