Aim of the study is to determine the microvascular function in type 1 diabetes patients with concomitant celiac disease
ID
Source
Brief title
Condition
- Vascular disorders NEC
Synonym
Research involving
Sponsors and support
Intervention
Outcome measures
Primary outcome
3 primary study parameters which determine the microvascular function:
- Capillary recruitment after post-occlusive hyperaemia
- Acetylcholine mediated vasodilatation
- Accumulation of Advanced Glycation End product in the skin
Secondary outcome
Not applicable
Background summary
Patients with type 1 diabetes are at increased risk of developing celiac
disease. Further, patients with diabetes are at increased risk of developing
diabetic complications such as diabetic retinopathy, nephropathy and
neuropathy. When patients with type 1 diabetes have concomitant celiac disease
and are treated with a gluten free diet this might be of influence on those
diabetic complications. However, little research has been done to identify the
effect of concomitant celiac disease on those microvascular complications. This
data is of importance since this will answer the questions whether: 1) Type 1
diabetes patients should be regularly screened for celiac disease? 2) Whether
the interval of follow-up of those patients with type 1 diabetes and celiac
disease should be more often and more carefull than those withoud celiac
disease?
Study objective
Aim of the study is to determine the microvascular function in type 1 diabetes
patients with concomitant celiac disease
Study design
Case controll en prospective design of the study.
15 patients with type 1 diabetes and concomitant celiac disease (who are
treated with a gluten free diet) will be invited for our study and to attend to
the VU University Medical Center. Microvascular function will be assessed by
two non-invasive measurements of the skin. By using skin autofluorescence the
accumulation of Advanced Glycation End products will be measured, this is
another non-invasive measurement.
These study patients will be compared with a control group consisting of type 1
diabetes without celiac disease. These patients are carefully matched by
gender, age, duration of type 1 diabetes and glycemic control (HbA1c levels).
15 patienten met diabetes en coeliakie (behandeld met een glutenvrij dieet)
worden uitgenodigd om naar de VU te komen. Alhier wordt middels 2 non-invasieve
testen de microvasculaire functie bepaald en middels een test wordt de
concentratie van Advanced Glycation End (AGE) products in de huid bepaald. Deze
patienten worden vergeleken met een controle groep van patienten met diabetes
zonder coeliakie en worden zorgvuldig gematcht op geslacht, leeftijd, duur van
de diabetes en glycemische controle.
Study burden and risks
The measurements of microvascular function and of AGE accumulation is not-till
moderately of risk for our participating patients. This is due to the fact
that those measurements occur on the surface of the skin. All 3 measurements
are not invasive and carry no additional risks.
Blood withdrawal by a venapunction might be painfull for the participating
patient as this is an invasive procedure. Furthermore, after blood withdrawal
the occurence of a hematoma is possible.
According to our opinion the questionary is not an extra burden to the patient.
The benefit for the patient is related to the group analysis. According to the
results change in treatment and follow-up for type 1 diabetes patients with
concomitant celiac disease might occur in the future.
De Boelelaan 1117
Amsterdam 1081 HV
NL
De Boelelaan 1117
Amsterdam 1081 HV
NL
Listed location countries
Age
Inclusion criteria
- Men and women older than 18 years of age
- Patients diagnosed with type 1 diabetes
- Patients with concomitant celiac disease for at least one year
- Informed consent
- Duration of T1DM between 9 and 14 years
Exclusion criteria
- A psychiatric, addictive or any disorder that compromises the patient to understand the study content and to give written informed consent for participation in this study.
- A history of Raynaud's disease, scleroderma or concurrent infection
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 | NL40438.029.12 |