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DIALECT, "DIAbetes and LifEstyle Cohort Twente"


- candidate number24265
- NTR NumberNTR5855
- ISRCTNISRCTN no longer applicable
- Date ISRCTN created
- date ISRCTN requested
- Date Registered NTR19-apr-2016
- Secondary IDsNL57219.044.16 METC-Twente
- Public TitleDIALECT, "DIAbetes and LifEstyle Cohort Twente"
- Scientific TitleDIALECT, "DIAbetes and LifEstyle Cohort Twente"
- ACRONYMDIALECT
- hypothesisThe primary objective of this study is to investigate the effect of lifestyle and dietary habits on outcomes in patients with type 2 diabetes mellitus.
- Healt Condition(s) or Problem(s) studiedDiabetes Mellitus Type 2 (DM type II)
- Inclusion criteria 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
- Exclusion criteria 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)
- mec approval receivedyes
- multicenter trialno
- randomisedno
- groupCrossover
- TypeSingle arm
- Studytypeobservational
- planned startdate 31-aug-2009
- planned closingdate31-dec-2024
- Target number of participants850
- InterventionsNONE
- Primary outcome 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
- Secondary outcome- blood pressure
- kidney function
- albuninurie
- Timepoints- 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
- Trial web site
- statusopen: patient inclusion
- CONTACT FOR PUBLIC QUERIESDr. G.D. Laverman
- CONTACT for SCIENTIFIC QUERIESDr. G.D. Laverman
- Sponsor/Initiator ZGT Hospital
- Funding
(Source(s) of Monetary or Material Support)
ZGT Hospital
- Publications
- Brief summaryType 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
- Main changes (audit trail)
- RECORD19-apr-2016 - 1-jul-2016


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