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A two year, two arm pragmatic trial to investigate the integration of naturopathic care with conventional medical care to provide additional benefit beyond that of conventional medical care alone in achieving adequate control of diabetes.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Control (Conventional) Arm | Active Comparator | Treatment of Type 2 Diabetes according to the Canadian Diabetes Association guidelines. Participants' other health concerns to be addressed as per usual care by practitioners at Wise-Elephant Family Health Team. |
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| Integrative (Naturopathic + Conventional) Arm | Active Comparator | In addition to conventional care, participants will receive free naturopathic care at Brampton Naturopathic Teaching Clinic (located within the Brampton Civic Hospital). Senior student clinicians will provide care under the direct supervision of licensed naturopathic doctors. A naturopathic menu of treatment options have been designed to reflect naturopathic practice and vetted by 3 licensed naturopathic doctors and experts in the field. Participants' other health concerns will be addressed as per naturopathic doctors' discretion. |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Naturopathic Care | Other | Naturopathic diabetes care will be selected from a pre-approved menu. Participants' other health concerns will be addressed at naturopathic doctors' discretion |
| Measure | Description | Time Frame |
|---|---|---|
| Clinically meaningful reduction of HbA1c above and beyond that of control arm | To assess the integration of naturopathic care to conventional medical care in obtaining a clinically meaningful reduction of HbA1c (equal or > 0.5%) above and beyond reduction of HbA1c in the control group of phase 1 at 52 week for participants from Wise Elephant Family Health Team (WE-FHT) with type 2 diabetes | 1 year |
| Measure | Description | Time Frame |
|---|---|---|
| Incidence of metabolic syndrome | 2 year | |
| Weight (as part of BMI) | Kg | 2 year |
| Height (as part of BMI) |
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Inclusion Criteria:
Exclusion Criteria:
Lacking capacity for consent
Pregnancy or an intention to become pregnant in the following two years
Breastfeeding
History of myocardial infarction within the past 6 months
Chronic kidney (eGFR <30 mL/min) or liver disease
Actively receiving care from a complex care diabetes clinic
History of severe hypoglycemia in the last year resulting in hospital emergency care [where hypoglycemia is defined to be: 1) development of autonomic or neuroglycopenic symptoms, 2) low plasma glucose level (<4.0mmol/L for patients treated with insulin or an insulin secretagogue) and 3) symptoms responding to the administration of carbohydrate] or hypoglycemia unawareness
Current bolus or pre-mixed insulin treatment
Limited life expectancy (< 6 months)
High level of functional dependency (inability to perform common activities of daily living)
In participants aged 65yoa to 75yoa, the following also serve as exclusion criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Ellen Wong, ND | Contact | 416-498-1255 | 303 | ewong@ccnm.edu |
| Kieran Cooley, ND | Contact | 416-498-1255 | 324 | kcooley@ccnm.edu |
| Name | Affiliation | Role |
|---|---|---|
| Ellen Wong, ND | The Canadian College of Naturopathic Medicine | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Wise Elephant Family Health Team | Brampton | Ontario | L6V 4H4 | Canada |
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| ID | Term |
|---|---|
| D003924 | Diabetes Mellitus, Type 2 |
| ID | Term |
|---|---|
| D003920 | Diabetes Mellitus |
| D044882 | Glucose Metabolism Disorders |
| D008659 | Metabolic Diseases |
| D009750 | Nutritional and Metabolic Diseases |
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| ID | Term |
|---|---|
| D003226 | Congresses as Topic |
| ID | Term |
|---|---|
| D009938 | Organizations |
| D004472 | Health Care Economics and Organizations |
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| Usual (Conventional) Care | Other | 2016 Canadian Diabetes Clinical Practice Guidelines (self-management, blood-glucose-lowering, vascular protection, pharmacotherapy) will be implemented |
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meters |
| 2 year |
| Waist circumference (as part of metabolic syndrome) | inches | 2 year |
| Fasting blood glucose | Fasting glucose (FG), biomarker associated with diabetes | 2 year |
| Glycated hemoglobin (HbA1c) | Biomarker associated with diabetes | 2 year |
| Blood pressure (BP) | Systolic and diastolic blood pressure, seated, resting | 2 year |
| Total cholesterol (TC) (blood) | Biomarkers associated with cholesterol & cardiovascular risk | 2 year |
| High-density lipoprotein (HDL-C) (blood) | Biomarkers associated with cholesterol & cardiovascular risk | 2 year |
| Low-density lipoprotein (LDL-C) (blood) | Biomarkers associated with cholesterol & cardiovascular risk | 2 year |
| Triglycerides (TG))(blood) | Biomarkers associated with cholesterol & cardiovascular risk | 2 year |
| High-sensitivity C-reactive protein (hs-CRP) | Biomarker associated with cardiovascular risk | 2 year |
| Incidence of smoking | Modifiable risk factors for cardiovascular disease | 2 year |
| Incidence of obesity | Modifiable risk factors for cardiovascular disease, BMI equal to or greater than 30.0 kg/m2 | 2 year |
| Incidence of depression (PHQ-9) | Depression as defined by the PHQ-9 | 2 year |
| Impact on stress, anxiety, quality of life | ADDQol | 2 year |
| Impact on anxiety | GAD 7 | 2 year |
| DES | Impact on quality of life | 2 year |
| SF-12 | Impact on quality of life | 2 year |
| Compliance/adherence with treatment prescriptions including changes in lifestyle, diet, exercise, and nutraceutical supplementation | Diet and physical activity tracker | 2 year |
| Compliance/adherence with pharmaceutical prescriptions using a medication adherence questionnaire | MMAQ | 2 year |
| Adverse Events | 2 year |
| The Canadian College of Naturopathic Medicine | Toronto | Ontario | M2K 1E2 | Canada |
| D004700 | Endocrine System Diseases |