Status:
COMPLETED
Silastic Ring Gastric Bypass Versus Sleeve Gastrectomy for Type 2 Diabetes Mellitus in Obese Patients
Lead Sponsor:
North Shore Hospital, New Zealand
Conditions:
Type 2 Diabetes Mellitus
Obesity
Eligibility:
All Genders
20-50 years
Phase:
NA
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 t...
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 (T2D...
Eligibility Criteria
Inclusion
- 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
- 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
Key Trial Info
Start Date :
September 1 2011
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
October 1 2019
Estimated Enrollment :
106 Patients enrolled
Trial Details
Trial ID
NCT01486680
Start Date
September 1 2011
End Date
October 1 2019
Last Update
September 28 2021
Active Locations (2)
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1
North Shore Hospital
Auckland, New Zealand, 0622
2
University of Auckland
Auckland, New Zealand