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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
Scientific title
Type 2 diabetes remission in obese patients: A randomised controlled study of laparoscopic Roux-en-Y gastric bypass versus laparoscopic sleeve gastrectomy
Secondary ID [1] 262595 0
Nil
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Type 2 diabetes mellitus 268277 0
Obesity 268305 0
Condition category
Condition code
Metabolic and Endocrine 268411 268411 0 0
Diabetes
Surgery 268412 268412 0 0
Surgical techniques
Diet and Nutrition 268413 268413 0 0
Obesity

Intervention/exposure
Study type
Interventional
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.
Intervention code [1] 266932 0
Treatment: Surgery
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.
Control group
Active

Outcomes
Primary outcome [1] 269175 0
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
Timepoint [1] 269175 0
At one year and five years after randomisation
Secondary outcome [1] 279066 0
Weight change (excess weight loss and total body weight loss) including change in Body Mass Index
Timepoint [1] 279066 0
One year and five years after randomisation
Secondary outcome [2] 279067 0
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)
Timepoint [2] 279067 0
One year and five years after randomisation
Secondary outcome [3] 279068 0
Peri and post-operative complications (e.g. haemorrhage, thromboembolic events, cardiorespiratory events, marginal ulceration, anastomotic / staple line leak, internal herniation, nutritional deficiencies) and mortality
Timepoint [3] 279068 0
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
Secondary outcome [4] 279069 0
Change in body composition, resting energy expenditure and bone density (using dual energy x-ray absorptiometry (DEXA) scanning and bioimpedance measurement techniques).
Timepoint [4] 279069 0
One year and five years after randomisation
Secondary outcome [5] 279070 0
Quality of Life (using Short from 36 and Hospital and Anxiety depression scale)
Timepoint [5] 279070 0
At three monthly time points during first year after surgery, six monthly during the second year, then yearly until five years after randomisation

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
Minimum age
20 Years
Maximum age
50 Years
Sex
Both males and females
Can healthy volunteers participate?
No
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

Study design
Purpose of the study
Treatment
Allocation to intervention
Randomised controlled trial
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.
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.
Masking / blinding
Blinded (masking used)
Who is / are masked / blinded?



Intervention assignment
Parallel
Other design features
Phase
Not Applicable
Type of endpoint/s
Safety/efficacy
Statistical methods / analysis

Recruitment
Recruitment status
Recruiting
Date of first participant enrolment
Anticipated
6/09/2011
Actual
Date of last participant enrolment
Anticipated
3/09/2014
Actual
Date of last data collection
Anticipated
Actual
Sample size
Target
106
Accrual to date
Final
Recruitment outside Australia
Country [1] 3703 0
New Zealand
State/province [1] 3703 0

Funding & Sponsors
Funding source category [1] 267410 0
Hospital
Name [1] 267410 0
Waitemata District Health Board
Country [1] 267410 0
New Zealand
Primary sponsor type
Hospital
Name
Waitemata District Health Board
Address
North Shore Hospital
Shakespeare Road
Takapuna
Private Bag 93 503
Auckland 0740
Country
New Zealand
Secondary sponsor category [1] 266466 0
None
Name [1] 266466 0
Address [1] 266466 0
Country [1] 266466 0

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 269436 0
Northern Y Regional Ethics Committee
Ethics committee address [1] 269436 0
Ethics committee country [1] 269436 0
New Zealand
Date submitted for ethics approval [1] 269436 0
12/07/2011
Approval date [1] 269436 0
Ethics approval number [1] 269436 0
NTY/11/07/082

Summary
Brief summary
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 32852 0
Mr Michael Booth
Address 32852 0
Consultant Laparoscopic Upper GI & Bariatric Surgeon Department of General Surgery North Shore Hospital Shakespeare Road, Private Bag 93 503 Takapuna Auckland 0740
Country 32852 0
New Zealand
Phone 32852 0
+64 9 486 8900 Ext 2459
Fax 32852 0
Email 32852 0
michael.booth@waitematadhb.govt.nz
Contact person for public queries
Name 16099 0
Mr Michael Booth
Address 16099 0
Consultant Laparoscopic Upper GI & Bariatric Surgeon
Department of General Surgery
North Shore Hospital
Shakespeare Road, Private Bag 93 503
Takapuna
Auckland 0740
Country 16099 0
New Zealand
Phone 16099 0
+64 9 486 8900 Ext 2459
Fax 16099 0
Email 16099 0
michael.booth@waitematadhb.govt.nz
Contact person for scientific queries
Name 7027 0
Mr Michael Booth
Address 7027 0
Consultant Laparoscopic Upper GI & Bariatric Surgeon
Department of General Surgery
North Shore Hospital
Shakespeare Road, Private Bag 93 503
Takapuna
Auckland 0740
Country 7027 0
New Zealand
Phone 7027 0
+64 9 486 8900 Ext 2459
Fax 7027 0
Email 7027 0
michael.booth@waitematadhb.govt.nz

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
TypeIs Peer Reviewed?DOICitations or Other DetailsAttachment
Study results articleYes Laparoscopic sleeve gastrectomy versus banded Roux... [More Details]

Documents added automatically
SourceTitleYear of PublicationDOI
EmbaseSleeve gastrectomy versus Roux-en-Y gastric bypass for type 2 diabetes and morbid obesity: Double-blind randomised clinical trial protocol.2016https://dx.doi.org/10.1136/bmjopen-2016-011416
EmbaseIncreased Bile Acids and FGF19 After Sleeve Gastrectomy and Roux-en-Y Gastric Bypass Correlate with Improvement in Type 2 Diabetes in a Randomized Trial.2018https://dx.doi.org/10.1007/s11695-018-3216-x
EmbaseLaparoscopic Sleeve Gastrectomy Versus Banded Roux-en-Y Gastric Bypass for Diabetes and Obesity: a Prospective Randomised Double-Blind Trial.2018https://dx.doi.org/10.1007/s11695-017-2872-6
EmbaseFibroblast growth factor 23 levels decline following sleeve gastrectomy.2019https://dx.doi.org/10.1111/cen.13981
EmbaseGut Microbial Predictors of Type 2 Diabetes Remission Following Bariatric Surgery.2020https://dx.doi.org/10.1007/s11695-020-04684-0
EmbaseBariatric Surgery and Psychological Health: A Randomised Clinical Trial in Patients with Obesity and Type 2 Diabetes.2023https://dx.doi.org/10.1007/s11695-023-06537-y
N.B. These documents automatically identified may not have been verified by the study sponsor.