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Integrative Care for Type 2 Diabetes

Primary Purpose

Diabetes Mellitus, Type 2

Status
Unknown status
Phase
Phase 1
Locations
Canada
Study Type
Interventional
Intervention
Naturopathic Care
Usual (Conventional) Care
Sponsored by
The Canadian College of Naturopathic Medicine
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Diabetes Mellitus, Type 2 focused on measuring Uncontrolled Type 2 Diabetes, HbA1c >7.0%

Eligibility Criteria

21 Years - 75 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • Wise Elephant Family Health Team
  • The Canadian College of Naturopathic Medicine

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

Active Comparator

Arm Label

Control (Conventional) Arm

Integrative (Naturopathic + Conventional) Arm

Arm Description

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.

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.

Outcomes

Primary Outcome Measures

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

Secondary Outcome Measures

Incidence of metabolic syndrome
Weight (as part of BMI)
Kg
Height (as part of BMI)
meters
Waist circumference (as part of metabolic syndrome)
inches
Fasting blood glucose
Fasting glucose (FG), biomarker associated with diabetes
Glycated hemoglobin (HbA1c)
Biomarker associated with diabetes
Blood pressure (BP)
Systolic and diastolic blood pressure, seated, resting
Total cholesterol (TC) (blood)
Biomarkers associated with cholesterol & cardiovascular risk
High-density lipoprotein (HDL-C) (blood)
Biomarkers associated with cholesterol & cardiovascular risk
Low-density lipoprotein (LDL-C) (blood)
Biomarkers associated with cholesterol & cardiovascular risk
Triglycerides (TG))(blood)
Biomarkers associated with cholesterol & cardiovascular risk
High-sensitivity C-reactive protein (hs-CRP)
Biomarker associated with cardiovascular risk
Incidence of smoking
Modifiable risk factors for cardiovascular disease
Incidence of obesity
Modifiable risk factors for cardiovascular disease, BMI equal to or greater than 30.0 kg/m2
Incidence of depression (PHQ-9)
Depression as defined by the PHQ-9
Impact on stress, anxiety, quality of life
ADDQol
Impact on anxiety
GAD 7
DES
Impact on quality of life
SF-12
Impact on quality of life
Compliance/adherence with treatment prescriptions including changes in lifestyle, diet, exercise, and nutraceutical supplementation
Diet and physical activity tracker
Compliance/adherence with pharmaceutical prescriptions using a medication adherence questionnaire
MMAQ
Adverse Events

Full Information

First Posted
July 14, 2016
Last Updated
July 21, 2016
Sponsor
The Canadian College of Naturopathic Medicine
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1. Study Identification

Unique Protocol Identification Number
NCT02843724
Brief Title
Integrative Care for Type 2 Diabetes
Official Title
Integrative Care for Type 2 Diabetes: Evaluating the Impact of Naturopathic Adjunctive Care for Diabetic Patients of a Family Health Team
Study Type
Interventional

2. Study Status

Record Verification Date
July 2016
Overall Recruitment Status
Unknown status
Study Start Date
July 2016 (undefined)
Primary Completion Date
December 2018 (Anticipated)
Study Completion Date
July 2019 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
The Canadian College of Naturopathic Medicine

4. Oversight

Data Monitoring Committee
Yes

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Diabetes Mellitus, Type 2
Keywords
Uncontrolled Type 2 Diabetes, HbA1c >7.0%

