Clinical trial NCT02843724: 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
Overall status: UNKNOWN
Phase: PHASE1
PHASE2
Conditions: Diabetes Mellitus, Type 2
Keywords: Uncontrolled Type 2 Diabetes
HbA1c >7.0%
Lead sponsor: The Canadian College of Naturopathic Medicine
Sponsor class: OTHER
First posted: 2016-07-26
Enrollment: 148
Sex: ALL
Minimum age (years): 21
Maximum age (years): 75
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.


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:

  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

Primary outcomes:
measure: Clinically meaningful reduction of HbA1c above and beyond that of control arm
timeFrame: 1 year
Secondary outcomes:
measure: Incidence of metabolic syndrome
timeFrame: 2 year
measure: Weight (as part of BMI)
timeFrame: 2 year
measure: Height (as part of BMI)
timeFrame: 2 year
measure: Waist circumference (as part of metabolic syndrome)
timeFrame: 2 year
measure: Fasting blood glucose
timeFrame: 2 year
measure: Glycated hemoglobin (HbA1c)
timeFrame: 2 year
measure: Blood pressure (BP)
timeFrame: 2 year
measure: Total cholesterol (TC) (blood)
timeFrame: 2 year
measure: High-density lipoprotein (HDL-C) (blood)
timeFrame: 2 year
measure: Low-density lipoprotein (LDL-C) (blood)
timeFrame: 2 year
measure: Triglycerides (TG))(blood)
timeFrame: 2 year
measure: High-sensitivity C-reactive protein (hs-CRP)
timeFrame: 2 year
measure: Incidence of smoking
timeFrame: 2 year
measure: Incidence of obesity
timeFrame: 2 year
measure: Incidence of depression (PHQ-9)
timeFrame: 2 year
measure: Impact on stress, anxiety, quality of life
timeFrame: 2 year
measure: Impact on anxiety
timeFrame: 2 year
measure: DES
timeFrame: 2 year
measure: SF-12
timeFrame: 2 year
measure: Compliance/adherence with treatment prescriptions including changes in lifestyle, diet, exercise, and nutraceutical supplementation
timeFrame: 2 year
measure: Compliance/adherence with pharmaceutical prescriptions using a medication adherence questionnaire
timeFrame: 2 year
measure: Adverse Events
timeFrame: 2 year
Other outcomes:
Locations:
city: Brampton
country: Canada
facility: Wise Elephant Family Health Team
state: Ontario
city: Toronto
country: Canada
facility: The Canadian College of Naturopathic Medicine
state: Ontario
Study officials:
affiliation: The Canadian College of Naturopathic Medicine
name: Ellen Wong, ND
role: PRINCIPAL_INVESTIGATOR
References: