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临床试验/NCT03234946
NCT03234946Unknown不适用

Effect of the CAIPaDi Care Model in Relatives of Patients With Type 2 Diabetes Mellitus

Instituto Nacional de Ciencias Medicas y Nutricion Salvador Zubiran4 个研究点 分布在 1 个国家目标入组 97 人开始时间: 2017年6月19日最近更新:
适应症

试验速览

阶段
不适用
发起方
入组人数
97
试验地点
4
主要终点
Glycated hemoglobin

研究概览

简要总结

Diabetes is a chronic disease that requires long-term lifestyle changes that may affect the whole family. Hence, during the last decade, studies have focused mainly in the role of the members of the family and their influence in life quality or clinical outcomes of patients with diabetes. Therefore, the delivery of education only to the patients with type 2 diabetes mellitus may restrict the expectations of success in achieving the necessary modifications in lifestyle.

Objectives: To assess the effect of the CAIPaDi (Centre of Comprehensive Care for the Patients with Diabetes) program interventions on various health indicators relatives of patients with type 2 diabetes mellitus.

详细描述

Diabetes mellitus is one of the most challenging health issues of our time, the percentage of adults with this disease tripled in Mexico between 1993 and 2012; In 1993 the prevalence was 6.7% (cases previously diagnosed 4.6% and diagnosed during the survey 2.1%), whereas in 2012, the prevalence was 14.4% (7.3% previously diagnosed and 7.1% diagnosed during the survey) Identifying individuals at risk for developing diabetes and implementing prevention strategies is the optimal solution. Carbohydrate intolerance and impaired fasting glucose raise the risk of developing diabetes up to 20 times compared to those with normal levels of HbA1C and a progression rate to diabetes of 10% per year in the absence of any intervention.

Randomized studies have shown that progression from impaired fasting glucose and glucose intolerance to type 2 diabetes mellitus and its complications can be prevented by interventions focused on changes in lifestyle. This contributed to the implementation of new guidelines for the management of prediabetes, emphasizing the importance of timely interventions in this condition, which may be the most cost-effective alternative to avoid complications.

One of the most important studies in primary diabetes prevention, the Diabetes Prevention Program (DPP), provided scientific evidence on the prevention and delay in the onset of diabetes in high-risk individuals, with a 58% risk reduction through lifestyle modifications, such as reduced fat and calorie intake, increased physical activity up to at least 150 minutes per week and loss of 5-7% of body weight.

Another multicenter, randomized trial, the Finnish Diabetes Prevention Study (DPS), showed that type 2 diabetes is preventable with lifestyle multidisciplinary interventions, with a 58% risk reduction similar to that of the DPP study in the group who received intensive treatment, compared to the control group, even significant changes were observed in metabolic parameters one and three years afterwards.

In addition, a randomized, multicenter study in the city of Da Qing, China, with a population of 110,660 participants, demonstrated that diet and / or exercise lead to a significant decrease in the incidence of diabetes over a 6-year period in patients with carbohydrate intolerance, with an incidence of 67.7% in the control group, 43.8% in the group undergoing dietary changes and 46% in the diet and exercise group.

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
18 Years 至 65 Years(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • Being a relative of a patient of CAIPaDi
  • Fasting glucose of <125 mg/dl
  • Serum glucose of <199 mg/dl 2 hours after a glucose load of 75 gr

排除标准

  • Diagnosis of diabetes
  • Who has any disabling or priority health condition other than prevention of diabetes

结局指标

主要结局

Glycated hemoglobin

时间窗: 1 year

60% of patients with a glycated hemoglobin of \<5.8

Body Mass Index

时间窗: 1 year

Difference of 2kg/m2 between groups

次要结局

  • Triglycerides(1 year)
  • Serum glucose(1 year)
  • Non-HDL cholesterol(1 year)
  • Blood pressure(1 year)
  • Weight loss(1 year)
  • Minutes of exercise per day(1 year)
  • Steps per day(1 year)
  • Waist circumference(1 year)
  • Hospital Anxiety and Depression Scale (HAD)(1 year)

研究者

发起方
Instituto Nacional de Ciencias Medicas y Nutricion Salvador Zubiran
申办方类型
Other
责任方
Sponsor

研究点 (4)

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