Integrative Care for Type 2 Diabetes
1 other identifier
interventional
148
1 country
2
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for phase_1 diabetes-mellitus-type-2
Started Jul 2016
Longer than P75 for phase_1 diabetes-mellitus-type-2
2 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
July 1, 2016
CompletedFirst Submitted
Initial submission to the registry
July 14, 2016
CompletedFirst Posted
Study publicly available on registry
July 26, 2016
CompletedPrimary Completion
Last participant's last visit for primary outcome
December 1, 2018
CompletedStudy Completion
Last participant's last visit for all outcomes
July 1, 2019
CompletedJuly 26, 2016
July 1, 2016
2.4 years
July 14, 2016
July 21, 2016
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
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 Outcomes (22)
Incidence of metabolic syndrome
2 year
Weight (as part of BMI)
2 year
Height (as part of BMI)
2 year
Waist circumference (as part of metabolic syndrome)
2 year
Fasting blood glucose
2 year
- +17 more secondary outcomes
Study Arms (2)
Control (Conventional) Arm
ACTIVE COMPARATORTreatment 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.
Integrative (Naturopathic + Conventional) Arm
ACTIVE COMPARATORIn 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.
Interventions
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
Eligibility Criteria
You may qualify if:
- 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
You may not qualify if:
- 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)
- 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
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (2)
Wise Elephant Family Health Team
Brampton, Ontario, L6V 4H4, Canada
The Canadian College of Naturopathic Medicine
Toronto, Ontario, M2K 1E2, Canada
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Ellen Wong, ND
The Canadian College of Naturopathic Medicine
Central Study Contacts
Study Design
- Study Type
- interventional
- Phase
- phase 1
- Allocation
- RANDOMIZED
- Masking
- NONE
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- Co Principal Investigator
Study Record Dates
First Submitted
July 14, 2016
First Posted
July 26, 2016
Study Start
July 1, 2016
Primary Completion
December 1, 2018
Study Completion
July 1, 2019
Last Updated
July 26, 2016
Record last verified: 2016-07
Data Sharing
- IPD Sharing
- Will not share