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Trial record 6 of 859 for:    Recruiting, Not yet recruiting, Available Studies | "Diabetes Mellitus, Type 2"

Integrative Care for Type 2 Diabetes

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ClinicalTrials.gov Identifier: NCT02843724
Recruitment Status : 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

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.

Condition or disease Intervention/treatment Phase
Diabetes Mellitus, Type 2 Other: Naturopathic Care Other: Usual (Conventional) Care Phase 1 Phase 2

Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 148 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Integrative Care for Type 2 Diabetes: Evaluating the Impact of Naturopathic Adjunctive Care for Diabetic Patients of a Family Health Team
Study Start Date : July 2016
Estimated Primary Completion Date : December 2018
Estimated Study Completion Date : July 2019

Resource links provided by the National Library of Medicine


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: 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




Primary Outcome Measures :
  1. 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


Secondary Outcome Measures :
  1. Incidence of metabolic syndrome [ Time Frame: 2 year ]
  2. Weight (as part of BMI) [ Time Frame: 2 year ]
    Kg

  3. Height (as part of BMI) [ Time Frame: 2 year ]
    meters

  4. Waist circumference (as part of metabolic syndrome) [ Time Frame: 2 year ]
    inches

  5. Fasting blood glucose [ Time Frame: 2 year ]
    Fasting glucose (FG), biomarker associated with diabetes

  6. Glycated hemoglobin (HbA1c) [ Time Frame: 2 year ]
    Biomarker associated with diabetes

  7. Blood pressure (BP) [ Time Frame: 2 year ]
    Systolic and diastolic blood pressure, seated, resting

  8. Total cholesterol (TC) (blood) [ Time Frame: 2 year ]
    Biomarkers associated with cholesterol & cardiovascular risk

  9. High-density lipoprotein (HDL-C) (blood) [ Time Frame: 2 year ]
    Biomarkers associated with cholesterol & cardiovascular risk

  10. Low-density lipoprotein (LDL-C) (blood) [ Time Frame: 2 year ]
    Biomarkers associated with cholesterol & cardiovascular risk

  11. Triglycerides (TG))(blood) [ Time Frame: 2 year ]
    Biomarkers associated with cholesterol & cardiovascular risk

  12. High-sensitivity C-reactive protein (hs-CRP) [ Time Frame: 2 year ]
    Biomarker associated with cardiovascular risk

  13. Incidence of smoking [ Time Frame: 2 year ]
    Modifiable risk factors for cardiovascular disease

  14. Incidence of obesity [ Time Frame: 2 year ]
    Modifiable risk factors for cardiovascular disease, BMI equal to or greater than 30.0 kg/m2

  15. Incidence of depression (PHQ-9) [ Time Frame: 2 year ]
    Depression as defined by the PHQ-9

  16. Impact on stress, anxiety, quality of life [ Time Frame: 2 year ]
    ADDQol

  17. Impact on anxiety [ Time Frame: 2 year ]
    GAD 7

  18. DES [ Time Frame: 2 year ]
    Impact on quality of life

  19. SF-12 [ Time Frame: 2 year ]
    Impact on quality of life

  20. Compliance/adherence with treatment prescriptions including changes in lifestyle, diet, exercise, and nutraceutical supplementation [ Time Frame: 2 year ]
    Diet and physical activity tracker

  21. Compliance/adherence with pharmaceutical prescriptions using a medication adherence questionnaire [ Time Frame: 2 year ]
    MMAQ

  22. Adverse Events [ Time Frame: 2 year ]


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Ages Eligible for Study:   21 Years to 75 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02843724


Contacts
Contact: Ellen Wong, ND 416-498-1255 ext 303 ewong@ccnm.edu
Contact: Kieran Cooley, ND 416-498-1255 ext 324 kcooley@ccnm.edu

Locations
Canada, Ontario
Wise Elephant Family Health Team Not yet recruiting
Brampton, Ontario, Canada, L6V 4H4
Contact: Sanjeev Goel, MD    (289) 323-0660      
The Canadian College of Naturopathic Medicine
Toronto, Ontario, Canada, M2K 1E2
Sponsors and Collaborators
The Canadian College of Naturopathic Medicine
Investigators
Principal Investigator: Ellen Wong, ND The Canadian College of Naturopathic Medicine

Responsible Party: Ellen Wong, Co Principal Investigator, The Canadian College of Naturopathic Medicine
ClinicalTrials.gov Identifier: NCT02843724     History of Changes
Other Study ID Numbers: CanadianCNN
First Posted: July 26, 2016    Key Record Dates
Last Update Posted: July 26, 2016
Last Verified: July 2016
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

Keywords provided by Ellen Wong, The Canadian College of Naturopathic Medicine:
Uncontrolled Type 2 Diabetes
HbA1c >7.0%

Additional relevant MeSH terms:
Diabetes Mellitus
Diabetes Mellitus, Type 2
Glucose Metabolism Disorders
Metabolic Diseases
Endocrine System Diseases