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Clinical Trial Details — Status: Not yet recruiting

Administrative data

NCT number NCT03301545
Other study ID # HS20519 (B2017:023)
Secondary ID
Status Not yet recruiting
Phase N/A
First received
Last updated
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
Health authority
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

Study Design


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
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