NCT02843724Unknown1 期
Integrative Care for Type 2 Diabetes: Evaluating the Impact of Naturopathic Adjunctive Care for Diabetic Patients of a Family Health Team
适应症
试验速览
- 阶段
- 1 期
- 入组人数
- 148
- 试验地点
- 4
- 主要终点
- Clinically meaningful reduction of HbA1c above and beyond that of control arm
研究概览
简要总结
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.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 21 Years 至 75 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •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
排除标准
- •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:
- •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
结局指标
主要结局
Clinically meaningful reduction of HbA1c above and beyond that of control arm
时间窗: 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
次要结局
- Incidence of smoking(2 year)
- Impact on stress, anxiety, quality of life(2 year)
- High-sensitivity C-reactive protein (hs-CRP)(2 year)
- Incidence of metabolic syndrome(2 year)
- Weight (as part of BMI)(2 year)
- Height (as part of BMI)(2 year)
- Waist circumference (as part of metabolic syndrome)(2 year)
- Fasting blood glucose(2 year)
- Glycated hemoglobin (HbA1c)(2 year)
- Blood pressure (BP)(2 year)
- Total cholesterol (TC) (blood)(2 year)
- High-density lipoprotein (HDL-C) (blood)(2 year)
- Low-density lipoprotein (LDL-C) (blood)(2 year)
- Triglycerides (TG))(blood)(2 year)
- Incidence of obesity(2 year)
- Incidence of depression (PHQ-9)(2 year)
- Impact on anxiety(2 year)
- DES(2 year)
- SF-12(2 year)
- Compliance/adherence with treatment prescriptions including changes in lifestyle, diet, exercise, and nutraceutical supplementation(2 year)
- Compliance/adherence with pharmaceutical prescriptions using a medication adherence questionnaire(2 year)
- Adverse Events(2 year)
研究者
Ellen Wong
Co Principal Investigator
The Canadian College of Naturopathic Medicine
研究点 (4)
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