Integrative Care for Type 2 Diabetes

Study Overview
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Brief Summary
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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.

Official Title
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Integrative Care for Type 2 Diabetes: Evaluating the Impact of Naturopathic Adjunctive Care for Diabetic Patients of a Family Health Team

Conditions
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Diabetes Mellitus, Type 2

Intervention / Treatment
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* Other: Naturopathic Care
* Other: Usual (Conventional) Care


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Males or females, enrolled as a patient with WE-FHT Ages 21-75 years old Diagnosed with type 2 diabetes and not adequately controlled (HbA1c > 7.0mmol/L) Currently seeking care with a medical doctor, nurse practitioner and/or physician assistant Willingness to adhere to randomized treatment with availability for follow-up Ability to answer self- and interviewer- administered questions in English or have an English speaking caregiver who can aid in answering self- and interviewer- administered questions Ability to provide written informed consent or give informed consent through substitute decision maker Capacity to maintain a diary and log of treatments and recommendations given during study 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: Recent MI or stroke (within last 6 months) NYHA CHF Functional Capacity Stage III or above NYHA CHF Objective Assessment Stage C or greater (http://www.heart.org/HEARTORG/Conditions/HeartFailure/AboutHeartFailure/Classes-of-Heart-Failure_UCM_306328_Article.jsp) Planned revascularization procedure (PCI or coronary artery bypass graft) or coronary angiogram within 90 days after screening or randomization

Ages Eligible for Study
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Minimum Age: 21 Years
Maximum Age: 75 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: Control (Conventional) Arm<br>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. | Other: Usual (Conventional) Care<br>* 2016 Canadian Diabetes Clinical Practice Guidelines (self-management, blood-glucose-lowering, vascular protection, pharmacotherapy) will be implemented<br>|
| Active Comparator: Integrative (Naturopathic + Conventional) Arm<br>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. | Other: Naturopathic Care<br>* Naturopathic diabetes care will be selected from a pre-approved menu. Participants' other health concerns will be addressed at naturopathic doctors' discretion<br>Other: Usual (Conventional) Care<br>* 2016 Canadian Diabetes Clinical Practice Guidelines (self-management, blood-glucose-lowering, vascular protection, pharmacotherapy) will be implemented<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | 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 | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Incidence of metabolic syndrome |  | 2 year | 
| Weight (as part of BMI) | Kg | 2 year | 
| Height (as part of BMI) | 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 | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Uncontrolled Type 2 Diabetes, HbA1c >7.0%