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
Source
Brief title
Condition
- Coronary artery disorders
- Diabetic complications
- Nephropathies
Synonym
Research involving
Sponsors and support
Intervention
Outcome measures
Primary outcome
As different research questions will be formulated regarding our main
objective, different endpoints will be investigated such as:
• Blood pressure
• Renal function represented by creatinine clearance (calculated from 24h urine
creatinine excretion and plasma creatinine concentration)
• Occurrence of micro- and macrovascular complications
• Glucose variability determined by continuous glucose monitoring
Secondary outcome
Not applicable
Background summary
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.
Study 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 burden and risks
There are no direct benefits for the patients to be included. Participation in
the study is on a free-will base. Patients will not receive any financial
support orpriority for treatment of other diseases in the clinic during this
study. Patients will be asked to fill in questionnaires concerning their
dietary intake, lifestyles, quality of life and beliefs on medication. 24-hour
urine have to be collected by the patients, as well as a single portion of
morning void urine. During their visit, blood pressure, weight, height, waist
and hip circumference, physical condition, body impedance and peripheral
polyneuropathy will be assessed. Blood samples will be drawn using
venipuncture. Samples of the 24h urine, morning void urine and blood will be
stored in -80°C according to the UMCG biobank regulations. No further invasive
measurements will be executed and therefore risks of participation in this
study are minimal, if present at all.
Zilvermeeuw 1
Almelo 7609PP
NL
Zilvermeeuw 1
Almelo 7609PP
NL
Listed location countries
Age
Inclusion criteria
• Patients with type 2 diabetes mellitus
• Patients aged 18 years or older
Exclusion criteria
• Dependence on renal dialysis
• Severe general diseases or mental disorders making the participation in the
study impossible
• Drug abuse (w/hich will be assessed through anamnesis)
• Not able to give written informed consent
Design
Recruitment
Followed up by the following (possibly more current) registration
No registrations found.
Other (possibly less up-to-date) registrations in this register
In other registers
| Register | ID |
|---|---|
| CCMO | NL57219.044.16 |