AzTrials
AzTrials

Type 2 Diabetes MellitusNCT01486680

Silastic Ring Gastric Bypass Versus Sleeve Gastrectomy for Type 2 Diabetes Mellitus in Obese Patients

A study testing Laparoscopic Silastic Ring Roux-en-Y Gastric Bypass and Laparoscopic Sleeve gastrectomy in people with Type 2 Diabetes Mellitus and Obesity, run by North Shore Hospital, New Zealand at 2 sites in New Zealand.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
Search all trials

Trial 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… Read more about this study

Who is it for?
Ages 20 to 50 yearsHealthy volunteers can take part
Conditions the study is for
Type 2 Diabetes Mellitus, Obesity
What is being tested?
Laparoscopic Silastic Ring Roux-en-Y Gastric Bypass and Laparoscopic Sleeve gastrectomy
Type of treatment
Surgery or procedure
Could I receive a placebo?
No, everyone receives an active treatment
How many people
106 participants
Where
2 sitesNew Zealand
Study dates
Sep 2011to Oct 2019
Phase
Interventional
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 20 to 50 years
  • All sexes
  • Healthy volunteers accepted
  • Adult

Who may be able to join

  • 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

Who cannot join

  • 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
Show all 11Show fewer
  • Myocardial infarction or cerebrovascular event within last 6 months
  • Malignancy in last 5 years
  • Poorly controlled psychiatric disorder
  • Contraindication to general anaesthesia
  • Current smoker

Trial locations and contacts

2 sites in 1 country.

New Zealand2 sites
  • North Shore Hospital

    Auckland, 0622

  • University of Auckland

    Auckland

Other trials in New Zealand

About this study

Official 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

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.

Read the detailed description

EFFECTS OF DIABETES AND OBESITY The World Health Organization indicates that 346 million people worldwide have diabetes. This is expected to double between 2005 and 2030. Type 2 diabetes mellitus (T2DM) accounts for 90% of people with diabetes and is known to result from a combination of physical inactivity and excess weight. In New Zealand (NZ) more than 200,000 people have diabetes, with an incidence amongst the Maori and Pacific population three times greater than other NZ ethnic groups. Obesity is also more prevalent amongst this population, with each 5 kg/m2 higher BMI resulting in a 30% higher overall mortality.

Over the last 10 years bariatric surgery has been recognised as an effective strategy to treat both morbid obesity and T2DM. Indeed in a systematic review in 2004, by Buchwald et al, an overall T2DM remission rate of 76% was seen following bariatric surgery. In March 2011 the International Diabetic Federation released a position statement recognising bariatric surgery as an appropriate treatment option in those patients with T2DM and a body mass index (BMI)> OR = 35kg/m2 or BMI 30-35kg/m2 where medical treatment has failed.

SURGICAL PROCEDURES Laparoscopic Roux-en-Y gastric bypass (LRYGB): Currently the most commonly performed bariatric procedure worldwide. It combines a restrictive and malabsorptive (duodenal bypass) component, with a mean excess weight loss (EWL) of 61.6% and T2DM remission rate of 83.8% reported. Analysis of our own series identified a T2DM remission rate at 1 year of 88%.

Laparoscopic sleeve gastrectomy (LSG): A predominantly restrictive procedure (no bypass component), which was initially used as a staged approach to biliopancreatic diversion and duodenal switch (BPD-DS), has gained increasing popularity due its relatively lower technical complexity. In a recent systematic review a mean EWL of >45% (range 6.3 - 74.6%) was reported with an overall T2DM remission rate of 66%, which reduced to 59% where only those studies reporting 1 year outcomes were analysed. There is however a lack of medium and long term data and meta-analysis is currently not feasible in view of the high heterogeneity of studies and the lack of randomised controlled trials.

MECHANISM OF ACTION The mechanism of T2DM remission following these procedures remains unclear and may relate to the effects of reduced caloric intake or gut hormone effects in the proximal and distal intestine. Following LRYGB, the improvement in glycaemic control appears to occur before weight loss and may be explained by exclusion of the duodenum / proximal jejunum reducing insulin resistance or an enhanced hormonal response resulting from nutrients in the distal small bowel. Following LSG both hormonal changes and a hindgut theory have been proposed. In addition there is increasing evidence that changes in bone mineral density and body composition, with a reduction in body fat and lean tissue mass, and an increase in resting energy expenditure, may also occur following gastric bypass and other restrictive surgical procedures. It is unclear whether such changes correlate with the degree of comorbidity resolution after surgery.

