Diabetes Mellitus, Type 2Phase 1/2NCT02843724
Integrative Care for Type 2 Diabetes
A Phase 1/2 study testing Naturopathic Care and Usual (Conventional) Care in people with Diabetes Mellitus, Type 2, run by The Canadian College of Naturopathic Medicine at 2 sites in Canada.
Trial 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. Read more about this study
- Who is it for?
- Ages 21 to 75 years
- Conditions the study is for
- Diabetes Mellitus, Type 2
- What is being tested?
- Naturopathic Care and Usual (Conventional) Care
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 148 participants
- Where
- 2 sitesCanada
- Study dates
- Jul 2016to Jul 2019
- Phase
- Phase 1/2
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 21 to 75 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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
Show all 15Show fewer
- 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
Trial locations and contacts
2 sites in 1 country.
Canada2 sites
Wise Elephant Family Health Team
Brampton, Ontario, L6V 4H4
Sanjeev Goel, MD, (289) 323-0660
The Canadian College of Naturopathic Medicine
Toronto, Ontario, M2K 1E2
About this study
Official title: Integrative Care for Type 2 Diabetes: Evaluating the Impact of Naturopathic Adjunctive Care for Diabetic Patients of a Family Health Team
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.
- Conditions
- Diabetes Mellitus, Type 2
- Being tested
- Naturopathic Care, Usual (Conventional) Care
- Keywords
- Uncontrolled Type 2 Diabetes, HbA1c >7.0%
- Medical subject headings
- Diabetes Mellitus, Type 2
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Naturopathic CareOther
Naturopathic diabetes care will be selected from a pre-approved menu. Participants' other health concerns will be addressed at naturopathic doctors' discretion
Usual (Conventional) CareOther
2016 Canadian Diabetes Clinical Practice Guidelines (self-management, blood-glucose-lowering, vascular protection, pharmacotherapy) will be implemented
| Study group | Role | What they receive |
|---|---|---|
| Control (Conventional) Arm | Active comparator | 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. Receives: Other: Usual (Conventional) Care |
| Integrative (Naturopathic + Conventional) Arm | Active comparator | 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. Receives: Other: Naturopathic Care; Other: Usual (Conventional) Care |
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Measured: 1 year
Secondary outcomes (22)
Incidence of metabolic syndrome
Measured: 2 year
Weight (as part of BMI)
Kg
Measured: 2 year
Height (as part of BMI)
meters
Measured: 2 year
Waist circumference (as part of metabolic syndrome)
inches
Measured: 2 year
Fasting blood glucose
Fasting glucose (FG), biomarker associated with diabetes
Measured: 2 year
Glycated hemoglobin (HbA1c)
Biomarker associated with diabetes
Measured: 2 year
Blood pressure (BP)
Systolic and diastolic blood pressure, seated, resting
Measured: 2 year
Total cholesterol (TC) (blood)
Biomarkers associated with cholesterol \& cardiovascular risk
Measured: 2 year
High-density lipoprotein (HDL-C) (blood)
Biomarkers associated with cholesterol \& cardiovascular risk
Measured: 2 year
Low-density lipoprotein (LDL-C) (blood)
Biomarkers associated with cholesterol \& cardiovascular risk
Measured: 2 year
Triglycerides (TG))(blood)
Biomarkers associated with cholesterol \& cardiovascular risk
Measured: 2 year
High-sensitivity C-reactive protein (hs-CRP)
Biomarker associated with cardiovascular risk
Measured: 2 year
Incidence of smoking
Modifiable risk factors for cardiovascular disease
Measured: 2 year
Incidence of obesity
Modifiable risk factors for cardiovascular disease, BMI equal to or greater than 30.0 kg/m2
Measured: 2 year
Incidence of depression (PHQ-9)
Depression as defined by the PHQ-9
Measured: 2 year
Impact on stress, anxiety, quality of life
ADDQol
Measured: 2 year
Impact on anxiety
GAD 7
Measured: 2 year
DES
Impact on quality of life
Measured: 2 year
SF-12
Impact on quality of life
Measured: 2 year
Compliance/adherence with treatment prescriptions including changes in lifestyle, diet, exercise, and nutraceutical supplementation
Diet and physical activity tracker
Measured: 2 year
Compliance/adherence with pharmaceutical prescriptions using a medication adherence questionnaire
MMAQ
Measured: 2 year
Adverse Events
Measured: 2 year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted26 Jul 2016 (estimated)
- Study startJul 2016
- Primary completionDec 2018 (estimated)
- Study completionJul 2019 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Diabetes Mellitus, Type 2Studies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 1/2
