Primary objective:- to determine the association of the intra-individual determinants and the physical environment in regulating lifestyle behaviour and in turn the occurrence of pre-T2D and T2D in the general population. Secondary Objective(s): -…
ID
Source
Brief title
Condition
- Cardiac disorders, signs and symptoms NEC
- Glucose metabolism disorders (incl diabetes mellitus)
- Mood disorders and disturbances NEC
Synonym
Research involving
Sponsors and support
Intervention
Outcome measures
Primary outcome
The primary endpoint is incident (pre)T2D, measured by using a fasting blood
samples as well as blood taken during an Oral Glucose Tolerance Test.
Secondary outcome
T2D complications including:
- Medication use;
- Frailty;
- Blood pressure, hypertension;
- Psychological complications: depression, anxiety, sleep problems, fatigue,
pain, physical functioning and participating social roles, aggression and
emtional support;
- Dental health;
- Quality of life;
- Occurence of cardiovascular disease;
- All-cause and cause-specific mortality.
Background summary
Although prevention programmes show that lifestyle modification is effective to
prevent type 2 diabetes (T2D), the general population is largely unable to
adopt a healthy lifestyle. Moreover, such prevention programs are ineffective
to maintain over a longer period of time. More insight is needed in the
determinants of adoption of a healthy lifestyle and their role in disturbance
of glucose metabolism and T2D risk. Theoretical models such as the
socio-ecological model provide insights in such upstream determinants of
lifestyle behaviours, for example motivation. Despite this, very few studies
have actually investigated the association of more upstream factors with
disease outcomes and whether this potential association can be explained by
health behaviours. More insight in these associations can provide insights for
prevention programs to address these underlying factors or identify those at
high risk to develop T2D. The Hoorn study is a longstanding population-based
cohort study with the primary aim to investigate the prevalence and risk
factors of T2D. The Hoorn study was initiated in 1989 and since then several
additional follow-up rounds have been conducted, also with sampling of new
participants in 2007. Therefore, the Hoorn study provides an excellent
opportunity to address these research questions.
Study objective
Primary objective:
- to determine the association of the intra-individual determinants and
the physical environment in regulating lifestyle behaviour and in turn the
occurrence of pre-T2D and T2D in the general population.
Secondary Objective(s):
- To determine the association between the intra-individual determinants and
physical environment with secondary outcomes of the individual continuous
measures of glucose metabolism (glucose, insulin, insulin sensitivity) in the
general population;
- To determine the association between the intra-individual determinants and
physical environment with secondary outcomes of obesity in the general
population;
- To determine the association between the intra-individual determinants and
physical environment determinants and complications of T2D, such as
cardiovascular disease and psychological problems in the general population;
- To determine the mediation effect of the lifestyle behaviours in the
association between intra-individual determinants and physical environment and
glucose metabolism in the general population.
Study design
Prospective cohort study.
Study burden and risks
Participants are asked to visit the research institute 1 time. This takes in
total 5 hours. Several non-invasive questionnaires are taken. Anthropometry and
blood pressure are determined. During the first visit (4 hours), an oral
glucose tolerance test (OGTT) is administered in those without diabetes. All
participants are requested to fast before they come to the research center
(starting 10pm the evening before the study; and to refrain from alcohol from 5
pm the evening before the study), participants are allowed to drink water.
Blood is taken. Participants are also asked to bring a urine and faeces sample.
All participants are asked to wear an accelerometer for a week.
Participants with diabetes are asked to take a Walking Speed Test.
Van der Boechorststraat 7
Amsterdam 1081 BT
NL
Van der Boechorststraat 7
Amsterdam 1081 BT
NL
Listed location countries
Age
Inclusion criteria
All surviving subjects who participated in the New Hoorn Study in 2006-2008
will be invited.
All participants who provided informed consent to be contacted again for
additional follow up.
Exclusion criteria
Unable to give written informed consent.
Serious mental impairment i.e. preventing to understand the study protocol/aim.
Design
Recruitment
Medical products/devices used
Followed up by the following (possibly more current) registration
No registrations found.
Other (possibly less up-to-date) registrations in this register
No registrations found.
In other registers
Register | ID |
---|---|
ISRCTN | ISRCTN31493512 |
CCMO | NL74969.029.21 |