- ICH GCP
- Amerikanska kliniska prövningsregistret
- Klinisk prövning NCT01296100
DEMOJUAN- DEMOnstration Area for Primary Prevention of Type 2 Diabetes, JUAN Mina and Barranquilla, Colombia (DEMOJUAN)
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.
Studieöversikt
Status
Betingelser
Intervention / Behandling
Detaljerad beskrivning
Studietyp
Inskrivning (Faktisk)
Fas
- Inte tillämpbar
Kontakter och platser
Studieorter
-
-
-
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
-
-
Deltagandekriterier
Urvalskriterier
Åldrar som är berättigade till studier
Tar emot friska volontärer
Kön som är behöriga för studier
Beskrivning
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
Hur är studien utformad?
Designdetaljer
- Primärt syfte: Förebyggande
- Tilldelning: Randomiserad
- Interventionsmodell: Enskild gruppuppgift
- Maskning: Ingen (Open Label)
Vapen och interventioner
Deltagargrupp / Arm |
Intervention / Behandling |
|---|---|
|
Experimentell: 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.
|
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.
|
|
Experimentell: 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.
|
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.
|
Vad mäter studien?
Primära resultatmått
Resultatmått |
Åtgärdsbeskrivning |
Tidsram |
|---|---|---|
|
The proportion of patients who reach normal levels of all glycaemic parameters.
Tidsram: Month 24 of the intervention
|
|
Month 24 of the intervention
|
Sekundära resultatmått
Resultatmått |
Åtgärdsbeskrivning |
Tidsram |
|---|---|---|
|
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).
Tidsram: Month 24 of the intervention
|
|
Month 24 of the intervention
|
Samarbetspartners och utredare
Utredare
- Huvudutredare: Jaakko O Tuomilehto, MD, PhD, University of Helsinki
- Studiestol: Tania Acosta, MD, CIIS LTDA
- Studiestol: Noël C Barengo, MD, PhD, MPH, CIIS LTDA
- Studierektor: Astrid Arrieta, MD, CIIS LTDA
- Studiestol: Carlos Ricaurte, CIIS LTDA
Publikationer och användbara länkar
Allmänna publikationer
- 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.
- 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.
- 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.
- 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.
Användbara länkar
Studieavstämningsdatum
Studera stora datum
Studiestart
Primärt slutförande (Faktisk)
Avslutad studie (Faktisk)
Studieregistreringsdatum
Först inskickad
Först inskickad som uppfyllde QC-kriterierna
Första postat (Uppskatta)
Uppdateringar av studier
Senaste uppdatering publicerad (Uppskatta)
Senaste inskickade uppdateringen som uppfyllde QC-kriterierna
Senast verifierad
Mer information
Termer relaterade till denna studie
Nyckelord
Ytterligare relevanta MeSH-villkor
Andra studie-ID-nummer
- LT09-258
Plan för individuella deltagardata (IPD)
Planerar du att dela individuella deltagardata (IPD)?
IPD-planbeskrivning
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