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

NCT03301545 | Unknown

• 1 other identifier: HS20519 (B2017:023)
• Study Type: interventional
• Target: 60
• Locations: 0 countries
• Sites: N/A

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.

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

Outcome Measures

Primary Outcomes (2)

• 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 Outcomes (5)

• 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

• 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

Study Arms (3)

Fast-Track to Bariatric Surgery

ACTIVE COMPARATOR

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

Best Diabetic Care Group

NO INTERVENTION

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).

Retrospective Cohort

NO INTERVENTION

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.

Interventions

Fast-Track to Bariatric Surgery 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.

Fast-Track to Bariatric Surgery

Eligibility Criteria

• Age: 18 Years - 55 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

• Urban Indigenous patient
• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• University of Manitoba: lead

MeSH Terms

Conditions

Obesity; Diabetes Mellitus, Type 2

Condition Hierarchy (Ancestors)

Overweight; Overnutrition; Nutrition Disorders; Nutritional and Metabolic Diseases; Body Weight; Signs and Symptoms; Pathological Conditions, Signs and Symptoms; Diabetes Mellitus; Glucose Metabolism Disorders; Metabolic Diseases; Endocrine System Diseases

Study Officials

• Krista M Hardy, MD

  University of Manitoba; Dept of Surgery

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Krista M Hardy, MD

CONTACT

204-237-2574; khardy@sbgh.mb.ca

Kathleen M Clouston, PhD

CONTACT

204-258-1479; kclouston@sbgh.mb.ca

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Masking Details: 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.
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: 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.

Study Record Dates

• First Submitted: September 29, 2017
• First Posted: October 4, 2017
• Study Start: July 1, 2020
• Primary Completion: December 31, 2021
• Study Completion: December 31, 2022
• Last Updated: April 6, 2020

Record last verified: 2020-04