The Metabolic Impact of Bariatric Surgery Compared to Best Diabetic Care on Manitoba's Urban Indigenous Population
Overview
- Phase
- Not Applicable
- Intervention
- Not specified
- Conditions
- Type2 Diabetes Mellitus
- Sponsor
- University of Manitoba
- Enrollment
- 60
- Primary Endpoint
- Change in Glycosylated Hemoglobin (HbA1c)
- Last Updated
- 6 years ago
Overview
Brief Summary
Obesity and type 2 diabetes mellitus (T2DM) are major global health concerns as they commonly co-occur and are associated with significant morbidity, mortality, and health care expenditures. The Indigenous (First Nations, Metis and Inuit) population bears a disproportionate burden of T2DM in Canada. The prevalence of obesity among Indigenous individuals is approximately 31.2% compared to 18.6% for the non-Indigenous population. In 2011, 16.7% of Manitoba's population, or four times the Canadian average, identified as Indigenous. At the same time, prevalence of T2DM in Manitoba is on the rise. Bariatric surgery is an effective treatment modality for the improvement and resolution of T2DM in patients who are obese. We aim to compare the effectiveness of bariatric surgery with conventional medical treatment in treating metabolic diseases in Indigenous people; the findings of which will assist in future treatment and program planning. Our objective is to determine whether Manitoba's urban Indigenous population will achieve better diabetic control and improved rates of remission of T2DM with bariatric surgery compared to best diabetic medical care.
Detailed Description
Obesity and type 2 diabetes mellitus (T2DM) are major global health concerns as they commonly co-occur and are associated with significant morbidity, mortality, and health care expenditures. The Indigenous population bears a disproportionate burden of T2DM in Canada. The 2007/2008 Canadian Community Health Survey (Statistics Canada) reported the prevalence of obesity among Indigenous individuals is approximately 31.2% compared to 18.6% for the non-Indigenous population. In 2011, 16.7% of Manitoba's population, or four times the Canadian average, identified as Indigenous (Statistics Canada). At the same time, prevalence of T2DM in Manitoba is on the rise. Bariatric surgery is an effective treatment modality for the improvement and resolution of T2DM in patients who are obese. To date, there are no published studies comparing the effectiveness of bariatric surgery with conventional medical treatment in treating metabolic diseases in Indigenous people. Our objective is to determine whether Manitoba's urban Indigenous population will achieve better diabetic control and improved rates of remission of T2DM with bariatric surgery compared to best diabetic medical care (Manitoba Diabetes Care Recommendations, 2010; consistent with the Diabetes Canada and Clinical Practice Guidelines). Our primary outcome is best diabetic control at one-year post-intervention, as measured by fasting plasma glucose and hemaglobin A1c (HbA1c). Secondary outcomes will include changes in diabetic medication use, mean weight loss, and percentage changes in blood pressure, waist circumference measurement changes, and levels of fasting blood lipids (total cholesterol, HDL, LDL, and triglycerides). Additional funding to extend the study to include follow-up of study participants at five years post-treatment through accessing their medical charts and anonymized administrative data will be sought.
Investigators
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
Outcomes
Primary Outcomes
Change in Glycosylated Hemoglobin (HbA1c)
Time Frame: Baseline,3, 6, 9, and 12 months for all patients
Change from baseline Glycosylated Hemoglobin (HbA1c) at 3, 6, 9, and 12 months
Change in Fasting Blood Glucose
Time Frame: Baseline,3, 6, 9, and 12 months for all patients
Change from baseline fasting blood glucose level at 3, 6, 9, and 12 months
Secondary Outcomes
- Change in the Percentage Change in Blood Pressure(Baseline, at 3, 6, 9, and 12 months for all patients)
- Change in Waist Circumference(Baseline, at 3, 6, 9, and 12 months for all patients)
- Change in Fasting Blood Lipids(Baseline, at 3, 6, 9, and 12 months for all patients)
- Change in Diabetic Medication(Baseline,3, 6, 9, and 12 months for all patients)
- Change in Mean Weight Loss(Baseline, at 3, 6, 9, and 12 months for all patients)