Integrative Care for Type 2 Diabetes

Phase 1

• Conditions: Diabetes Mellitus, Type 2
• Interventions: Other: Usual (Conventional) Care; Other: Naturopathic Care

• Registration Number: NCT02843724
• Lead Sponsor: The Canadian College of Naturopathic Medicine

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.

Detailed Description

Not available

Study Timeline

• Status Verified: 2016-07
• Study Start: 2016-07
• Study First Submitted: 2016-07-14
• Study First Submitted QC: 2016-07-21
• Last Update Submitted: 2016-07-21
• Study First Posted: 2016-07-26
• Last Update Posted: 2016-07-26
• Primary Completion: 2018-12
• Study Completion: 2019-07

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 148

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 & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Control (Conventional) Arm	Usual (Conventional) Care	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.
Integrative (Naturopathic + Conventional) Arm	Naturopathic Care	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.
Integrative (Naturopathic + Conventional) Arm	Usual (Conventional) Care	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.

Primary Outcome Measures

Name	Time	Method
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 Outcome Measures

Name	Time	Method
Weight (as part of BMI)	2 year	Kg
Incidence of metabolic syndrome	2 year
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
High-sensitivity C-reactive protein (hs-CRP)	2 year	Biomarker associated with cardiovascular risk
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

Trial Locations

Locations (2)

Wise Elephant Family Health Team; 🇨🇦 Brampton, Ontario, Canada

The Canadian College of Naturopathic Medicine; 🇨🇦 Toronto, Ontario, Canada