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

25. juli 2016 opdateret af: Centro de Investigacion Sanitaria

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.

Studieoversigt

Status

Afsluttet

Betingelser

Intervention / Behandling

Detaljeret beskrivelse

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.

Undersøgelsestype

Interventionel

Tilmelding (Faktiske)

730

Fase

  • Ikke anvendelig

Kontakter og lokationer

Dette afsnit indeholder kontaktoplysninger for dem, der udfører undersøgelsen, og oplysninger om, hvor denne undersøgelse udføres.

Studiesteder

  • Colombia
      • Barranquilla, Colombia
        • Camino Bosques de María
      • Barranquilla, Colombia
        • Camino Sur Occidente El Pueblo
      • Barranquilla, Colombia
        • Centro de INvestigacion Sanitaria
      • Barranquilla, Colombia
        • Paso Las Malvinas
      • Barranquilla, Colombia
        • Paso Nueva Era

Deltagelseskriterier

Forskere leder efter personer, der passer til en bestemt beskrivelse, kaldet berettigelseskriterier. Nogle eksempler på disse kriterier er en persons generelle helbredstilstand eller tidligere behandlinger.

Berettigelseskriterier

Aldre berettiget til at studere

34 år til 69 år (Voksen, Ældre voksen)

Tager imod sunde frivillige

Ingen

Køn, der er berettiget til at studere

Alle

Beskrivelse

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.

Studieplan

Dette afsnit indeholder detaljer om studieplanen, herunder hvordan undersøgelsen er designet, og hvad undersøgelsen måler.

Hvordan er undersøgelsen tilrettelagt?

Design detaljer

  • Primært formål: Forebyggelse
  • Tildeling: Randomiseret
  • Interventionel model: Enkelt gruppeopgave
  • Maskning: Ingen (Åben etiket)

Våben og indgreb

Deltagergruppe / Arm
Intervention / Behandling
Eksperimentel: 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.
Adfærdsmæssigt: 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.
Eksperimentel: 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.
Adfærdsmæssigt: 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.

Hvad måler undersøgelsen?

Primære resultatmål

Resultatmål
Foranstaltningsbeskrivelse
Tidsramme
The proportion of patients who reach normal levels of all glycaemic parameters.
Tidsramme: 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
Month 24 of the intervention

Sekundære resultatmål

Resultatmål
Foranstaltningsbeskrivelse
Tidsramme
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).
Tidsramme: Month 24 of the intervention
  • 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

Samarbejdspartnere og efterforskere

Det er her, du vil finde personer og organisationer, der er involveret i denne undersøgelse.

Sponsor

Centro de Investigacion Sanitaria

Samarbejdspartnere

University of Helsinki
International Diabetes Federation

Efterforskere

  • Ledende efterforsker: Jaakko O Tuomilehto, MD, PhD, University of Helsinki
  • Studiestol: Tania Acosta, MD, CIIS LTDA
  • Studiestol: Noël C Barengo, MD, PhD, MPH, CIIS LTDA
  • Studieleder: Astrid Arrieta, MD, CIIS LTDA
  • Studiestol: Carlos Ricaurte, CIIS LTDA

Publikationer og nyttige links

Den person, der er ansvarlig for at indtaste oplysninger om undersøgelsen, leverer frivilligt disse publikationer. Disse kan handle om alt relateret til undersøgelsen.

Generelle publikationer

Hjælpsomme links

Datoer for undersøgelser

Disse datoer sporer fremskridtene for indsendelser af undersøgelsesrekord og resumeresultater til ClinicalTrials.gov. Studieregistreringer og rapporterede resultater gennemgås af National Library of Medicine (NLM) for at sikre, at de opfylder specifikke kvalitetskontrolstandarder, før de offentliggøres på den offentlige hjemmeside.

Studer store datoer

Studiestart

1. februar 2011

Primær færdiggørelse (Faktiske)

1. januar 2013

Studieafslutning (Faktiske)

1. marts 2015

Datoer for studieregistrering

Først indsendt

12. februar 2011

Først indsendt, der opfyldte QC-kriterier

14. februar 2011

Først opslået (Skøn)

15. februar 2011

Opdateringer af undersøgelsesjournaler

Sidste opdatering sendt (Skøn)

26. juli 2016

Sidste opdatering indsendt, der opfyldte kvalitetskontrolkriterier

25. juli 2016

Sidst verificeret

1. juli 2016

Mere information

Begreber relateret til denne undersøgelse

Nøgleord

Yderligere relevante MeSH-vilkår

Andre undersøgelses-id-numre

  • LT09-258

Plan for individuelle deltagerdata (IPD)

Planlægger du at dele individuelle deltagerdata (IPD)?

JA

IPD-planbeskrivelse

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.

Disse oplysninger blev hentet direkte fra webstedet clinicaltrials.gov uden ændringer. Hvis du har nogen anmodninger om at ændre, fjerne eller opdatere dine undersøgelsesoplysninger, bedes du kontakte register@clinicaltrials.gov. Så snart en ændring er implementeret på clinicaltrials.gov, vil denne også blive opdateret automatisk på vores hjemmeside .

Kliniske forsøg med Lifestyle intervention (nutrition)

Søg i lignende forsøg

Sponsorer og samarbejdspartnere

Medicinske tilstande

Narkotikainterventioner

CROs by country

CROs in Austria

Betingelser

Sjældne sygdomme

Narkotikainterventioner

Kosttilskud

Sponsor / samarbejdspartnere

Placeringer

Abonner