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.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Enrollment
148
Naturopathic diabetes care will be selected from a pre-approved menu. Participants' other health concerns will be addressed at naturopathic doctors' discretion
2016 Canadian Diabetes Clinical Practice Guidelines (self-management, blood-glucose-lowering, vascular protection, pharmacotherapy) will be implemented
Wise Elephant Family Health Team
Brampton, Ontario, Canada
The Canadian College of Naturopathic Medicine
Toronto, Ontario, Canada
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
Time frame: 1 year
Incidence of metabolic syndrome
Time frame: 2 year
Weight (as part of BMI)
Kg
Time frame: 2 year
Height (as part of BMI)
meters
Time frame: 2 year
Waist circumference (as part of metabolic syndrome)
inches
Time frame: 2 year
Fasting blood glucose
Fasting glucose (FG), biomarker associated with diabetes
Time frame: 2 year
Glycated hemoglobin (HbA1c)
Biomarker associated with diabetes
Time frame: 2 year
Blood pressure (BP)
Systolic and diastolic blood pressure, seated, resting
Time frame: 2 year
Total cholesterol (TC) (blood)
Biomarkers associated with cholesterol \& cardiovascular risk
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Time frame: 2 year
High-density lipoprotein (HDL-C) (blood)
Biomarkers associated with cholesterol \& cardiovascular risk
Time frame: 2 year
Low-density lipoprotein (LDL-C) (blood)
Biomarkers associated with cholesterol \& cardiovascular risk
Time frame: 2 year
Triglycerides (TG))(blood)
Biomarkers associated with cholesterol \& cardiovascular risk
Time frame: 2 year
High-sensitivity C-reactive protein (hs-CRP)
Biomarker associated with cardiovascular risk
Time frame: 2 year
Incidence of smoking
Modifiable risk factors for cardiovascular disease
Time frame: 2 year
Incidence of obesity
Modifiable risk factors for cardiovascular disease, BMI equal to or greater than 30.0 kg/m2
Time frame: 2 year
Incidence of depression (PHQ-9)
Depression as defined by the PHQ-9
Time frame: 2 year
Impact on stress, anxiety, quality of life
ADDQol
Time frame: 2 year
Impact on anxiety
GAD 7
Time frame: 2 year
DES
Impact on quality of life
Time frame: 2 year
SF-12
Impact on quality of life
Time frame: 2 year
Compliance/adherence with treatment prescriptions including changes in lifestyle, diet, exercise, and nutraceutical supplementation
Diet and physical activity tracker
Time frame: 2 year
Compliance/adherence with pharmaceutical prescriptions using a medication adherence questionnaire
MMAQ
Time frame: 2 year
Adverse Events
Time frame: 2 year