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

NCT ID: NCT03301545

Last Updated: 2020-04-06

Basic Information

• Recruitment Status: UNKNOWN
• Clinical Phase: NA
• Total Enrollment: 60 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2020-07-01
• Study Completion Date: 2022-12-31

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.

Conditions

Type2 Diabetes Mellitus; Obesity; Bariatric Surgery Candidate

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: SINGLE

Study Groups

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.

Group Type: ACTIVE_COMPARATOR

Fast-Track to Bariatric Surgery

Intervention Type: PROCEDURE

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.

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).

Group Type: NO_INTERVENTION

No interventions assigned to this group

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.

Group Type: NO_INTERVENTION

No interventions assigned to this group

Interventions

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.

Intervention Type: PROCEDURE

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

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 55 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

University of Manitoba

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Krista M Hardy, MD

Role: PRINCIPAL_INVESTIGATOR

University of Manitoba; Dept of Surgery

Central Contacts

Krista M Hardy, MD

Role: CONTACT

khardy@sbgh.mb.ca

204-237-2574

Kathleen M Clouston, PhD

Role: CONTACT

kclouston@sbgh.mb.ca

204-258-1479

Other Identifiers

HS20519 (B2017:023)

Identifier Type: -

Identifier Source: org_study_id