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 148 participants (estimated)
Sponsor and investigators
- Lead sponsor
- The Canadian College of Naturopathic Medicine
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Ellen Wong, The Canadian College of Naturopathic Medicine
- Investigators
- Ellen Wong, ND, Principal investigator, The Canadian College of Naturopathic Medicine
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02843724
- Sponsor's protocol ID
- CanadianCNN
- Status last verified
- Jul 2016
- First submitted
- 14 Jul 2016
- Last updated
- 26 Jul 2016
- Results posted
- No
- Data monitoring committee
- Yes
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 26 Jul 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Integrative Care for Type 2 Diabetes: Evaluating the Impact of Naturopathic Adjunctive Care for Diabetic Patients of a Family Health Team
- ClinicalTrials.gov ID
- NCT02843724
- Acronym / sponsor ID
- CanadianCNN
- Conditions
- Diabetes Mellitus, Type 2
- Keywords
- Uncontrolled Type 2 Diabetes, HbA1c >7.0%
- Phase
- Phase 1/2
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 148 participants (estimated)
- Lead sponsor
- The Canadian College of Naturopathic MedicineUniversity, hospital or other
- Study start
- Jul 2016
- Primary completion
- Dec 2018 (estimated)
- Study completion
- Jul 2019 (estimated)
- First posted
- 26 Jul 2016 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Control (Conventional) Arm | Active comparator | Other: Usual (Conventional) CareTreatment 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 | Active comparator | Other: Naturopathic Care, Other: Usual (Conventional) CareIn 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. |
Who may qualify
- Ages
- 21 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (8 listed)
- 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
Key exclusion criteria (15 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Naturopathic CareNaturopathic diabetes care will be selected from a pre-approved menu. Participants' other health concerns will be addressed at naturopathic doctors' discretion | Other | Integrative (Naturopathic + Conventional) Arm |
| Usual (Conventional) Care2016 Canadian Diabetes Clinical Practice Guidelines (self-management, blood-glucose-lowering, vascular protection, pharmacotherapy) will be implemented | Other | Control (Conventional) Arm, Integrative (Naturopathic + Conventional) Arm |
Primary outcome
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
22 secondary outcomes
Incidence of metabolic syndrome
Time frame: 2 year
Weight (as part of BMI)
Time frame: 2 year
Height (as part of BMI)
Time frame: 2 year
Waist circumference (as part of metabolic syndrome)
Time frame: 2 year
Fasting blood glucose
Time frame: 2 year
Glycated hemoglobin (HbA1c)
Time frame: 2 year
Blood pressure (BP)
Time frame: 2 year
Total cholesterol (TC) (blood)
Time frame: 2 year
High-density lipoprotein (HDL-C) (blood)
Time frame: 2 year
Low-density lipoprotein (LDL-C) (blood)
Time frame: 2 year
Triglycerides (TG))(blood)
Time frame: 2 year
High-sensitivity C-reactive protein (hs-CRP)
Time frame: 2 year
Incidence of smoking
Time frame: 2 year
Incidence of obesity
Time frame: 2 year
Incidence of depression (PHQ-9)
Time frame: 2 year
Impact on stress, anxiety, quality of life
Time frame: 2 year
Impact on anxiety
Time frame: 2 year
DES
Time frame: 2 year
SF-12
Time frame: 2 year
Compliance/adherence with treatment prescriptions including changes in lifestyle, diet, exercise, and nutraceutical supplementation
Time frame: 2 year
Compliance/adherence with pharmaceutical prescriptions using a medication adherence questionnaire
Time frame: 2 year
Adverse Events
Time frame: 2 year
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 26 Jul 2016.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Ellen Wong, ND principal investigator
The Canadian College of Naturopathic Medicine
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1/2 study testing Naturopathic Care and Usual (Conventional) Care in people with Diabetes Mellitus, Type 2, run by The Canadian College of Naturopathic Medicine at 2 sites in Canada.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 8 inclusion and 15 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 26 Jul 2016. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in Canada. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this combined phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Ellen Wong, ND (416-498-1255 ext. 303, ewong@ccnm.edu), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Clinically meaningful reduction of HbA1c above and beyond that of control arm (time frame: 1 year). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 26 Jul 2016.