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 1, Phase 2
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
148 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Control (Conventional) Arm
Arm Type
Active Comparator
Arm Description
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.
Arm Title
Integrative (Naturopathic + Conventional) Arm
Arm Type
Active Comparator
Arm Description
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.
Intervention Type
Other
Intervention Name(s)
Naturopathic Care
Intervention Description
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
Intervention Name(s)
Usual (Conventional) Care
Intervention Description
2016 Canadian Diabetes Clinical Practice Guidelines (self-management, blood-glucose-lowering, vascular protection, pharmacotherapy) will be implemented
Primary Outcome Measure Information:
Title
Clinically meaningful reduction of HbA1c above and beyond that of control arm
Description
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
Secondary Outcome Measure Information:
Title
Incidence of metabolic syndrome
Time Frame
2 year
Title
Weight (as part of BMI)
Description
Kg
Time Frame
2 year
Title
Height (as part of BMI)
Description
meters
Time Frame
2 year
Title
Waist circumference (as part of metabolic syndrome)
Description
inches
Time Frame
2 year
Title
Fasting blood glucose
Description
Fasting glucose (FG), biomarker associated with diabetes
Time Frame
2 year
Title
Glycated hemoglobin (HbA1c)
Description
Biomarker associated with diabetes
Time Frame
2 year
Title
Blood pressure (BP)
Description
Systolic and diastolic blood pressure, seated, resting
Time Frame
2 year
Title
Total cholesterol (TC) (blood)
Description
Biomarkers associated with cholesterol & cardiovascular risk
Time Frame
2 year
Title
High-density lipoprotein (HDL-C) (blood)
Description
Biomarkers associated with cholesterol & cardiovascular risk
Time Frame
2 year
Title
Low-density lipoprotein (LDL-C) (blood)
Description
Biomarkers associated with cholesterol & cardiovascular risk
Time Frame
2 year
Title
Triglycerides (TG))(blood)
Description
Biomarkers associated with cholesterol & cardiovascular risk
Time Frame
2 year
Title
High-sensitivity C-reactive protein (hs-CRP)
Description
Biomarker associated with cardiovascular risk
Time Frame
2 year
Title
Incidence of smoking
Description
Modifiable risk factors for cardiovascular disease
Time Frame
2 year
Title
Incidence of obesity
Description
Modifiable risk factors for cardiovascular disease, BMI equal to or greater than 30.0 kg/m2
Time Frame
2 year
Title
Incidence of depression (PHQ-9)
Description
Depression as defined by the PHQ-9
Time Frame
2 year
Title
Impact on stress, anxiety, quality of life
Description
ADDQol
Time Frame
2 year
Title
Impact on anxiety
Description
GAD 7
Time Frame
2 year
Title
DES
Description
Impact on quality of life
Time Frame
2 year
Title
SF-12
Description
Impact on quality of life
Time Frame
2 year
Title
Compliance/adherence with treatment prescriptions including changes in lifestyle, diet, exercise, and nutraceutical supplementation
Description
Diet and physical activity tracker
Time Frame
2 year
Title
Compliance/adherence with pharmaceutical prescriptions using a medication adherence questionnaire
Description
MMAQ
Time Frame
2 year
Title
Adverse Events
Time Frame
2 year

10. Eligibility

Sex
All
Minimum Age & Unit of Time
21 Years
Maximum Age & Unit of Time
75 Years
Accepts Healthy Volunteers
No
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) In participants aged 65yoa to 75yoa, the following also serve as exclusion criteria: 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
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Ellen Wong, ND
Phone
416-498-1255
Ext
303
Email
ewong@ccnm.edu
First Name & Middle Initial & Last Name or Official Title & Degree
Kieran Cooley, ND
Phone
416-498-1255
Ext
324
Email
kcooley@ccnm.edu
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Ellen Wong, ND
Organizational Affiliation
The Canadian College of Naturopathic Medicine
Official's Role
Principal Investigator
Facility Information:
Facility Name
Wise Elephant Family Health Team
City
Brampton
State/Province
Ontario
ZIP/Postal Code
L6V 4H4
Country
Canada
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Sanjeev Goel, MD
Phone
(289) 323-0660
Facility Name
The Canadian College of Naturopathic Medicine
City
Toronto
State/Province
Ontario
ZIP/Postal Code
M2K 1E2
Country
Canada

12. IPD Sharing Statement

Plan to Share IPD
No

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Integrative Care for Type 2 Diabetes

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