NCT01486680

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
106

participants targeted

Target at P50-P75 for not_applicable type-2-diabetes-mellitus

Timeline
Completed

Started Sep 2011

Longer than P75 for not_applicable type-2-diabetes-mellitus

Geographic Reach
1 country

2 active sites

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

September 1, 2011

Completed
3 months until next milestone

First Submitted

Initial submission to the registry

November 28, 2011

Completed
8 days until next milestone

First Posted

Study publicly available on registry

December 6, 2011

Completed
2.8 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

October 1, 2014

Completed
5 years until next milestone

Study Completion

Last participant's last visit for all outcomes

October 1, 2019

Completed
Last Updated

September 28, 2021

Status Verified

September 1, 2021

Enrollment Period

3.1 years

First QC Date

November 28, 2011

Last Update Submit

September 22, 2021

Conditions

Type 2 Diabetes MellitusObesity

Keywords

Gastric bypassSilastic ring gastric bypassRoux-en-Y gastric bypassSleeve gastrectomyBody composition analysis

Outcome Measures

Primary Outcomes (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

    5 years

Secondary Outcomes (4)

  • Comorbidity resolution

    5 years

  • Peri/ post-operative morbidity and mortality

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

  • Changes in body composition, resting energy expenditure and bone density

    1 year and 5 years

  • Quality of Life

    1 year and 5 years

Other Outcomes (1)

  • Weight loss (excess weight loss and actual weight loss)

    5 years

Study Arms (2)

Laparoscopic Silastic Ring Roux-en-Y Gastric Bypass

ACTIVE COMPARATOR
Procedure: Laparoscopic Silastic Ring Roux-en-Y Gastric Bypass

Laparoscopic Sleeve Gastrectomy

ACTIVE COMPARATOR
Procedure: Laparoscopic Sleeve gastrectomy

Interventions

Laparoscopic Silastic Ring Roux-en-Y Gastric BypassPROCEDURE

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.

Also known as: Silastic ring Gastric bypass, Fobi pouch, RYGB, LRYGBP, LRYGB, GBP, SR gastric bypass
Laparoscopic Silastic Ring Roux-en-Y Gastric Bypass
Laparoscopic Sleeve gastrectomyPROCEDURE

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

Also known as: Vertical sleeve gastrectomy
Laparoscopic Sleeve Gastrectomy

Eligibility Criteria

Age20 Years - 50 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64)

You may qualify if:

  • 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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (2)

North Shore Hospital

Auckland, 0622, New Zealand

Location

University of Auckland

Auckland, New Zealand

Location

Related Publications (4)

  • 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.

    PMID: 37243915DERIVED

  • 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.

    PMID: 33310883DERIVED

  • 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.

    PMID: 28840525DERIVED

  • 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.

    PMID: 27377635DERIVED

MeSH Terms

Conditions

Diabetes Mellitus, Type 2Obesity

Condition Hierarchy (Ancestors)

Diabetes MellitusGlucose Metabolism DisordersMetabolic DiseasesNutritional and Metabolic DiseasesEndocrine System DiseasesOverweightOvernutritionNutrition DisordersBody WeightSigns and SymptomsPathological Conditions, Signs and Symptoms

Study Officials

  • Michael Booth, MBA FRACS

    North Shore Hospital, Auckland, NEW ZEALAND

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
DOUBLE
Who Masked
PARTICIPANT, OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Consultant Bariatric, Upper GI and General Surgeon

Study Record Dates

First Submitted

November 28, 2011

First Posted

December 6, 2011

Study Start

September 1, 2011

Primary Completion

October 1, 2014

Study Completion

October 1, 2019

Last Updated

September 28, 2021

Record last verified: 2021-09

Locations

NZ(2)