DEMOJUAN- DEMOnstration Area for Primary Prevention of Type 2 Diabetes, JUAN Mina and Barranquilla, Colombia
Condition: Type 2 Diabetes; Glucose Metabolism Disorders
MeSH terms: Diabetes Mellitus; Diabetes Mellitus, Type 2; Metabolic Diseases; Glucose Metabolism Disorders
Study type: Interventional

Summary: 
      The main aim of this study is to investigate to what extent it is possible to reach normal
      glucose metabolism and optimal cardiovascular disease (CVD) risk factor levels with early
      lifestyle interventions in people at high risk of type 2 diabetes compared with those who
      receive standard therapy (usual care) only.

      The project will show the effect of these interventions for the first time in people of low
      socio-economic levels living in a Caribbean environment.
    

Detailed description: 
      Type 2 diabetes (T2D) is one of the fastest growing public health problems in both developed
      and developing countries. The development of T2D is a slow process and involves both genetic
      and environmental effects. It is commonly agreed that T2D may develop only in people that
      carry a genetic predisposition to the disease. Based on epidemiological observations about
      half of the people will develop T2D during their lifetime, and up to 30-35% will have IGT.
      Therefore, it is likely that more than half of the population carry genes that predispose the
      development of T2D. In people genetically predisposed to the disease, the probability to
      develop T2D is very high once exposed to unhealthy lifestyles such as obesity, unbalanced
      diet and physical inactivity. While we cannot change the genes, the only way to prevent T2D
      and its serious complications is the modification of lifestyle risk factors. Therefore, it is
      very important to understand the role of preventive lifestyle intervention as a key treatment
      in T2D prevention. Once established, T2D is difficult to treat. Despite pharmacologic
      treatment blood glucose levels trend to increase over time. Thus, the most efficient way to
      manage T2D is to prevent diabetes from developing. Also complications of T2D can best be
      postponed by postponing the onset of the primary disease itself. The efforts to prevent the
      disease need to start as early as possible and address all susceptibility factors.
      Fortunately, recent studies have convincingly demonstrated that prevention of T2D is
      possible. This project will show for the first time how lifestyle interventions work in
      people with IGT in the Caribbean population. The results of this study will be sued for
      policy making and planning of primary prevention activities not only in the local health-care
      system but in the entire Caribbean region.
    

Intervention name(s): Lifestyle intervention (nutrition); Lifestyle intervention (physical activity)
Intervention type(s): Behavioral; Behavioral
Intervention description(s): The 200 study participants of this arm will first receive 6 months of Nutritional counseling and thereafter combined nutrition/physical activity counseling during 18 month. The counseling sessions consists of monthly group seminars (10 participants/group) and totally 6 individual visits with a nutritionist and 6 visits with a physical activity expert.; The 200 study participants of this arm will first receive 6 months of physical activity counseling and thereafter combined nutrition/physical activity counseling during 18 month. The counseling sessions consists of monthly group seminars (10 participants/group) and totally 6 individual visits with a nutritionist and 6 visits with a physical activity expert.
Allocation: Randomized
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Prevention
Keywords: impaired glucose tolerance; nutrition; physical activity