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Integrative Care for Type 2 Diabetes

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT02843724
Recruitment Status : Unknown
Verified July 2016 by Ellen Wong, The Canadian College of Naturopathic Medicine.
Recruitment status was:  Not yet recruiting
First Posted : July 26, 2016
Last Update Posted : July 26, 2016
Sponsor:
Information provided by (Responsible Party):
Ellen Wong, The Canadian College of Naturopathic Medicine

Tracking Information
First Submitted Date  ICMJE July 14, 2016
First Posted Date  ICMJE July 26, 2016
Last Update Posted Date July 26, 2016
Study Start Date  ICMJE July 2016
Estimated Primary Completion Date December 2018   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: July 21, 2016)
Clinically meaningful reduction of HbA1c above and beyond that of control arm [ Time Frame: 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
Original Primary Outcome Measures  ICMJE Same as current
Change History No Changes Posted
Current Secondary Outcome Measures  ICMJE
 (submitted: July 21, 2016)
  • Incidence of metabolic syndrome [ Time Frame: 2 year ]
  • Weight (as part of BMI) [ Time Frame: 2 year ]
    Kg
  • Height (as part of BMI) [ Time Frame: 2 year ]
    meters
  • Waist circumference (as part of metabolic syndrome) [ Time Frame: 2 year ]
    inches
  • Fasting blood glucose [ Time Frame: 2 year ]
    Fasting glucose (FG), biomarker associated with diabetes
  • Glycated hemoglobin (HbA1c) [ Time Frame: 2 year ]
    Biomarker associated with diabetes
  • Blood pressure (BP) [ Time Frame: 2 year ]
    Systolic and diastolic blood pressure, seated, resting
  • Total cholesterol (TC) (blood) [ Time Frame: 2 year ]
    Biomarkers associated with cholesterol & cardiovascular risk
  • High-density lipoprotein (HDL-C) (blood) [ Time Frame: 2 year ]
    Biomarkers associated with cholesterol & cardiovascular risk
  • Low-density lipoprotein (LDL-C) (blood) [ Time Frame: 2 year ]
    Biomarkers associated with cholesterol & cardiovascular risk
  • Triglycerides (TG))(blood) [ Time Frame: 2 year ]
    Biomarkers associated with cholesterol & cardiovascular risk
  • High-sensitivity C-reactive protein (hs-CRP) [ Time Frame: 2 year ]
    Biomarker associated with cardiovascular risk
  • Incidence of smoking [ Time Frame: 2 year ]
    Modifiable risk factors for cardiovascular disease
  • Incidence of obesity [ Time Frame: 2 year ]
    Modifiable risk factors for cardiovascular disease, BMI equal to or greater than 30.0 kg/m2
  • Incidence of depression (PHQ-9) [ Time Frame: 2 year ]
    Depression as defined by the PHQ-9
  • Impact on stress, anxiety, quality of life [ Time Frame: 2 year ]
    ADDQol
  • Impact on anxiety [ Time Frame: 2 year ]
    GAD 7
  • DES [ Time Frame: 2 year ]
    Impact on quality of life
  • SF-12 [ Time Frame: 2 year ]
    Impact on quality of life
  • Compliance/adherence with treatment prescriptions including changes in lifestyle, diet, exercise, and nutraceutical supplementation [ Time Frame: 2 year ]
    Diet and physical activity tracker
  • Compliance/adherence with pharmaceutical prescriptions using a medication adherence questionnaire [ Time Frame: 2 year ]
    MMAQ
  • Adverse Events [ Time Frame: 2 year ]
Original Secondary Outcome Measures  ICMJE Same as current
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Integrative Care for Type 2 Diabetes
Official Title  ICMJE Integrative Care for Type 2 Diabetes: Evaluating the Impact of Naturopathic Adjunctive Care for Diabetic Patients of a Family Health Team
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 Provided
Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 1
Phase 2
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Condition  ICMJE Diabetes Mellitus, Type 2
Intervention  ICMJE
  • 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
  • Other: Usual (Conventional) Care
    2016 Canadian Diabetes Clinical Practice Guidelines (self-management, blood-glucose-lowering, vascular protection, pharmacotherapy) will be implemented
Study Arms  ICMJE
  • 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.
    Intervention: Other: Usual (Conventional) Care
  • 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.
    Interventions:
    • Other: Naturopathic Care
    • Other: Usual (Conventional) Care
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Unknown status
Estimated Enrollment  ICMJE
 (submitted: July 21, 2016)
148
Original Estimated Enrollment  ICMJE Same as current
Estimated Study Completion Date  ICMJE July 2019
Estimated Primary Completion Date December 2018   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 21 Years to 75 Years   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE Canada
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT02843724
Other Study ID Numbers  ICMJE CanadianCNN
Has Data Monitoring Committee Yes
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE
Plan to Share IPD: No
Responsible Party Ellen Wong, The Canadian College of Naturopathic Medicine
Study Sponsor  ICMJE The Canadian College of Naturopathic Medicine
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Principal Investigator: Ellen Wong, ND The Canadian College of Naturopathic Medicine
PRS Account The Canadian College of Naturopathic Medicine
Verification Date July 2016

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP