|- candidate number||2724|
|- NTR Number||NTR1050|
|- ISRCTN||ISRCTN wordt niet meer aangevraagd|
|- Date ISRCTN created|
|- date ISRCTN requested|
|- Date Registered NTR||4-sep-2007|
|- Secondary IDs||6130.0034 Zonmw |
|- Public Title||Diabetes intervention study in Hindustani Surinamese|
|- Scientific Title||Screening for (pre)diabetes followed by a targeted lifestyle intervention to prevent diabetes mellitus among young and middle-aged Hindustani Surinamese: a feasibility study. |
|- hypothesis||A systematic screening and a lifestyle-intervention for pre-diabetes targeted at the Hindustani Surinamese population will prevent or postpone the onset of diabetes mellitus type 2. |
|- Healt Condition(s) or Problem(s) studied||Diabetes Mellitus Type 2 (DM type II)|
|- Inclusion criteria||Inclusion criteria screening:|
1. Hindustani Surinamese background;
2. Aged between 18-60 years.
Inclusion criteria intervention:
1. Hindustani Surinamese background;
2. Aged between 18-60 years;
3. Persons found to have prediabetes during the screening.
|- Exclusion criteria||Exclusion criteria screening:|
1. Known diabetes patients.
Exclusion criteria intervention:
1. Persons found to have diabetes during the screening;
2. Any chronic illness that makes participation during lifestyle-intervention impossible;
3. Medication known to interfere with glucose tolerance;
4. Participation in a regular vigorous exercise and/or diet program.
|- mec approval received||yes|
|- multicenter trial||yes|
|- planned startdate ||1-okt-2007|
|- planned closingdate||1-sep-2008|
|- Target number of participants||1500|
|- Interventions||Lifestyle intervention, which consists of dietary counseling and supervised physical activity.|
|- Primary outcome||1. Normal blood glucose values;
2. Prediabetes (impaired fasting glucose and impaired glucose tolerance);
|- Secondary outcome||1. Views on the screening;
2. Views on the intervention.|
|- Trial web site||http://www.amc.nl/dhiaan|
|- status||stopped: trial finished|
|- CONTACT FOR PUBLIC QUERIES|| Wietske Hoekstra|
|- CONTACT for SCIENTIFIC QUERIES||Prof. dr. K. Stronks|
|- Sponsor/Initiator ||Academic Medical Centre (AMC), Dept of Social Medicine|
(Source(s) of Monetary or Material Support)
|ZON-MW, The Netherlands Organization for Health Research and Development|
|- Brief summary||Background
Type 2 diabetes mellitus (DM) is highly prevalent among the Hindustani Surinamese; 30% in the group 45-60 years. This group is not only younger at presentation, but also at high risk of developing CVD. Early detection and treatment of DM may decrease the risk of complications. The objective of this study is to develop a screening program and lifestyle intervention for Hindustani Surinamese, aimed at identifying pre-diabetes and preventing DM.
Screening: 1500 Hindustani Surinamese in The Hague, aged 18 to 60 years, will be randomized to a standard or intensive recruitment strategy. Participants will be asked to donate a fasting blood sample and an oral glucose tolerance test will be carried out.
Intervention: Persons found to have impaired fasting glucose (fasting plasma glucose 5.6-< 7.0mmol/l) or impaired glucose tolerance (2-hour post-load glucose ¡Ý7.8-<11.1mmol/l) will be invited to participate in the intervention; they will be randomized to the lifestyle intervention or control group.
The content of the intervention is based on previous lifestyle interventions and will be targeted to the Hindustani Surinamese. Data on physical activity and dietary habits in the Hindustani Surinamese population are available from the SUNSET-study. A process evaluation among Surinamese participants in a physical exercise programme will provide insight into determinants of physical activity. Additional focus group discussions will take place among Hindustani Surinamese to gain further insight in determinants of physical activity and healthy dietary habits.
The full design of the screening will be presented. Moreover, we will discuss the content of the the lifestyle intervention, including the results of the SUNSET data and the focus group discussions.
If the screening and lifestyle intervention are found to be feasible, a larger intervention study will be set up in order to determine the effectiveness of the screening followed by the intervention.
|- Main changes (audit trail)||The initially planned randomised controlled trial of the lifestyle intervention was postphoned (NTR1499). Therefore the number of persons to be included in the initial evaluation was changed from 1500 to 878.|
|- RECORD||4-sep-2007 - 12-sep-2012|