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

This study is currently recruiting participants. (see Contacts and Locations)
Verified December 2011 by North Shore Hospital, New Zealand
Sponsor:
Information provided by (Responsible Party):
Dr. Michael Booth, North Shore Hospital, New Zealand
ClinicalTrials.gov Identifier:
NCT01486680
First received: November 28, 2011
Last updated: December 4, 2011
Last verified: December 2011
  Purpose

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.


Condition Intervention
Type 2 Diabetes Mellitus
Obesity
Procedure: Laparoscopic Silastic Ring Roux-en-Y Gastric Bypass
Procedure: Laparoscopic Sleeve gastrectomy

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Outcomes Assessor)
Primary Purpose: Treatment
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

Resource links provided by NLM:


Further study details as provided by North Shore Hospital, New Zealand:

Primary Outcome Measures:
  • Remission of type 2 diabetes mellitus [ Time Frame: 5 years ] [ Designated as safety issue: No ]
    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


Secondary Outcome Measures:
  • Weight loss (excess weight loss and actual weight loss) [ Time Frame: 5 years ] [ Designated as safety issue: No ]
  • Comorbidity resolution [ Time Frame: 5 years ] [ Designated as safety issue: No ]
    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

  • Peri/ post-operative morbidity and mortality [ Time Frame: 30-day, In-hospital, 1 year and 5 years ] [ Designated as safety issue: Yes ]
    For example haemorrhage, thromboembolic events, cardiorespiratory events, marginal ulceration, anastomotic / staple line leak, internal herniation, nutritional deficiencies and mortality

  • Changes in body composition, resting energy expenditure and bone density [ Time Frame: 1 year and 5 years ] [ Designated as safety issue: No ]
    Includes use of dual energy x-ray absorptiometry (DEXA)

  • Quality of Life [ Time Frame: 1 year and 5 years ] [ Designated as safety issue: No ]
    Using Short Form-36 and Hospital and Anxiety depression scale


Estimated Enrollment: 106
Study Start Date: September 2011
Estimated Study Completion Date: October 2018
Estimated Primary Completion Date: October 2013 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Active Comparator: Laparoscopic Silastic Ring Roux-en-Y Gastric Bypass Procedure: 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.
Other Names:
  • Silastic ring Gastric bypass
  • Fobi pouch
  • RYGB
  • LRYGBP
  • LRYGB
  • GBP
  • SR gastric bypass
Active Comparator: Laparoscopic Sleeve Gastrectomy Procedure: 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
Other Name: Vertical sleeve gastrectomy

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.

  Eligibility

Ages Eligible for Study:   20 Years to 50 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   Yes
Criteria

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

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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01486680

Contacts
Contact: Michael Booth, MBA FRACS michael.booth@waitematadhb.govt.nz
Contact: Michael G Clarke, MD FRCS mgclarkey@doctors.org.uk

Locations
New Zealand
North Shore Hospital Recruiting
Auckland, New Zealand, 0622
Contact: Michael Booth, MBA FRACS       michael.booth@waitematadhb.govt.nz   
Contact: Michael Clarke, MD FRCS       mgclarkey@doctors.org.uk   
Principal Investigator: Michael Booth, FRACS         
Sub-Investigator: Michael G Clarke, MD FRCS         
Sub-Investigator: Hisham Hammodat, FRACS         
Sub-Investigator: Nicholas Evennett, MD MBChB         
Sub-Investigator: David Kim, MBChB         
Sub-Investigator: Rick Cutfield, FRACP         
University of Auckland Recruiting
Auckland, New Zealand
Contact: Rinki Murphy, PhD FRACP       r.murphy@auckland.ac.nz   
Contact: Lindsay Plank, MSc DPhil       l.plank@auckland.ac.nz   
Principal Investigator: Rinki Murphy, PhD FRACP         
Sub-Investigator: Lindsay Plank, MSc DPhil         
Sponsors and Collaborators
North Shore Hospital, New Zealand
Investigators
Principal Investigator: Michael Booth, MBA FRACS North Shore Hospital, Auckland, New Zealand
  More Information

No publications provided

Responsible Party: Dr. Michael Booth, Consultant Bariatric, Upper GI and General Surgeon, North Shore Hospital, New Zealand
ClinicalTrials.gov Identifier: NCT01486680     History of Changes
Other Study ID Numbers: NTY/11/07/082, ACTRN12611000751976
Study First Received: November 28, 2011
Last Updated: December 4, 2011
Health Authority: New Zealand: Health and Disability Ethics Committees

Keywords provided by North Shore Hospital, New Zealand:
Gastric bypass
Silastic ring gastric bypass
Roux-en-Y gastric bypass
Sleeve gastrectomy
Body composition analysis

Additional relevant MeSH terms:
Diabetes Mellitus
Diabetes Mellitus, Type 2
Obesity
Glucose Metabolism Disorders
Metabolic Diseases
Endocrine System Diseases
Overnutrition
Nutrition Disorders
Overweight
Body Weight
Signs and Symptoms

ClinicalTrials.gov processed this record on August 28, 2014