CONCLUSION At the current time much of the data relating to LSG is based on non-randomised observational studies and it remains unclear whether the promising T2DM remission rates and excess weight loss reported will be sustainable in the long term. In the only published randomised trial, by Lee et al. from Taiwan, to compare T2DM remission rates at 1 year between LSG and gastric bypass in BMI < 35, a much higher remission rate of 93% was seen following gastric bypass compared with 47% following LSG. Given the potential technical benefits of LSG, there is an urgent need to compare the efficacy of this procedure with the more commonly performed LRYGB procedure, at a time when clinical equipoise remains, in order to determine the optimum approach to T2DM in the future.

Being tested
Laparoscopic Silastic Ring Roux-en-Y Gastric Bypass, Laparoscopic Sleeve gastrectomy
Keywords
Gastric bypass, Silastic ring gastric bypass, Roux-en-Y gastric bypass, Sleeve gastrectomy, Body composition analysis
Medical subject headings
Diabetes Mellitus, Type 2, Obesity

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Laparoscopic Silastic Ring Roux-en-Y Gastric BypassProcedure or surgery

    Also called Silastic ring Gastric bypass, Fobi pouch, RYGB, LRYGBP

    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.

  • Laparoscopic Sleeve gastrectomyProcedure or surgery

    Also called Vertical 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

Study groups in NCT01486680
Study groupRoleWhat they receive
Laparoscopic Silastic Ring Roux-en-Y Gastric BypassActive comparatorNot described
Receives: Procedure: Laparoscopic Silastic Ring Roux-en-Y Gastric Bypass
Laparoscopic Sleeve GastrectomyActive comparatorNot described
Receives: Procedure: Laparoscopic Sleeve gastrectomy

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Remission of type 2 diabetes mellitus/ glycaemic control

    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

    Measured: 5 years

Secondary outcomes (4)
  1. 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

    Measured: 5 years

  2. Peri/ post-operative morbidity and mortality

    For example haemorrhage, thromboembolic events, cardiorespiratory events, marginal ulceration, anastomotic / staple line leak, internal herniation, nutritional deficiencies and mortality

    Measured: 30-day, In-hospital, 1 year and 5 years

  3. Changes in body composition, resting energy expenditure and bone density

    Includes use of dual energy x-ray absorptiometry (DEXA)

    Measured: 1 year and 5 years

  4. Quality of Life

    Qualitative scores using Short Form-36 and Hospital and Anxiety depression scale

    Measured: 1 year and 5 years

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted6 Dec 2011 (estimated)
  2. Study startSep 2011
  3. Primary completionOct 2014
  4. Study completionOct 2019

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase N/A
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Parallel groups
Masking
Double blind
Who is masked
Participant, Outcomes assessor
Enrolment
106 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT01486680
Sponsor's protocol ID
NTY/11/07/082
Other IDs
ACTRN12611000751976
Status last verified
Sep 2021
First submitted
28 Nov 2011
Last updated
28 Sep 2021
Results posted
No
Data monitoring committee
No

Publications

  • Pullman JS, Plank LD, Nisbet S, Murphy R, Booth MWC. Seven-Year Results of a Randomized Trial Comparing Banded Roux-en-Y Gastric Bypass to Sleeve Gastrectomy for Type 2 Diabetes and Weight Loss. Obes Surg. 2023 Jul;33(7):1989-1996. doi: 10.1007/s11695-023-06635-x. Epub 2023 May 27.

    PubMed 37243915
  • 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.

    PubMed 33310883
  • 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.

    PubMed 28840525
  • 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.

    PubMed 27377635

Questions about this trial

What is this clinical trial studying?

A study testing Laparoscopic Silastic Ring Roux-en-Y Gastric Bypass and Laparoscopic Sleeve gastrectomy in people with Type 2 Diabetes Mellitus and Obesity, run by North Shore Hospital, New Zealand at 2 sites in New Zealand.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 4 inclusion and 11 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 28 Sep 2021. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 2 sites in New Zealand. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Remission of type 2 diabetes mellitus/ glycaemic control (time frame: 5 years). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT01486680, which also lists 4 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 28 Sep 2021.

Free account

Log in to keep searching

You’ve used your 3 free searches. AzTrials is free: log in or create a free account to keep searching clinical trials and save the ones you want to follow.

Create a free accountLog in