Clinical trial for Coeliac Disease
Official title Cardiovascular Risk Factors in Coeliac Disease: a Series of Studies
ClinicalTrials.gov ID: NCT05530070
What this study is testing
- What it's testing
- The study looks at heart‑risk factors like metabolism and body composition in celiac patients and sees how they change with treatment.
- Who it's for
- People who have been newly diagnosed with celiac disease or are already receiving treatment.
- What's involved
- Participants will follow a dietary plan and have their body composition and metabolic health measured through tests and visits.
Which group you join is decided by chance.
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 18 and older
You may be able to join if
- Age should be over 18 years.
- Blood collection must be indicated with medical conditions.
- The diagnosis of CD should be set up according to the current guidelines (based on serology and histology in adults or as per the European Society...
- The newly diagnosed CD patients should be on a gluten-containing diet.
- Patients following a GFD for at least 1 year should exhibit good dietary adherence.
You likely can't join if
- Estimated glomerular filtration rate calculated with the Chronic Kidney Disease Epidemiology Collaboration (CKD-EPI) formula is \<60mL/min/1.73m2...
- Liver cirrhosis in Child-Pugh class B-C.
- Heart failure (New York Heart Association (NYHA) III-IV).
- Active malignant diseases.
- Any acute diseases or acute deterioration of underlying chronic conditions.
- Diseases that may be associated with clinically relevant malabsorption.
See the full eligibility criteria
- Age should be over 18 years.
- Blood collection must be indicated with medical conditions.
- The diagnosis of CD should be set up according to the current guidelines (based on serology and histology in adults or as per the European Society for Paediatric Gastroenterology Hepatology and Nutrition (ESPGHAN)...
- The newly diagnosed CD patients should be on a gluten-containing diet.
- Patients following a GFD for at least 1 year should exhibit good dietary adherence.
- In the assigned by chance controlled trial (RCT), strict dietary adherence will be established based on CD-specific serology (normal level of antibodies), urine gluten immunogenic peptides (negative urine test), and...
- Control people should be free from CD according to the recent guidelines and should be on a gluten-containing diet.
- Estimated glomerular filtration rate calculated with the Chronic Kidney Disease Epidemiology Collaboration (CKD-EPI) formula is \<60mL/min/1.73m2 (CKD3 or more severe kidney failure).
- Liver cirrhosis in Child-Pugh class B-C.
- Heart failure (New York Heart Association (NYHA) III-IV).
- Active malignant diseases.
- Any acute diseases or acute deterioration of underlying chronic conditions.
- Diseases that may be associated with clinically relevant malabsorption.
- Refractory CD.
- Pregnancy, lactation.
- Patients unable to understand the essentials of the informed consent.
- Lack of consent or withdrawal of consent.
The study team makes the final eligibility decision.
Where it is enrolling
- Pécs, Baranya, Hungary
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part, but confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling all sexes, 18 years and older. The study team makes the final eligibility decision.
Where is this trial taking place?
This study is enrolling now at Pécs, Baranya, Hungary. Enter your location above to see the nearest enrolling site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool that is independent of the study sponsor. Details come from ClinicalTrials.gov. The study team decides eligibility, and your own doctor gives medical advice.