Investigation of laboratory and clinical parameters in the background of thrombosis in celiac disease and inflammatory bowel diseases
| ISRCTN | ISRCTN49677481 |
|---|---|
| DOI | https://doi.org/10.1186/ISRCTN49677481 |
| Secondary identifying numbers | N/A |
- Submission date
- 05/03/2018
- Registration date
- 29/06/2018
- Last edited
- 11/07/2023
- Recruitment status
- No longer recruiting
- Overall study status
- Completed
- Condition category
- Digestive System
Plain English Summary
Background and study aims
Celiac disease (CD) or gluten-sensitive enteropathy is a immune system disorder affecting 1% of the Western population, while inflammatory bowel disease (IBD) is less common. Hypercoagulability (an increased tendency for the blood to clot) is associated with several immune-mediated disorders, including CD and IBD. The aim of this study is to assess the properties of blood and blood flow in CD and IBD patients compasred with people without these diseases to understand whether having CD or IBD means people are more likely to have problems involving blood clots..
Who can participate?
We will include CD patients, IBD patients, and non-CD, non-IBD volunteers. Adults (≥18 years) will be included irrespective of gender.
What does the study involve?
Participants will give blood and urine samples, fill in questionnaires and be interviewed by researchers.
What are the possible benefits and risks of participating?
This is an observational study, which means there is no treatment given. The study involves assessing the normal situation. Only those patients where blood tests have already been ordered for medical reasons (e.g., at a follow-up visit or for diagnostic purposes) will be included. Patients may benefit from the results of detailed laboratory investigations and dietary assessment. