Diabetes Mellitus, Type 2
Conditions
Keywords
Uncontrolled Type 2 Diabetes, HbA1c >7.0%
Brief summary
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.
Interventions
OTHERNaturopathic Care
Naturopathic diabetes care will be selected from a pre-approved menu. Participants' other health concerns will be addressed at naturopathic doctors' discretion
OTHERUsual (Conventional) Care
2016 Canadian Diabetes Clinical Practice Guidelines (self-management, blood-glucose-lowering, vascular protection, pharmacotherapy) will be implemented
Sponsors
The Canadian College of Naturopathic Medicine
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
21 Years to 75 Years
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Clinically meaningful reduction of HbA1c above and beyond that of control arm | 1 year | 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 |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Weight (as part of BMI) | 2 year | Kg |
| Height (as part of BMI) | 2 year | meters |
| Waist circumference (as part of metabolic syndrome) | 2 year | inches |
| Fasting blood glucose | 2 year | Fasting glucose (FG), biomarker associated with diabetes |
| Glycated hemoglobin (HbA1c) | 2 year | Biomarker associated with diabetes |
| Blood pressure (BP) | 2 year | Systolic and diastolic blood pressure, seated, resting |
| Total cholesterol (TC) (blood) | 2 year | Biomarkers associated with cholesterol & cardiovascular risk |
| High-density lipoprotein (HDL-C) (blood) | 2 year | Biomarkers associated with cholesterol & cardiovascular risk |
| Low-density lipoprotein (LDL-C) (blood) | 2 year | Biomarkers associated with cholesterol & cardiovascular risk |
| Triglycerides (TG))(blood) | 2 year | Biomarkers associated with cholesterol & cardiovascular risk |
| Incidence of metabolic syndrome | 2 year | — |
| Incidence of smoking | 2 year | Modifiable risk factors for cardiovascular disease |
| Incidence of obesity | 2 year | Modifiable risk factors for cardiovascular disease, BMI equal to or greater than 30.0 kg/m2 |
| Incidence of depression (PHQ-9) | 2 year | Depression as defined by the PHQ-9 |
| Impact on stress, anxiety, quality of life | 2 year | ADDQol |
| Impact on anxiety | 2 year | GAD 7 |
| DES | 2 year | Impact on quality of life |
| SF-12 | 2 year | Impact on quality of life |
| Compliance/adherence with treatment prescriptions including changes in lifestyle, diet, exercise, and nutraceutical supplementation | 2 year | Diet and physical activity tracker |
| Compliance/adherence with pharmaceutical prescriptions using a medication adherence questionnaire | 2 year | MMAQ |
| Adverse Events | 2 year | — |
| High-sensitivity C-reactive protein (hs-CRP) | 2 year | Biomarker associated with cardiovascular risk |
Countries
Canada
Contacts
Primary ContactEllen Wong, ND
Backup ContactKieran Cooley, ND
Outcome results
None listed