Integrative Care for Type 2 Diabetes

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

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 Overview

• Status: Unknown
• Conditions: Diabetes Mellitus, Type 2
• Intervention / Treatment: Other: Usual (Conventional) Care; Other: Naturopathic Care

• Study Type: Interventional
• Enrollment (Anticipated): 148
• Phase: Phase 2; Phase 1

Contacts and Locations

• Study Contact: Name: Ellen Wong, ND; Phone Number: 303 416-498-1255; Email: ewong@ccnm.edu
• Study Contact Backup: Name: Kieran Cooley, ND; Phone Number: 324 416-498-1255; Email: kcooley@ccnm.edu

Study Locations

• Canada
  • Ontario
    • Brampton, Ontario, Canada, L6V 4H4
      • Wise Elephant Family Health Team
      • Contact: Sanjeev Goel, MD; Phone Number: (289) 323-0660
    • Toronto, Ontario, Canada, M2K 1E2
      • The Canadian College of Naturopathic Medicine

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 21 years to 75 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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:

  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

Study Plan

How is the study designed?

Design Details

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

Number of Arms

2

Arms and Interventions

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

What is the study measuring?

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
Adverse Events		2 year
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

Collaborators and Investigators

• Sponsor: The Canadian College of Naturopathic Medicine
• Investigators: Principal Investigator: Ellen Wong, ND, The Canadian College of Naturopathic Medicine

Study record dates

Study Major Dates

• Study Start: July 1, 2016
• Primary Completion (Anticipated): December 1, 2018
• Study Completion (Anticipated): July 1, 2019

Study Registration Dates

• First Submitted: July 14, 2016
• First Submitted That Met QC Criteria: July 21, 2016
• First Posted (Estimate): July 26, 2016

Study Record Updates

• Last Update Posted (Estimate): July 26, 2016
• Last Update Submitted That Met QC Criteria: July 21, 2016
• Last Verified: July 1, 2016

More Information

Terms related to this study

• Keywords: Uncontrolled Type 2 Diabetes; HbA1c >7.0%
• Additional Relevant MeSH Terms: Glucose Metabolism Disorders; Metabolic Diseases; Endocrine System Diseases; Diabetes Mellitus; Diabetes Mellitus, Type 2
• Other Study ID Numbers: CanadianCNN

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO