The primary objective of this study is to investigate the effect of lifestyle and dietary habits on outcomes in patients with type 2 diabetes mellitus.
ID
Bron
Verkorte titel
Aandoening
Type 2 Diabetes Mellitus
Ondersteuning
Internal medicine/nephrology
ZGT Hospital
Internal medicine/nephrology
ZGT Hospital
Onderzoeksproduct en/of interventie
Uitkomstmaten
Primaire uitkomstmaten
• All-cause mortality<br>
• Macrovascular disease:<br>
o coronary disease: myocardial infarction, silent myocardial infarction, hospital admission for unstable angina pectoris or heart failure, coronary artery bypass graft, percutaneous coronary intervention<br>
o other: transient ischemic attack, cerebrovascular accident, diagnosis of peripheral vascular disease, peripheral bypass, percutaneous transluminal angioplasty, foot ulcers, amputation<br>
• Microvascular disease: diagnosis of diabetic retinopathy, diabetic neuropathy, nephropathy<br>
• Renal complications: nephropathy*, doubling of serum creatinine, start of renal replacement therapy
Achtergrond van het onderzoek
Type 2 diabetes mellitus (T2DM) is a highly prevalent disease, causing significant morbidity and mortality worldwide. Poor regulation of serum glucose can lead to debilitating micro- and macrovascular complications such as nephropathy, cardiovascular disease and amputations. Therefore preventing complications is an important treatment goal in T2DM. While numerous research is done on the effect of drug interventions, little is known about the effect of lifestyle and dietary habits. In this research we will focus on the effects of lifestyle and dietary habits on outcomes in T2DM.
Objective:
The primary objective of this study is to investigate the effect of lifestyle and dietary habits on outcomes in patients with type 2 diabetes mellitus.
Study design:
The study is designed as an observational epidemiological study. Cross-sectional and prospective analyses will be performed in a cohort with patients with diabetes.
Study population: The study population will consist of adult male and female patients with type 2 diabetes.
Intervention (if applicable):
Not applicable
Main study parameters/endpoints:
As dDifferent research questions will be formulated regarding our main objective.
Endpoints are, different endpoints will be investigated such as:
• All-cause mortality
• Macrovascular disease:
o coronary disease: myocardial infarction, silent myocardial infarction, hospital admission for unstable angina pectoris or heart failure, coronary artery bypass graft, percutaneous coronary intervention
o other: transient ischemic attack, cerebrovascular accident, diagnosis of peripheral vascular disease, peripheral bypass, percutaneous transluminal angioplasty, foot ulcers, amputation
• Microvascular disease: diagnosis of diabetic retinopathy, diabetic neuropathy, nephropathy
• Renal complications: nephropathy*, doubling of serum creatinine, start of renal replacement therapy
Doel van het onderzoek
The primary objective of this study is to investigate the effect of lifestyle and dietary habits on outcomes in patients with type 2 diabetes mellitus.
Onderzoeksopzet
- Every year in december the outcome measures will be collected from the electronic file from the general practitinor
- one baseline visit at the start of the trial to the clinic
Onderzoeksproduct en/of interventie
NONE
Publiek
G.D. Laverman
Zilvermeeuw 1
Almelo 7600SZ
The Netherlands
Tel: 088-7083079
G.Laverman@zgt.nl
Wetenschappelijk
G.D. Laverman
Zilvermeeuw 1
Almelo 7600SZ
The Netherlands
Tel: 088-7083079
G.Laverman@zgt.nl
Belangrijkste voorwaarden om deel te mogen nemen (Inclusiecriteria)
• Male and female patients with type 2 diabetes
• Patients aged 18 years or older
• Follow-up taking place in the outpatient clinic internal medicine in the ZGT Hospital
• Written informed consent
Belangrijkste redenen om niet deel te kunnen nemen (Exclusiecriteria)
• Dependence on renal dialysis
• Severe general diseases or mental disorders making the participation in the study
impossible
• Drug abuse (which will be assessed through anamnesis)
Opzet
Deelname
Opgevolgd door onderstaande (mogelijk meer actuele) registratie
Andere (mogelijk minder actuele) registraties in dit register
Geen registraties gevonden.
In overige registers
Register | ID |
---|---|
NTR-new | NL5702 |
NTR-old | NTR5855 |
CCMO | NL57219.044.16 |
OMON | NL-OMON53048 |