The Metabolic Impact of Bariatric Surgery Compared to Best Diabetic Care on Manitoba's Urban Indigenous Population
Type2 Diabetes Mellitus, Obesity, Bariatric Surgery Candidate
About this trial
This is an interventional treatment trial for Type2 Diabetes Mellitus focused on measuring Bariatric surgery, Obesity, Type 2 Diabetes Mellitus, Indigenous Population, Randomized Control Trial, Glycoslyated Hemoglobin A1C, Anthropometric measurements, Medication Use
Eligibility Criteria
Inclusion Criteria:
- Urban Indigenous patient
- 18 to 55 years of age
- male of female
- Body Mass Index = or > 35 to 55 Kg/m2
- Confirmed diagnosis of Type II diabetes mellitus (HbA1c of 7.0% for at least one year)
- Referred and accepted as into the Centre for Metabolic and Bariatric Surgery Program
Exclusion Criteria:
- Currently a smoker
- Body Mass Index above 55 Kg/m2
- Diagnosed with Type I diabetes mellitus
- Have had previous bariatric surgery
- Have contraindications to laparoscopic and/or bariatric surgery
- Rural patients; due to lack of rural Indigenous community-based support necessary for bariatric surgery
Sites / Locations
Arms of the Study
Arm 1
Arm 2
Arm 3
Active Comparator
No Intervention
No Intervention
Fast-Track to Bariatric Surgery
Best Diabetic Care Group
Retrospective Cohort
Patients will undergo standard of care for bariatric surgery patients in Manitoba and receive preoperative evaluation by the Centre for Metabolic and Bariatric Surgery (CMBS) team of nurses, dietitians, psychologist, and kinesiologist. Patients must attend the standard appointments and achieve the personalized program goals to be approved for laparoscopic Roux-En-Y gastric bypass surgery. Once approved, one of four surgeons performs surgery (within 12 months of randomization). Patients are followed post-operatively (by surgeon) at 6 weeks, and at 6 and 12 months. Pharmacologic glycemic control will be determined by an endocrinologist as per a standardized post-operative protocol. Post-procedural multidisciplinary follow-up occurs based on established CMBS guidelines (phone call 1 week post-operatively and an appointment at 3 and 12 months). Patients receive surgery within the current publically funded bariatric surgery program; no additional direct costs incurred by the patients.
Patients will receive the best available medical practice for the treatment, education, and follow-up T2DM based on Manitoba Diabetes Care Recommendations and Diabetes Canada's clinical practice guidelines. Patients will have access to a general physician, endocrinologist, and a diabetes education nurse. An Endocrinologist will deliver the program to patients. Diabetes care, education and self-management support services will be provided by the Victoria General Hospital (VGH) Diabetes Education Centre; led by a registered nurse and dietitian. Patients will undergo individual diabetes management instruction which may include counseling on topics such as diet, exercise, smoking cessation, medications, diabetic complications, and blood sugar testing. Medical therapies, including pharmaceutical agents, will be determined on an individual basis as per standard protocol. There will be no direct patient-related medication costs (publicly funded).
A retrospective cohort of non-Indigenous bariatric surgery patients from the Centre for Metabolic and Bariatric Surgery Program will allow comparison with the intervention group. The cohort will be age and gender matched.