1) Prevalence of celiac disease in a Dutch cohort of adult type 1 diabetes patients. 2) Investigation of the long term complications of type 1 diabetes patients with concomitant celiac disease
ID
Source
Brief title
Condition
- Diabetic complications
- Malabsorption conditions
Synonym
Research involving
Sponsors and support
Intervention
Outcome measures
Primary outcome
The prevalence of celiac disease in a Dutch cohort of type 1 diabetes patients
Secondary outcome
To compare several clinical parameters between two groups ( patients with
celiac disease and type 1 diabetes compared to patients with type 1 diabetes)
Background summary
The prevalence of celiac disease in adult patients with type 1 diabetes is
about 5 %. This is 5 times higher compared to the general population.
Screening for celiac disease in a paediatric population with type 1 diabetes
is mandatory. Screening for celiac disease in a pediatric population is
mandatory because of the known side effects of concomitant celiac disease.
Concomitant celiac disease is associated with growth problems and brittle
glucose regulation.
In adult patients with type 1 diabetes screening for celiac disease remains
questionable. Long term complications of type 1 diabetes are retinopathy,
nefropathy and neuropathy. Long term complications of celiac disease are
osteoporosis and increased risk of developing Enteropathy Associated Lymphoma
(EATL). It is unknown what the effect is of concomitant celiac disease on the
long term complications of type 1 diabetes.
If screening for celiac disease in an adult population of type 1 diabetes is
necessary is unknown: this is largely due to a lack of clinical data of those
patients.
Study objective
1) Prevalence of celiac disease in a Dutch cohort of adult type 1 diabetes
patients.
2) Investigation of the long term complications of type 1 diabetes patients
with concomitant celiac disease
Study design
First step:
1) Screening for celiac disease by the use of antibodies against Tissue
Transglutaminase in type 1 diabetes patients.
2) In case of positivity: secondary serological screening for anti endomysium
3) In case of positivity for TGA and/ or Endomysium a gastrocopy will be
performed. A gastroscopy with biopsy is the gold standard for celiac disease
diagnosis and is a diagnostic procedure which is necessary in case of positive
TGA/EMA.
The second step:
Adult patients with type 1 diabetes and concomitant celiac disease will be
clinically investigated.
- microvascular complications:
- retinopathy ( data of the opthalmologist)
- nefropathy ( data of the annual control by the internal medicine)
- neuropathy ( data of the podotherapist)
Bone mineral density:
- DEXA scan ( additional)
- blood investigations: calcium, vitamin D, PTH, phosphate
Adult patients with the dubble diagnosis will be clinically compared with type
1 diabetes patients alone in a nested case control analysis.
Study burden and risks
Serological screening for TGA carries no additional risk. Vena punction has to
be performed in case of annual follow up by the doctor of internal medicine.
In case of positivity for TGA and/or EMA a gastroscopy will be performed. The
specificity of these antibodies is nearly 100 % although a biopsy remains the
golden standard.
DEXA scan: no additional risk
Additional blood collection: no additional risk
De Boelelaan 1117
1081 HV Amsterdam
NL
De Boelelaan 1117
1081 HV Amsterdam
NL
Listed location countries
Age
Inclusion criteria
- Men and women > 18 years of age
- Patients diagnosed with T1DM based on an absolute requirement of insulin or the presence of GAD/ insulin, IcA antibodies in serum.
- Informed consent
Exclusion criteria
- Age under 18 years
- The presence of type 2 diabetes
- A psychiatric, addictive or any disorder that compromises the subjects ability to understand the study content and to give written informed consent for participation in the study.
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 | NL36537.094.11 |