Type 2 DiabetesDEMOJUANNCT01296100
DEMOJUAN- DEMOnstration Area for Primary Prevention of Type 2 Diabetes, JUAN Mina and Barranquilla, Colombia
A study testing Lifestyle intervention (nutrition) and Lifestyle intervention (physical activity) in people with Type 2 Diabetes and Glucose Metabolism Disorders, run by Centro de Investigacion Sanitaria at 5 sites in Colombia.
Trial 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. Read more about this study
- Who is it for?
- Ages 34 to 69 years
- Conditions the study is for
- Type 2 Diabetes, Glucose Metabolism Disorders
- What is being tested?
- Lifestyle intervention (nutrition) and Lifestyle intervention (physical activity)
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 730 participants
- Where
- 5 sitesColombia
- Study dates
- Feb 2011to Mar 2015
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 34 to 69 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 34-69 years-of-age with diagnosed IGT
- Informed consent given.
Who cannot join
- Patients with pharmacologically-treated diabetes
- Hypertriglyceridaemia under drug treatment
- History of life-limiting diseases or events
- Unwillingness to sign the informed consent.
Trial locations and contacts
5 sites in 1 country.
5 sites in 1 country
Colombia5 sites
Camino Bosques de María
Barranquilla, Barranquilla
Camino Sur Occidente El Pueblo
Barranquilla, Barranquilla
Centro de INvestigacion Sanitaria
Barranquilla, Barranquilla
Paso Las Malvinas
Barranquilla, Barranquilla
Paso Nueva Era
Barranquilla, Barranquilla
About this study
Official title: DEMOnstration Area for Primary Prevention of Type 2 Diabetes, JUAN Mina and Barranquilla, Colombia
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.
Read the 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.
- Conditions
- Type 2 Diabetes, Glucose Metabolism Disorders
- Being tested
- Lifestyle intervention (nutrition), Lifestyle intervention (physical activity)
- Keywords
- impaired glucose tolerance, nutrition, physical activity
- Medical subject headings
- Diabetes Mellitus, Type 2, Glucose Metabolism Disorders, Glucose Intolerance, Motor Activity
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Lifestyle intervention (nutrition)Behavioural
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.
Lifestyle intervention (physical activity)Behavioural
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.
| Study group | Role | What they receive |
|---|---|---|
| Lifestyle intervention (nutrition) | Experimental | 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. Receives: Behavioral: Lifestyle intervention (nutrition) |
| Lifestyle counseling (physical activity) | Experimental | 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. Receives: Behavioral: Lifestyle intervention (physical activity) |
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Measured: Month 24 of the intervention
Secondary outcomes (1)
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%
Measured: Month 24 of the intervention
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted15 Feb 2011 (estimated)
- Study startFeb 2011
- Primary completionJan 2013
- Study completionMar 2015
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (4)Papers the sponsor has linked to this study.
- Other trials for Type 2 DiabetesStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 730 participants (actual)
Sponsor and investigators
- Lead sponsor
- Centro de Investigacion Sanitaria
- Sponsor type
- Research network
- Collaborators
- International Diabetes Federation, University of Helsinki
- Responsible party
- Sponsor
- Investigators
- Jaakko O Tuomilehto, MD, PhD, Principal investigator, University of HelsinkiTania Acosta, MD, Study chair, CIIS LTDANoël C Barengo, MD, PhD, MPH, Study chair, CIIS LTDAAstrid Arrieta, MD, Study director, CIIS LTDACarlos Ricaurte, Study chair, CIIS LTDA
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01296100
- Sponsor's protocol ID
- LT09-258
- Acronym
- DEMOJUAN
- Status last verified
- Jul 2016
- First submitted
- 12 Feb 2011
- Last updated
- 26 Jul 2016
- Results posted
- No
- Data monitoring committee
- No
- Individual data sharing
- Yes: The study group is ready to share the data in de-identified format once the main results have been reported or in case any journal may ask for the data to run a check.
Publications
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.
PubMed 19021089Lindstrom 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.
PubMed 18252900Lindstrom 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.
PubMed 14633807Acosta 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.
PubMed 29505512
Study at a glance
From the registry record, last updated by the sponsor on 26 Jul 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- DEMOnstration Area for Primary Prevention of Type 2 Diabetes, JUAN Mina and Barranquilla, Colombia
- ClinicalTrials.gov ID
- NCT01296100
- Acronym / sponsor ID
- DEMOJUAN / LT09-258
- Conditions
- Type 2 Diabetes, Glucose Metabolism Disorders
- Keywords
- impaired glucose tolerance, nutrition, physical activity
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 730 participants (actual)
- Lead sponsor
- Centro de Investigacion SanitariaResearch network
- Collaborators
- International Diabetes Federation, University of Helsinki
- Study start
- Feb 2011
- Primary completion
- Jan 2013 (actual)
- Study completion
- Mar 2015 (actual)
- First posted
- 15 Feb 2011 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Lifestyle intervention (nutrition) | Experimental | 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. |
| Lifestyle counseling (physical activity) | Experimental | Behavioral: Lifestyle intervention (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. |
Who may qualify
- Ages
- 34 to 69 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- 34-69 years-of-age with diagnosed IGT
- Informed consent given.
Key exclusion criteria (4 listed)
- Patients with pharmacologically-treated diabetes
- Hypertriglyceridaemia under drug treatment
- History of life-limiting diseases or events
- Unwillingness to sign the informed consent.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| 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. | Behavioural | Lifestyle intervention (nutrition) |
| Lifestyle intervention (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. | Behavioural | Lifestyle counseling (physical activity) |
Primary outcome
The proportion of patients who reach normal levels of all glycaemic parameters.
Time frame: Month 24 of the intervention
* 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
1 secondary outcome
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
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 26 Jul 2016.
- Background: PubMed 19021089Schwarz 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.
- Background: PubMed 18252900Lindstrom 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.
- Background: PubMed 14633807Lindstrom 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.
- Derived from this study: PubMed 29505512Acosta 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.
- Related InfoLink provided by the sponsor.
- Individual participant dataSharing planned: Yes. The study group is ready to share the data in de-identified format once the main results have been reported or in case any journal may ask for the data to run a check.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Jaakko O Tuomilehto, MD, PhD principal investigator
University of Helsinki
Tania Acosta, MD study chair
CIIS LTDA
Noël C Barengo, MD, PhD, MPH study chair
CIIS LTDA
5 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Lifestyle intervention (nutrition) and Lifestyle intervention (physical activity) in people with Type 2 Diabetes and Glucose Metabolism Disorders, run by Centro de Investigacion Sanitaria at 5 sites in Colombia.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 26 Jul 2016. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 5 sites in Colombia. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
The proportion of patients who reach normal levels of all glycaemic parameters. (time frame: Month 24 of the intervention). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT01296100, which also lists 4 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 26 Jul 2016.