Clinical and Economic Benefits of Cardiovascular Risk Management by a Dietician in Diabetic Patients
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 101
- 试验地点
- 2
- 主要终点
- Lipid profile
研究概览
简要总结
Worldwide, health systems and practitioners are facing obesity epidemics. High blood pressure, dyslipidemia and diabetes prevalence will explode during the 21st century.
The two main objectives of this 2-year controlled prospective study are:
- to demonstrate that, for patients with high blood pressure, diabetes and dyslipidemia, dietician conducted survey and management in combination with annual endocrinologist follow-up enable both attainment and maintenance of recommended blood pressure, glycemic and lipid goals, as well as smoking cessation;
- to demonstrate that dietician management is more cost effective than conventional care provided by general practitioners and endocrinologists.
Results are expected to show significantly different cardiovascular risk profiles (BMI and waist circumference, systolic and diastolic blood pressure, LDL-C, triglycerides and Total cholesterol/HDL ratio, HbA1c, smoking) between baseline and after 2 years follow-up. Sample size was determined in order to show statistically significant differences between the two groups.
Results will document for the benefit of care givers, health economists and policy makers alike an innovative and integrated model of care which is expected to be effective at the patient level as well as cost effective with respect to the increasing financial burden of diabetes on the health system.
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
- 18 Years 至 —(Adult, Older Adult)
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •HbA1c > 7%
- •More than 2 follow-up visits
排除标准
- 未提供
研究组 & 干预措施
Intensive treatment
Submitted to an intensive follow-up by the dietician.
干预措施: Intensive treatment (Behavioral)
Usual treatment
Subjects will remain under the care of their endocrinologist and/or general practitioner.
干预措施: Normal follow-up (Other)
结局指标
主要结局
Lipid profile
时间窗: 36 months
Blood pressure
时间窗: 36 months
HbA1c
时间窗: 36 months
次要结局
未报告次要终点
研究者
Jean-Luc Ardilouze
Endocrinologist, researcher
Université de Sherbrooke
