Type2 Diabetes MellitusNCT03301545
The Metabolic Impact of Bariatric Surgery Compared to Best Diabetic Care on Manitoba's Urban Indigenous Population
A study testing Fast-Track to Bariatric Surgery in people with Type2 Diabetes Mellitus and Obesity, run by University of Manitoba.
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. Read more about this study
- Who is it for?
- Ages 18 to 55 years
- Conditions the study is for
- Type2 Diabetes Mellitus, Obesity, Bariatric Surgery Candidate
- What is being tested?
- Fast-Track to Bariatric Surgery
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 60 participants
- Where
- No sites listed yet
- Study dates
- 1 Jul 2020to 31 Dec 2022
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 55 years
- All sexes
- No healthy volunteers
- Adult
Who may be able to join
- 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
Who cannot join
- 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
Trial locations and contacts
No sites are listed yet.
About this study
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.
Read the 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.
- Being tested
- Fast-Track to Bariatric Surgery
- Keywords
- Bariatric surgery, Obesity, Type 2 Diabetes Mellitus, Indigenous Population, Randomized Control Trial, Glycoslyated Hemoglobin A1C, Anthropometric measurements, Medication Use
- Medical subject headings
- Obesity, Diabetes Mellitus, Type 2
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Fast-Track to Bariatric SurgeryProcedure or 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.
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: 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. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in Fasting Blood Glucose
Change from baseline fasting blood glucose level at 3, 6, 9, and 12 months
Measured: 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
Measured: Baseline,3, 6, 9, and 12 months for all patients
Secondary outcomes (5)
Change in Diabetic Medication
Change from baseline in the number and dose of diabetic medication at 3, 6, 9, and 12 months
Measured: 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
Measured: 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
Measured: 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
Measured: 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
Measured: Baseline, at 3, 6, 9, and 12 months for all patients
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted4 Oct 2017
- Study start1 Jul 2020 (estimated)
- Primary completion31 Dec 2021 (estimated)
- Study completion31 Dec 2022 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Type2 Diabetes MellitusStudies of the same condition, open and under way.
- More trials run by University of ManitobaThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- 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.
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 60 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University of Manitoba
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Krista M Hardy, MD, Principal investigator, University of Manitoba; Dept of Surgery
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03301545
- Sponsor's protocol ID
- HS20519 (B2017:023)
- Status last verified
- Apr 2020
- First submitted
- 29 Sep 2017
- Last updated
- 6 Apr 2020
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided: Will be carried out according to University of Manitoba and Winnipeg Regional Health Authority applicable policies.
Study at a glance
From the registry record, last updated by the sponsor on 6 Apr 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Metabolic Impact of Bariatric Surgery Compared to Best Diabetic Care on Manitoba's Urban Indigenous Population
- ClinicalTrials.gov ID
- NCT03301545
- Acronym / sponsor ID
- HS20519 (B2017:023)
- Keywords
- Bariatric surgery, Obesity, Type 2 Diabetes Mellitus, Indigenous Population, Randomized Control Trial, Glycoslyated Hemoglobin A1C, Anthropometric measurements, Medication Use
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 60 participants (estimated)
- Lead sponsor
- University of ManitobaUniversity, hospital or other
- Study start
- 1 Jul 2020 (estimated)
- Primary completion
- 31 Dec 2021 (estimated)
- Study completion
- 31 Dec 2022 (estimated)
- First posted
- 4 Oct 2017 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 3
- Model description
- 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.
| Arm | Type | Receives |
|---|---|---|
| Fast-Track to Bariatric Surgery | Active comparator | Procedure: Fast-Track to Bariatric SurgeryPatients 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. |
| 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. |
Who may qualify
- Ages
- 18 to 55 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (6 listed)
- 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)
Key exclusion criteria (6 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Fast-Track to Bariatric Surgery30 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. | Procedure or surgery | Fast-Track to Bariatric Surgery |
Primary outcome
Change in Fasting Blood Glucose
Time frame: Baseline,3, 6, 9, and 12 months for all patients
Change from baseline fasting blood glucose level at 3, 6, 9, and 12 months
Change in Glycosylated Hemoglobin (HbA1c)
Time frame: Baseline,3, 6, 9, and 12 months for all patients
Change from baseline Glycosylated Hemoglobin (HbA1c) at 3, 6, 9, and 12 months
5 secondary outcomes
Change in Diabetic Medication
Time frame: Baseline,3, 6, 9, and 12 months for all patients
Change in Mean Weight Loss
Time frame: Baseline, at 3, 6, 9, and 12 months for all patients
Change in the Percentage Change in Blood Pressure
Time frame: Baseline, at 3, 6, 9, and 12 months for all patients
Change in Waist Circumference
Time frame: Baseline, at 3, 6, 9, and 12 months for all patients
Change in Fasting Blood Lipids
Time frame: Baseline, at 3, 6, 9, and 12 months for all patients
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 6 Apr 2020.
- Individual participant dataSharing planned: Undecided. Will be carried out according to University of Manitoba and Winnipeg Regional Health Authority applicable policies.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Krista M Hardy, MD principal investigator
University of Manitoba; Dept of Surgery
Questions about this trial
What is this clinical trial studying?
A study testing Fast-Track to Bariatric Surgery in people with Type2 Diabetes Mellitus and Obesity, run by University of Manitoba.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 6 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 6 Apr 2020. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Krista M Hardy, MD (204-237-2574, khardy@sbgh.mb.ca), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change in Fasting Blood Glucose (time frame: Baseline,3, 6, 9, and 12 months for all patients). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 6 Apr 2020.