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A prospective cohort study in the development of type 2 diabetes and cardiovascular disease: The CODAM study

A prospective cohort study in the development of type 2 diabetes and cardiovascular disease: The CODAM study - The CODAM (Cohort on Diabetes and Atherosclerosis Maastricht) study

Status
Active, not recruiting
Phases
Unknown
Study type
Observational
Source
NL-OMON
Registry ID
NL-OMON37934
Enrollment
500
Registered
2012-11-19
Start date
2013-01-01
Completion date
Unknown
Last updated
2024-04-29

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

diabetes and cardiovascular disease

Interventions

None listed

Sponsors

Universiteit Maastricht
Lead Sponsor

Eligibility

Age
18 Years to 99 Years

Inclusion criteria

Inclusion criteria: Partricipant in baseline measurement of the CODAM study (MEC99-112)

Exclusion criteria

Exclusion criteria: None, except for limitations that interfere with any of the procedured to obtain informed consent according to the Helsinki declaration

Design outcomes

Primary

MeasureTime frame
(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

MeasureTime frame
(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

Countries

Netherlands

Outcome results

None listed

Source: NL-OMON (via WHO ICTRP)