Bariatric Surgery Candidate, Obesity, Type2 Diabetes Mellitus
Conditions
Keywords
Bariatric surgery, Obesity, Type 2 Diabetes Mellitus, Indigenous Population, Randomized Control Trial, Glycoslyated Hemoglobin A1C, Anthropometric measurements, Medication Use
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.
Interventions
PROCEDUREFast-Track to Bariatric Surgery
30 participants from the urban Indigenous community who have Type 2 diabetes and are candidates for bariatric surgery at the Centre for Metabolic and Bariatric Surgery will be randomized to the fast-track to bariatric surgery group.
Sponsors
University of Manitoba
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
SINGLE (Outcomes Assessor)
Masking description
Each study participant will be assigned a unique study identification number (study ID). All information/data regarding the participant will be collected using the Study ID. In this way, data analyses by the outcomes assessor will be blinded.
Intervention model description
Patients consenting to participate will be randomized to one of two groups: (1) fast-track to bariatric surgery, or (2) Best diabetic care under the guidance of an endocrinologist for one year. Note: participants in the best diabetic care group will have the option to undergo bariatric surgery after one year if desired.
Eligibility
Sex/Gender
ALL
Age
18 Years to 55 Years
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Change in Fasting Blood Glucose | Baseline,3, 6, 9, and 12 months for all patients | Change from baseline fasting blood glucose level at 3, 6, 9, and 12 months |
| Change in Glycosylated Hemoglobin (HbA1c) | Baseline,3, 6, 9, and 12 months for all patients | Change from baseline Glycosylated Hemoglobin (HbA1c) at 3, 6, 9, and 12 months |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Change in the Percentage Change in Blood Pressure | Baseline, at 3, 6, 9, and 12 months for all patients | Change in Blood Pressure (percentage of initial pre-surgery blood pressure) at 3, 6, 9, and 12 months |
| Change in Diabetic Medication | Baseline,3, 6, 9, and 12 months for all patients | Change from baseline in the number and dose of diabetic medication at 3, 6, 9, and 12 months |
| Change in Fasting Blood Lipids | Baseline, at 3, 6, 9, and 12 months for all patients | Change in total, LDL, HDL, and triacylglycerides from baseline at 3, 6, 9, and 12 months |
| Change in Waist Circumference | Baseline, at 3, 6, 9, and 12 months for all patients | Change in waist circumference (cm) from baseline at 3, 6, 9, and 12 months |
| Change in Mean Weight Loss | Baseline, at 3, 6, 9, and 12 months for all patients | Change from baseline in total amount of weight lost at 3, 6, 9, and 12 months |
Contacts
Primary ContactKrista M Hardy, MD
Backup ContactKathleen M Clouston, PhD
Outcome results
None listed