Clinical trial NCT03301545: The Metabolic Impact of Bariatric Surgery Compared to Best Diabetic Care on Manitoba's Urban Indigenous Population
Official title: The Metabolic Impact of Bariatric Surgery Compared to Best Diabetic Care on Manitoba's Urban Indigenous Population
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Type2 Diabetes Mellitus
Obesity
Bariatric Surgery Candidate
Keywords: Bariatric surgery
Obesity
Type 2 Diabetes Mellitus
Indigenous Population
Randomized Control Trial
Glycoslyated Hemoglobin A1C
Anthropometric measurements
Medication Use
Lead sponsor: University of Manitoba
Sponsor class: OTHER
First posted: 2017-10-04
Enrollment: 60
Sex: ALL
Minimum age (years): 18
Maximum age (years): 55
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
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.
Primary purpose: TREATMENT

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.

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

Primary outcomes:
measure: Change in Fasting Blood Glucose
timeFrame: Baseline,3, 6, 9, and 12 months for all patients
measure: Change in Glycosylated Hemoglobin (HbA1c)
timeFrame: Baseline,3, 6, 9, and 12 months for all patients
Secondary outcomes:
measure: Change in Diabetic Medication
timeFrame: Baseline,3, 6, 9, and 12 months for all patients
measure: Change in Mean Weight Loss
timeFrame: Baseline, at 3, 6, 9, and 12 months for all patients
measure: Change in the Percentage Change in Blood Pressure
timeFrame: Baseline, at 3, 6, 9, and 12 months for all patients
measure: Change in Waist Circumference
timeFrame: Baseline, at 3, 6, 9, and 12 months for all patients
measure: Change in Fasting Blood Lipids
timeFrame: Baseline, at 3, 6, 9, and 12 months for all patients
Other outcomes:
Locations:
Study officials:
affiliation: University of Manitoba; Dept of Surgery
name: Krista M Hardy, MD
role: PRINCIPAL_INVESTIGATOR
References: