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Alpha-1-Antitrypsin Deficiency in a Diverticular Disease Population


- candidate number26868
- NTR NumberNTR6251
- ISRCTNISRCTN no longer applicable
- Date ISRCTN created
- date ISRCTN requested
- Date Registered NTR11-mrt-2017
- Secondary IDsNL 55016.094.15 
- Public TitleAlpha-1-Antitrypsin Deficiency in a Diverticular Disease Population
- Scientific TitleAlpha-1-Antitrypsin Deficiency in a Diverticular Disease Population
- ACRONYMALADDIN study
- hypothesisThis study aims to investigate whether A1AT pathology contributes to the development of DD. We will determine the prevalence of A1AT-pathology by phenotyping patients with diverticulosis and compare this to a population without diverticulosis. Better understanding of the association between A1AT-pathology and DD could possibly contribute to changes in the treatment of DD.
- Healt Condition(s) or Problem(s) studiedDiverticulitis, Alpha-1-Antitrypsin Deficiency
- Inclusion criteriaResearch group: the subject has to
- Have acute abdominal pain existing more than two hours’ and less than five days,
- Has a CT-abdomen that shows diverticular disease,
- Age above sixty,
- Be mentally competent, and
- Informed consent.

Control group: the subject has to
- Have acute abdominal pain existing more than two hours’ and less than five days,
- Has a CT-abdomen that shows no diverticular disease,
- Age above sixty,
- Be mentally competent, and
- Informed consent.
- Exclusion criteriaA potential subject who meets any of the following criteria will be excluded from participation in this study:

- Does not meet the inclusion criteria
- Is mentally incompetent
- mec approval receivedyes
- multicenter trialyes
- randomisedno
- groupParallel
- Type2 or more arms, non-randomized
- Studytypeobservational
- planned startdate 1-apr-2017
- planned closingdate1-jan-2019
- Target number of participants304
- InterventionsVenapunction
- Primary outcomeThe main exposure factor is of alpha-1-antitrypsin pathology
- Secondary outcomeSecondary exposure factors are:
- Concentration of alpha-1-antitrypsin
- Inflammation parameters
- Risk factors for developing diverticulosis such as
• Genetic factors
o Family history
• Environmental factors:
o Low-fiber diet
o Obesity
o Decreased physical activity
o Use of corticosteroids
o Use of NSAIDs
o Alcohol
o Caffeine intake
o Cigarette smoking
o Polycystic kidney disease
• Epidemiological factors
o Age
o Geography
o Life style
o Ethnicity
- Timepoints-
- Trial web sitewww.aladdinstudy.com
- statusplanned
- CONTACT FOR PUBLIC QUERIES
- CONTACT for SCIENTIFIC QUERIES
- Sponsor/Initiator Noordwest Ziekenhuisgroep, Tergooiziekenhuizen
- Funding
(Source(s) of Monetary or Material Support)
None
- Publications
- Brief summary
- Main changes (audit trail)
- RECORD11-mrt-2017 - 29-apr-2017


  • Indien u gegevens wilt toevoegen of veranderen, kunt u een mail sturen naar nederlands@trialregister.nl