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Trial details imported from ClinicalTrials.gov
For full trial details, please see the original record at
https://clinicaltrials.gov/study/NCT01486680
Registration number
NCT01486680
Ethics application status
Date submitted
28/11/2011
Date registered
6/12/2011
Date last updated
28/09/2021
Titles & IDs
Public title
Silastic Ring Gastric Bypass Versus Sleeve Gastrectomy for Type 2 Diabetes Mellitus in Obese Patients
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Scientific title
Prospective Randomised Controlled Trial Comparing the Efficacy of Laparoscopic Silastic Ring Roux-en-Y Gastric Bypass Versus Laparoscopic Sleeve Gastrectomy for the Management of Type 2 Diabetes Mellitus in Obese Patients
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Secondary ID [1]
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ACTRN12611000751976
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Secondary ID [2]
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NTY/11/07/082
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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
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Diabetes
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Intervention/exposure
Study type
Interventional
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Description of intervention(s) / exposure
Treatment: Surgery - Laparoscopic Silastic Ring Roux-en-Y Gastric Bypass
Treatment: Surgery - Laparoscopic Sleeve gastrectomy
Active comparator: Laparoscopic Silastic Ring Roux-en-Y Gastric Bypass -
Active comparator: Laparoscopic Sleeve Gastrectomy -
Treatment: Surgery: Laparoscopic Silastic Ring 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.
Treatment: Surgery: Laparoscopic Sleeve gastrectomy
Resection of the greater curvature of the stomach from the distal antrum (2cm 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
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Intervention code [1]
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Treatment: Surgery
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Comparator / control treatment
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Control group
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Outcomes
Primary outcome [1]
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Remission of type 2 diabetes mellitus/ glycaemic control
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Assessment method [1]
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COMPLETE:Defined as fasting plasma glucose less than 5.6mmol/L and glycated haemoglobin (HbA1c) less than 6.0% in the abscence of active pharmacologic therapy PARTIAL:Defined as fasting plasma glucose between 5.6 and 6.9mmol/L and glycated haemoglobin (HbA1c) between 6.0 and 6.5% in the abscence of active pharmacologic therapy
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Timepoint [1]
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5 years
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Secondary outcome [1]
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Comorbidity resolution
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Assessment method [1]
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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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Timepoint [1]
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5 years
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Secondary outcome [2]
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Peri/ post-operative morbidity and mortality
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Assessment method [2]
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For example haemorrhage, thromboembolic events, cardiorespiratory events, marginal ulceration, anastomotic / staple line leak, internal herniation, nutritional deficiencies and mortality
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Timepoint [2]
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30-day, In-hospital, 1 year and 5 years
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Secondary outcome [3]
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Changes in body composition, resting energy expenditure and bone density
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Assessment method [3]
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Includes use of dual energy x-ray absorptiometry (DEXA)
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Timepoint [3]
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1 year and 5 years
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Secondary outcome [4]
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Quality of Life
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Assessment method [4]
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Qualitative scores using Short Form-36 and Hospital and Anxiety depression scale
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Timepoint [4]
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1 year and 5 years
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Eligibility
Key inclusion criteria
* Aged 20 to 50 years old
* Body mass index 35-65
* Type 2 diabetes mellitus for at least 6 months
* Suitable for either of the two surgical procedures
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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?
Yes
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Key exclusion criteria
* Aged >50 years
* BMI >65
* Type 1 diabetes mellitus or secondary forms of diabetes
* Previous bariatric or oesophagogastric surgery
* Previous small bowel resection
* Severe cardiorespiratory or gastrointestinal disease
* Myocardial infarction or cerebrovascular event within last 6 months
* Malignancy in last 5 years
* Poorly controlled psychiatric disorder
* Contraindication to general anaesthesia
* Current smoker
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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)
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Methods used to generate the sequence in which subjects will be randomised (sequence generation)
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Masking / blinding
Blinded (masking used)
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Who is / are masked / blinded?
The people receiving the treatment/s
The people assessing the outcomes
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Intervention assignment
Parallel
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Other design features
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Phase
NA
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Type of endpoint/s
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Statistical methods / analysis
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Recruitment
Recruitment status
Completed
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Data analysis
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Reason for early stopping/withdrawal
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Other reasons
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Date of first participant enrolment
Anticipated
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Actual
1/09/2011
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Date of last participant enrolment
Anticipated
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Actual
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Date of last data collection
Anticipated
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Actual
1/10/2019
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Sample size
Target
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Accrual to date
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Final
106
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Recruitment in Australia
Recruitment state(s)
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Recruitment outside Australia
Country [1]
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New Zealand
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State/province [1]
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Auckland
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Funding & Sponsors
Primary sponsor type
Other
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Name
North Shore Hospital, New Zealand
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Address
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Country
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Ethics approval
Ethics application status
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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
https://clinicaltrials.gov/study/NCT01486680
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Trial related presentations / publications
Kaur R, Kim D, Cutfield R, Booth M, Plank L, Murphy R. Good Glycemic Outcomes Following Bariatric Surgery Among Patients With Type 2 Diabetes, Obesity, and Low-Titer GAD Antibodies. Diabetes Care. 2021 Feb;44(2):607-609. doi: 10.2337/dc20-0804. Epub 2020 Dec 11. Murphy R, Clarke MG, Evennett NJ, John Robinson S, Lee Humphreys M, Hammodat H, Jones B, Kim DD, Cutfield R, Johnson MH, Plank LD, Booth MWC. Laparoscopic Sleeve Gastrectomy Versus Banded Roux-en-Y Gastric Bypass for Diabetes and Obesity: a Prospective Randomised Double-Blind Trial. Obes Surg. 2018 Feb;28(2):293-302. doi: 10.1007/s11695-017-2872-6. Murphy R, Evennett NJ, Clarke MG, Robinson SJ, Humphreys L, Jones B, Kim DD, Cutfield R, Plank LD, Hammodat H, Booth MW. Sleeve gastrectomy versus Roux-en-Y gastric bypass for type 2 diabetes and morbid obesity: double-blind randomised clinical trial protocol. BMJ Open. 2016 Jul 4;6(7):e011416. doi: 10.1136/bmjopen-2016-011416.
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Public notes
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Contacts
Principal investigator
Name
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Michael Booth, MBA FRACS
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Address
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North Shore Hospital, Auckland, NEW ZEALAND
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Country
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Phone
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Fax
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Email
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Contact person for public queries
Name
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Address
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Country
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Phone
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Fax
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Email
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Contact person for scientific queries
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
No documents have been uploaded by study researchers.
Results not provided in
https://clinicaltrials.gov/study/NCT01486680
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