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

Study Overview
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Brief Summary
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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
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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.

Official Title
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DEMOnstration Area for Primary Prevention of Type 2 Diabetes, JUAN Mina and Barranquilla, Colombia

Conditions
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Type 2 Diabetes, Glucose Metabolism Disorders

Intervention / Treatment
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* Behavioral: Lifestyle intervention (nutrition)
* Behavioral: Lifestyle intervention (physical activity)


Participation Criteria
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Eligibility Criteria
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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.

Ages Eligible for Study
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Minimum Age: 34 Years
Maximum Age: 69 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Prevention
Allocation: Randomized
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Lifestyle intervention (nutrition)<br>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. | Behavioral: Lifestyle intervention (nutrition)<br>* 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.<br>|
| Experimental: Lifestyle counseling (physical activity)<br>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. | Behavioral: Lifestyle intervention (physical activity)<br>* 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.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| The proportion of patients who reach normal levels of all glycaemic parameters. | Proportion of patients whose fasting glucose level is less than 6.1 mmol/l Proportion of patients whose 2-hour glucose level is less than 7.8 mmol/l | Month 24 of the intervention | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Difference in reduction of 10 year-estimated cardiovascular risk score of 10% between the standard therapy control group and the lifestyle intervention groups (WHO CVD prediction chart). | Proportion of patients whose blood pressure level is less than 130/80 mmHg Proportion of patients whose serum HDL cholesterol level is more than 1.2 mmol/l Proportion of patients whose serum LDL cholesterol level is less than 2.0 mmol/l Proportion of patients whose total/HDL cholesterol ratio is less than 4.0 Proportion of patients whose weight reduction is more than 5% | Month 24 of the intervention | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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impaired glucose tolerance, nutrition, physical activity