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

Obesity Clinical Trial

Official title:

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

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT03301545
• Other study ID #: HS20519 (B2017:023)
• Status: Not yet recruiting
• Phase: N/A
• Start date: July 1, 2020
• Est. completion date: December 31, 2022

Study information

• Verified date: April 2020
• Source: University of Manitoba
• Contact: Krista M Hardy, MD
• Phone: 204-237-2574
• Email: khardy[@]sbgh.mb.ca
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 60
• Est. completion date: December 31, 2022
• Est. primary completion date: December 31, 2021
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 55 Years

Eligibility

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

Related Conditions & MeSH terms

• Bariatric Surgery Candidate
• Diabetes Mellitus
• Diabetes Mellitus, Type 2
• Obesity
• Type2 Diabetes Mellitus

Intervention

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.

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
University of Manitoba

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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
Primary	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	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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