Aim of the Maastricht StudyThe primary objectives of the Maastricht Study are:1. to study the development of obesity, the metabolic syndrome and type 2diabetes in the general population.2. to study the development of cardiovascular disease in theā¦
ID
Source
Brief title
Condition
- Heart failures
- Diabetic complications
- Glucose metabolism disorders (incl diabetes mellitus)
Synonym
Research involving
Sponsors and support
Intervention
Outcome measures
Primary outcome
The covering structure of the Maastricht Study can then be described along 7
separate research lines that are highly interrelated:
A. Diabetes, pre-diabetes and the metabolic syndrome
Focus: the implementation of novel techniques to study glucose tolerance status
/ the metabolic syndrome in relation to the development of both micro- and
macro cardiovascular disease.
B. Cardiovascular Imaging
Focus: the implementation of techniques to study structure and function of the
central and peripheral circulation and, their relationship with any of the
study endpoints
C. Neurological Diseases
Focus: the implementation of techniques to study structure and function of the
central and peripheral nervous system and, their relationship with any of the
study endpoints
D. Respiratory Diseases and other co-morbidities
Focus: the implementation of spirometry and ambulatory respiratory monitoring,
gastro-intestinal disease and, their relationship with any of the study
endpoints
E. Lifestyle & Behavioural Studies
Focus: the implementation of questionnaires and function tests that provide
information about diet, exercise and illness behaviour / coping mechanisms in
chronic disease and, their relationship with study endpoints (including
muscular-skeletal diseases).
F. Public Health
Focus: the collection of demographic as well as socio-demographic data; in
addition a repetitive morbidity and mortality surveillance will be held on all
participants
G. Biomarker Collection & Biobanking
Focus: establishment of a biobank, which includes blood-, urine-, faeces- and
DNA - sampling. In addition to the collection of microbial nasal swabs and
respiratory air samples.
Endpoints & Determinants
The study can be described in term of study endpoints which are based upon on
the International Classification of Diseases version 10 (ICD-10 codes) and
include:
A: Diabetes, pre-diabetes and the metabolic syndrome
- E11 Type 2 Diabetes
- Subcutaneous and visceral fat
- Ectopic fat in liver and pancreas
B: Cardiovascular Imaging
- I10-15 Hypertensive Disease
- 20-25 Ischemic Heart Disease
- I42-44; I47-51 Other Forms of Heart Disease
- I26 Pulmonary Embolism
- I73.9; I79.2 Peripheral Artery Disease
- I80.1-3 Deep Venous Thrombosis
C: Neurological Diseases
- I61; 63; 64 Cerebrovascular Disease
- G43 Migraine
- F00-01 Dementia
- F32 Depression
- H90; 93.1 Diseases of the Ear
- H25; 28; 35.8; 36; 40; 54 Diseases of the Eye
- G99; 63.3 Neuropathy
- Cerebral small vessel disease
- Cerebral connectivity
D: Respiratory Diseases and other co-morbidities
- G47.3 Sleep Apnoea
- J41; 42; 44 Respiratory Disease
E: Lifestyle & Behavioural Studies
- M10 Gout
- S02; 12; 22; 32; 42; 52; 62; 72; 82; 92 Fractures
- T02; 08; 10; 12; 14.2; 93.2 Fractures
- M80-82; 84 Osteoporosis
- S91 Ulceration of the Foot or Ankle
Secondary outcome
not applicable (yet)
Background summary
In the Western world, the prevalence of obesity is increasing at an alarming
rate. Consequently, the prevalence of the metabolic syndrome, type 2 diabetes
and cardiovascular disease is increasing. A particular alarming phenomenon is
that the occurrence of obesity shifts towards younger generations (<50 years)
in an ageing population (currently 51% of the Dutch adult population is
moderately to severely overweight (BMI >= 25 kg/m2). In addition, it has become
increasingly clear that the presence of obesity not only precedes the
development of the metabolic syndrome, type 2 diabetes and cardiovascular
disease but also of many other chronic illnesses (such as osteoporosis,
depression, dementia and chronic lung disease) and that particularly the
presence of type 2 diabetes seems to accelerate the development of other
chronic illnesses.
The above will most certainly have an important impact on society, future
health care and the individual patient. Yet, the underlying pathophysiology of
the above phenomena is only partially understood. It is therefore of paramount
importance to come to a better understanding of the pathophysiology of obesity,
the metabolic syndrome and type 2 diabetes in order to withstand the increasing
demands of the obesity epidemic upon society.
Study objective
Aim of the Maastricht Study
The primary objectives of the Maastricht Study are:
1. to study the development of obesity, the metabolic syndrome and type 2
diabetes in the general population.
2. to study the development of cardiovascular disease in the general population
and how diabetes and the metabolic syndrome accelerate this.
3. to study the clustering of other chronic diseases in the general population
and
how diabetes and the metabolic syndrome accelerate this.
4. to identify novel biomarkers or risk factors in order to facilitate the
identification of the high-risk patient which would benefit most from early
intervention.
Study design
The Maastricht Study is closely intertwined with the Pearl String Initiative on
Diabetes (het Parelsnoer Initiatief (*Diabetes Parel*); METC 09/107) and The
Maastricht Study will act as covering structure. In short, the aim of the
Pearl String Initiative on Diabetes (Appendix III) is to set up a nation-wide
diabetes biobank of individuals with type 2 diabetes in order to identify risk
markers for cardiovascular and diabetes-related complications and to evaluate
the effectiveness of therapy and medication. The data set is oriented towards
the prediction of cardiovascular morbidity and mortality (METC 09/107). The
Maastricht Study will expand this initiative by additional phenotyping of all
Pearl Sting Initiative participants (n = 3000), by sampling an additional
cohort of 2000 Maastricht Study participants with type 2 diabetes and by
sampling a cohort of 5000 Maastricht Study participants without type 2 diabetes
(Figure 1). Of note: all Pearl String participants will be asked to give
informed consent to participate in the Maastricht Study separately from the
Pearl String Initiative.
Study burden and risks
Nature and extent of the burden and risks associated with participation,
benefit and group relatedness: Participation involves four site visits, in
which a detailed health check is conducted. The detailed assessment of health
status may reveal prevalent disease in a preclinical and/or asymptomatic stage.
On the one hand, awareness of normally unknown pathology may affect a person*s
perception of his own health condition negatively. On the other hand, early
detection is likely to have favourable effects on disease progression and
enable early intervention. Each participant will receive an individual
lifestyle advice on how to improve his or her health.
p. debyelaan 25 / postbus 2500
6202 ZA Maastricht
NL
p. debyelaan 25 / postbus 2500
6202 ZA Maastricht
NL
Listed location countries
Age
Inclusion criteria
participant should be an inhabitant of Maastricht and Heuvelland region and between 40 to 75 years of age. Moreover, all participants need to have normal mental capacities and be legally not restricted in any way.
Addititional inclusion criteria for the diabetes subgroup are diagnosed type 2 diabetes according to GP criteria or fasting circulating levels of glucose of 6.1 mmol/L or more or circulating levels of 10.0 mmol/L or more after 2-hours glucose load (oral glucose tolerance test).[33]
Exclusion criteria
None, except for nursing home residency, hospital or psychiatric institute admission and (severe) cognitive limitations which interferes with any of the procedures to obtain informed consent according to the Helsinki declaration.
Design
Recruitment
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 |
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CCMO | NL31329.068.10 |