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临床试验/NCT00444899
NCT00444899已完成不适用

Clinical and Economic Benefits of Cardiovascular Risk Management by a Dietician in Diabetic Patients

Université de Sherbrooke2 个研究点 分布在 1 个国家目标入组 101 人开始时间: 2007年3月最近更新:
适应症
干预措施

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:

  1. 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;
  2. 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

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

Experimental

Submitted to an intensive follow-up by the dietician.

干预措施: Intensive treatment (Behavioral)

Usual treatment

Active Comparator

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

申办方类型
Other
责任方
Principal Investigator
主要研究者

Jean-Luc Ardilouze

Endocrinologist, researcher

Université de Sherbrooke

研究点 (2)

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