DEMOJUAN- DEMOnstration Area for Primary Prevention of Type 2 Diabetes, JUAN Mina and Barranquilla, Colombia

Centro de Investigacion Sanitaria

Status: Completed

Conditions: Glucose Metabolism Disorders; Type 2 Diabetes

Treatments: Behavioral: Lifestyle intervention (physical activity); Behavioral: Lifestyle intervention (nutrition)

Study type: Interventional

Funder types: Other; NETWORK

Identifiers

NCT01296100

LT09-258

Details and patient eligibility

About

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.

Full 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.

Enrollment: 730 patients

Sex: All

Ages: 34 to 69 years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• 34-69 years-of-age with diagnosed IGT
• Informed consent given.

Exclusion criteria

• Patients with pharmacologically-treated diabetes
• Hypertriglyceridaemia under drug treatment
• History of life-limiting diseases or events
• Unwillingness to sign the informed consent.

Trial design

Primary purpose: Prevention

Allocation: Randomized

Interventional model: Single Group Assignment

Masking: None (Open label)

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730 participants in 2 patient groups

Lifestyle intervention (nutrition)

Experimental group

Description:

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.

Treatment:

Behavioral: Lifestyle intervention (nutrition)

Lifestyle counseling (physical activity)

Experimental group

Description:

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.

Treatment:

Behavioral: Lifestyle intervention (physical activity)