Diet and Physical Activity Lifestyle Intervention to Prevent Body Weight Gain in Patients With Type 2 Diabetes Starting Insulin Pump Treatment: a Randomized Controlled Trial
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- Icadom
- 入组人数
- 54
- 试验地点
- 12
- 主要终点
- Weight change
研究概览
简要总结
The purpose of the study is to determine whether a personalized lifestyle intervention focused on diet and physical activity reinforcement is effective in avoiding weight gain in the first months following initiation of subcutaneous insulin pump therapy in type-2 diabetic patients.
详细描述
Patients with type 2 diabetes using insulin pump therapy are gaining weight within the first months of treatment. This weight gain could counterbalance the metabolic benefice of insulin pump treatment in improving glycemic control and could lead to treatment dropout. Lifestyle intervention aiming at improving physical activity and diet in type 2 diabetes is known to brought body weight reduction and cardiometabolic improvement.
The investigator hypothesized that an intensive, home-based, 6-months diet and physical activity program could prevent the body weight gain associated with insulin pump treatment initiation. The investigator will randomize patients with type 2 diabetes into a "lifestyle intervention" arm or a "usual care" control arm at the time of insulin pump treatment initiation. The primary objective will evaluate body weight change at 6 months after insulin pump treatment initiation. The secondary objectives will evaluate change in glycemic control (HbA1c) and body composition at 6 months. In addition, the retention effect will be assessed on body weight change one year after insulin pump treatment initiation, 6 months after the end of the lifestyle intervention.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Supportive Care
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Adult Type 2 diabetic patients with indication of initiation of insulin pump therapy.
- •Patients addressed for the insulin pump follow-up to the home care provider supporting the study.
- •Public health care security affiliation.
排除标准
- •Breastfeeding or pregnant woman.
- •Not willing to participate as assessed by the investigator.
- •Patient engaged in another clinical trial with exclusion criteria for other protocol.
- •Patients unable to ride a training bike.
- •Unavailable in the next 6 months.
- •Patient without a medical certificate done in the last 12 months by a cardiologist attesting the ability to participate in a physical activity reinforcement program.
结局指标
主要结局
Weight change
时间窗: 6 months
The difference in body weight changes between the two groups over a six-month period following initiation of insulin pump treatment.
次要结局
- Body composition(6 months)
- Retention of weight change(1 year)
- Glycemic control(6 months)
- Diabetes Treatment Satisfaction(6 months)
- Intermediate weight change(3 months)