Clinical trial NCT01296100: DEMOJUAN- DEMOnstration Area for Primary Prevention of Type 2 Diabetes, JUAN Mina and Barranquilla, Colombia
Official title: DEMOnstration Area for Primary Prevention of Type 2 Diabetes, JUAN Mina and Barranquilla, Colombia
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Type 2 Diabetes
Glucose Metabolism Disorders
Keywords: impaired glucose tolerance
nutrition
physical activity
Lead sponsor: Centro de Investigacion Sanitaria
Sponsor class: NETWORK
Collaborators: name: International Diabetes Federation
name: University of Helsinki
First posted: 2011-02-15
Enrollment: 730
Sex: ALL
Minimum age (years): 34
Maximum age (years): 69
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: SINGLE_GROUP
Primary purpose: PREVENTION

Brief 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.

Eligibility criteria: 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.

Primary outcomes:
measure: The proportion of patients who reach normal levels of all glycaemic parameters.
timeFrame: Month 24 of the intervention
Secondary outcomes:
measure: 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).
timeFrame: Month 24 of the intervention
Other outcomes:
Locations:
city: Barranquilla
country: Colombia
facility: Camino Bosques de María
city: Barranquilla
country: Colombia
facility: Camino Sur Occidente El Pueblo
city: Barranquilla
country: Colombia
facility: Centro de INvestigacion Sanitaria
city: Barranquilla
country: Colombia
facility: Paso Las Malvinas
city: Barranquilla
country: Colombia
facility: Paso Nueva Era
Study officials:
affiliation: University of Helsinki
name: Jaakko O Tuomilehto, MD, PhD
role: PRINCIPAL_INVESTIGATOR
affiliation: CIIS LTDA
name: Tania Acosta, MD
role: STUDY_CHAIR
affiliation: CIIS LTDA
name: Noël C Barengo, MD, PhD, MPH
role: STUDY_CHAIR
affiliation: CIIS LTDA
name: Astrid Arrieta, MD
role: STUDY_DIRECTOR
affiliation: CIIS LTDA
name: Carlos Ricaurte
role: STUDY_CHAIR
References:
citation: Schwarz PE, Li J, Lindstrom J, Tuomilehto J. Tools for predicting the risk of type 2 diabetes in daily practice. Horm Metab Res. 2009 Feb;41(2):86-97. doi: 10.1055/s-0028-1087203. Epub 2008 Nov 19.
citation: Lindstrom J, Peltonen M, Eriksson JG, Aunola S, Hamalainen H, Ilanne-Parikka P, Keinanen-Kiukaanniemi S, Uusitupa M, Tuomilehto J; Finnish Diabetes Prevention Study (DPS) Group. Determinants for the effectiveness of lifestyle intervention in the Finnish Diabetes Prevention Study. Diabetes Care. 2008 May;31(5):857-62. doi: 10.2337/dc07-2162. Epub 2008 Feb 5.
citation: Lindstrom J, Louheranta A, Mannelin M, Rastas M, Salminen V, Eriksson J, Uusitupa M, Tuomilehto J; Finnish Diabetes Prevention Study Group. The Finnish Diabetes Prevention Study (DPS): Lifestyle intervention and 3-year results on diet and physical activity. Diabetes Care. 2003 Dec;26(12):3230-6. doi: 10.2337/diacare.26.12.3230.
citation: Acosta T, Barengo NC, Arrieta A, Ricaurte C, Tuomilehto JO. A demonstration area for type 2 diabetes prevention in Barranquilla and Juan Mina (Colombia): Baseline characteristics of the study participants. Medicine (Baltimore). 2018 Jan;97(1):e9285. doi: 10.1097/MD.0000000000009285.