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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

Type 2 diabetes remission in obese patients: A randomised controlled study of laparoscopic Roux-en-Y gastric bypass versus laparoscopic sleeve gastrectomy

Status
Recruiting
Phases
Unknown
Study type
Interventional
Source
ANZCTR
Registry ID
ACTRN12611000751976
Enrollment
106
Registered
2011-07-18
Start date
2011-09-06
Completion date
2014-09-03
Last updated
2020-01-13

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

None listed

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.

Interventions

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.

Sponsors

Waitemata District Health Board
Lead SponsorHospital

Study design

Allocation
Randomised controlled trial
Intervention model
Parallel
Primary purpose
Treatment
Masking
Blinded (masking used)

Eligibility

Sex/Gender
All
Age
20 Years to 50 Years
Healthy volunteers
No

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

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

Outcome results

None listed

Source: ANZCTR · Data processed: Mar 1, 2026