The Metabolic Impact of Bariatric Surgery Compared to Best Diabetic Care on Manitoba's Urban Indigenous Population

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.

Study Overview

• Status: Unknown
• Conditions: Obesity; Bariatric Surgery Candidate; Type2 Diabetes Mellitus
• Intervention / Treatment: Procedure: Fast-Track to Bariatric Surgery

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.

• Study Type: Interventional
• Enrollment (Anticipated): 60
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Krista M Hardy, MD; Phone Number: 204-237-2574; Email: khardy@sbgh.mb.ca
• Study Contact Backup: Name: Kathleen M Clouston, PhD; Phone Number: 204-258-1479; Email: kclouston@sbgh.mb.ca

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 55 years (Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Single

Number of Arms

3

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Active Comparator: Fast-Track to Bariatric Surgery; 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.	Procedure: Fast-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.
No Intervention: Best Diabetic Care Group; 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).
No Intervention: Retrospective Cohort; 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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Change in Fasting Blood Glucose	Change from baseline fasting blood glucose level at 3, 6, 9, and 12 months	Baseline,3, 6, 9, and 12 months for all patients
Change in Glycosylated Hemoglobin (HbA1c)	Change from baseline Glycosylated Hemoglobin (HbA1c) at 3, 6, 9, and 12 months	Baseline,3, 6, 9, and 12 months for all patients

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Change in Diabetic Medication	Change from baseline in the number and dose of diabetic medication at 3, 6, 9, and 12 months	Baseline,3, 6, 9, and 12 months for all patients
Change in Mean Weight Loss	Change from baseline in total amount of weight lost at 3, 6, 9, and 12 months	Baseline, at 3, 6, 9, and 12 months for all patients
Change in the Percentage Change in Blood Pressure	Change in Blood Pressure (percentage of initial pre-surgery blood pressure) at 3, 6, 9, and 12 months	Baseline, at 3, 6, 9, and 12 months for all patients
Change in Waist Circumference	Change in waist circumference (cm) from baseline at 3, 6, 9, and 12 months	Baseline, at 3, 6, 9, and 12 months for all patients
Change in Fasting Blood Lipids	Change in total, LDL, HDL, and triacylglycerides from baseline at 3, 6, 9, and 12 months	Baseline, at 3, 6, 9, and 12 months for all patients

Collaborators and Investigators

• Sponsor: University of Manitoba
• Investigators: Principal Investigator: Krista M Hardy, MD, University of Manitoba; Dept of Surgery

Study record dates

Study Major Dates

• Study Start (Anticipated): July 1, 2020
• Primary Completion (Anticipated): December 31, 2021
• Study Completion (Anticipated): December 31, 2022

Study Registration Dates

• First Submitted: September 29, 2017
• First Submitted That Met QC Criteria: September 29, 2017
• First Posted (Actual): October 4, 2017

Study Record Updates

• Last Update Posted (Actual): April 6, 2020
• Last Update Submitted That Met QC Criteria: April 3, 2020
• Last Verified: April 1, 2020

More Information

Terms related to this study

• Keywords: Obesity; Bariatric surgery; Type 2 Diabetes Mellitus; Randomized Control Trial; Indigenous Population; Glycoslyated Hemoglobin A1C; Anthropometric measurements; Medication Use
• Additional Relevant MeSH Terms: Glucose Metabolism Disorders; Metabolic Diseases; Endocrine System Diseases; Diabetes Mellitus; Diabetes Mellitus, Type 2
• Other Study ID Numbers: HS20519 (B2017:023)

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: UNDECIDED
• IPD Plan Description: Will be carried out according to University of Manitoba and Winnipeg Regional Health Authority applicable policies.

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No