In the current study we will re-examine the participants of the CODAM study in a second follow-up evaluation (12 yrs after baseline) in order to obtain further longitudinal information on the natural development of type 2 diabetes and cardiovascular…
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
(1) Development and progression of insulin resistance, glucose intolerance and
type 2 diabetes in the CODAM study population.
(2) Development and progression of atherosclerosis, vascular dysfunction and
CVD in the CODAM study population.
Specific outcomes:
- International Classification of Diseases version 10 (ICD-10 codes) :
E11 (type 2 diabetes)
I10-15 (hypertensive disease)
I20-25 (ischaemic heart disease)
- Subcutaneous and visceral fat
- Ectopic fat in the liver
- insulin resistance and glucose tolreance status
- Measures of arterial structure (including carotid Intima-Media-Thikcness &
Ankle-Brachial Index) and function (including arterial stiffness)
- Presence of Metabolic Syndrome (according to the most recent defintion of
Alberti et al (2009))
Secondary outcome
(1) Mortality
(2) Liver enzymes (reflecting progression of NAFLD).
(3) Adiposity (BMI, waist-to-hip ratio, waist circumference, skinfold thickness)
(4) Gene expression, biomarkers and/or genetic variations; differences between
subjects with and whithout (incident) T2DM
(5) Gene expression, biomarkers and/or genetic variations;differences between
subjects with and whithout (incident) CVD
Outcomes of the Maastriccht studie for as far as these are not included in the
primary outomes of the CODAM study. 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:
Diabetes, pre-diabetes and the metabolic syndrome
- Ectopic fat in the pancreas
Cardiovascular Imaging
- 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
Background summary
Despite progress in our understanding of the development of cardiometabolic
diseases, including type 2 diabetes and cardiovascular disease, the exact
genetic and metabolic background of the development of these diseases is still
not known in detail. The Cohort study of Diabetes and Atherosclerosis (CODAM,
initiated in 1999) is a prospective cohort study in the Netherlands aiming at
the investigation of the effects of glucose metabolism and lipids, lifestyle
and genetics on the development of cardiovascular disease and cardiovascular
complications.
Study objective
In the current study we will re-examine the participants of the CODAM study in
a second follow-up evaluation (12 yrs after baseline) in order to obtain
further longitudinal information on the natural development of type 2 diabetes
and cardiovascular disease in elderly subjects. This investigation will enrich
and strengthen the scientific data obtained in the CODAM baseline (CODAM1; MEC
99-112) and first follow-up (CODAM2; MEC 05-170; 7 yrs after baseline)
evaluations. Multiple follow-up measurements (i.e. at multiple time-points; as
opposed to only one) will substantially improve our power to identify and
validate the relevant novel risk markers and risk factors for these common and
highly relevant disorders.
Study design
Observational, longitudinal, prospective cohort study
Study burden and risks
Participation involves three site visits, during which a detailed health
check-up is conducted. The detailed assessmentof 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 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.
Universitetissingel 50
Maastricht 6229 ER
NL
Universitetissingel 50
Maastricht 6229 ER
NL
Listed location countries
Age
Inclusion criteria
Partricipant in baseline measurement of the CODAM study (MEC99-112)
Exclusion criteria
None, except for limitations that interfere with any of the procedured 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 |
|---|---|
| CCMO | NL37680.068.12 |