Integrative Care for Type 2 Diabetes

NCT ID: NCT02843724

Last Updated: 2016-07-26

Basic Information

• Recruitment Status: UNKNOWN
• Clinical Phase: PHASE1/PHASE2
• Total Enrollment: 148 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2016-07-31
• Study Completion Date: 2019-07-31

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.

Conditions

Diabetes Mellitus, Type 2

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

Control (Conventional) Arm

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.

Group Type: ACTIVE_COMPARATOR

Usual (Conventional) Care

Intervention Type: OTHER

2016 Canadian Diabetes Clinical Practice Guidelines (self-management, blood-glucose-lowering, vascular protection, pharmacotherapy) will be implemented

Integrative (Naturopathic + Conventional) Arm

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.

Group Type: ACTIVE_COMPARATOR

Naturopathic Care

Intervention Type: OTHER

Naturopathic diabetes care will be selected from a pre-approved menu. Participants' other health concerns will be addressed at naturopathic doctors' discretion

Usual (Conventional) Care

Intervention Type: OTHER

2016 Canadian Diabetes Clinical Practice Guidelines (self-management, blood-glucose-lowering, vascular protection, pharmacotherapy) will be implemented

Interventions

Naturopathic Care

Naturopathic diabetes care will be selected from a pre-approved menu. Participants' other health concerns will be addressed at naturopathic doctors' discretion

Intervention Type: OTHER

Usual (Conventional) Care

2016 Canadian Diabetes Clinical Practice Guidelines (self-management, blood-glucose-lowering, vascular protection, pharmacotherapy) will be implemented

Intervention Type: OTHER

Eligibility Criteria

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)

1. Recent MI or stroke (within last 6 months)

2. NYHA CHF Functional Capacity Stage III or above

3. NYHA CHF Objective Assessment Stage C or greater (http://www.heart.org/HEARTORG/Conditions/HeartFailure/AboutHeartFailure/Classes-of-Heart-Failure_UCM_306328_Article.jsp)

4. Planned revascularization procedure (PCI or coronary artery bypass graft) or coronary angiogram within 90 days after screening or randomization

• Minimum Eligible Age: 21 Years
• Maximum Eligible Age: 75 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

The Canadian College of Naturopathic Medicine

OTHER

Sponsor Role: lead

Responsible Party

Ellen Wong

Co Principal Investigator

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Ellen Wong, ND

Role: PRINCIPAL_INVESTIGATOR

The Canadian College of Naturopathic Medicine

Locations

Wise Elephant Family Health Team

Brampton, Ontario, Canada

The Canadian College of Naturopathic Medicine

Toronto, Ontario, Canada

Countries

Canada

Central Contacts

Ellen Wong, ND

Role: CONTACT

ewong@ccnm.edu

416-498-1255 ext. 303

Kieran Cooley, ND

Role: CONTACT

kcooley@ccnm.edu

416-498-1255 ext. 324

Facility Contacts

Sanjeev Goel, MD

Role: primary

(289) 323-0660

Other Identifiers

CanadianCNN

Identifier Type: -

Identifier Source: org_study_id