Beating Diabetes Together: A Randomized Controlled Trial for Intensive Lifestyle Therapy for Youth With Type 2 Diabetes
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 15
- 试验地点
- 1
- 主要终点
- Glycemic control determined by a standard fasting measure of glycosylated hemoglobin using internationally recognized DCCT assay
研究概览
简要总结
Background: Little is known about the efficacy of intensive lifestyle therapy (i.e. increased physical activity and dietary changes) for the management of glycemia and cardiometabolic risk factors in children and adolescents with type 2 diabetes (T2DM).
Our hypothesis is that education regarding healthy lifestyle changes will significantly reduce blood sugars in youth with T2DM that do not require insulin therapy. Our secondary hypothesis is that the intensive lifestyle therapy will cause quick and sustained reductions in health risk measured by body mass index (BMI), blood pressure, waist circumference, LDL cholesterol, serum triglycerides and apolipoprotein B.
详细描述
Youth between the ages of 10-20 years living with type 2 diabetes and not currently on insulin therapy will be randomly assigned to either a lifestyle intervention group or a control group. The lifestyle intervention group will meet 2-3 times per week for 16 weeks to take part in healthy living education sessions involving physical activity, healthy cooking, healthy gardening and how to start and sustain a healthy lifestyle change. At the beginning and end of the 16 weeks the investigators will measure the participants' blood sugars, height, weight, cholesterol, triglycerides and liver enzymes. The investigators will also take a picture of their kidney, heart and blood vessels using ultrasound. Those youth assigned to the control group will receive the 16 week intervention following their 16 week control period.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Prevention
- 盲法
- None
入排标准
- 年龄范围
- 10 Years 至 20 Years（Child, Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •youth with a BMI considered overweight according to the International Obesity Task Force
- •diagnosed with type 2 diabetes, confirmed with a 2-hour oral glucose tolerance test within two years of enrollment
排除标准
- •youth with type 1 diabetes
- •use of insulin or other anti-diabetic drugs
- •youth with medication-induced diabetes
- •youth who have recently been admitted to hospital with ketoacidosis
- •youth have experienced weight loss or enrolled in a weightloss program in the last 6 months
- •youth with an orthapaedic injury preventing them from exercising
- •youth who have a history of alcohol or drug abuse
研究组 & 干预措施
Lifestyle counselling
Exercise, nutrition and self-efficacy based lifestyle training in a peer mentoring setting
干预措施: Lifestyle Counselling (Behavioral)
Control
Youth randomized to the control group will receive standard care for the first 16 weeks followed by 16 weeks of intervention
结局指标
主要结局
Glycemic control determined by a standard fasting measure of glycosylated hemoglobin using internationally recognized DCCT assay
时间窗: 16 weeks
次要结局
- Anthropometrics(16 weeks)
- Cardiovascular structure and function(16 weeks)
- Cardiometabolic risk Z score(16 weeks)
- Hypertension(16 weeks)
- Presence of microalbuminuria(16 weeks)
研究者
Jon McGavock
Assistant Professor
University of Manitoba