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

This study is ongoing, but not recruiting participants.
Sponsor:
Collaborators:
International Diabetes Federation
Universidad Libre, Barranquilla, Colombia
Helsinki University
Secretaria de Salud, Barranquilla, Colombia
Information provided by:
Centro de Investigacion Sanitaria
ClinicalTrials.gov Identifier:
NCT01296100
First received: February 12, 2011
Last updated: April 3, 2013
Last verified: April 2013
  Purpose

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.


Condition Intervention
Type 2 Diabetes
Glucose Metabolism Disorders
Behavioral: Lifestyle intervention (nutrition)
Behavioral: Lifestyle intervention (physical activiy)

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Prevention
Official Title: DEMOnstration Area for Primary Prevention of Type 2 Diabetes, JUAN Mina and Barranquilla, Colombia

Resource links provided by NLM:


Further study details as provided by Centro de Investigacion Sanitaria:

Primary Outcome Measures:
  • The proportion of patients who reach normal levels of all glycaemic parameters. [ Time Frame: Month 24 of the intervention ] [ Designated as safety issue: No ]
    • 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


Secondary Outcome Measures:
  • 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). [ Time Frame: Month 24 of the intervention ] [ Designated as safety issue: No ]
    • 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%


Estimated Enrollment: 600
Study Start Date: February 2011
Estimated Study Completion Date: March 2015
Estimated Primary Completion Date: March 2015 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Lifestyle intervention (nutrition)
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)
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.
Experimental: Lifestyle counseling (physical activity)
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 activiy)
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.

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

Ages Eligible for Study:   34 Years to 69 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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.
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01296100

Locations
Colombia
Centro de INvestigacion Sanitaria
Barranquilla, Colombia
Paso Nueva Era
Barranquilla, Colombia
Paso Las Malvinas
Barranquilla, Colombia
Camino Sur Occidente El Pueblo
Barranquilla, Colombia
Camino Bosques de María
Barranquilla, Colombia
Sponsors and Collaborators
Centro de Investigacion Sanitaria
International Diabetes Federation
Universidad Libre, Barranquilla, Colombia
Helsinki University
Secretaria de Salud, Barranquilla, Colombia
Investigators
Principal Investigator: Jaakko O Tuomilehto, MD, PhD Helsinki University
Study Chair: Tania Acosta, MD CIIS LTDA
Study Chair: Noël C Barengo, MD, PhD, MPH CIIS LTDA
Study Director: Astrid Arrieta, MD CIIS LTDA
Study Chair: Carlos Ricaurte CIIS LTDA
  More Information

Additional Information:
Publications:
Responsible Party: Professor Jaakko Tuomilehto, University of Helsinki
ClinicalTrials.gov Identifier: NCT01296100     History of Changes
Other Study ID Numbers: LT09-258
Study First Received: February 12, 2011
Last Updated: April 3, 2013
Health Authority: Colombia: Institutional Review Board

Keywords provided by Centro de Investigacion Sanitaria:
diabetes, impaired glucose tolerance, hyperlipidemia, nutrition, physical activity

Additional relevant MeSH terms:
Diabetes Mellitus
Diabetes Mellitus, Type 2
Metabolic Diseases
Glucose Metabolism Disorders
Endocrine System Diseases

ClinicalTrials.gov processed this record on August 20, 2014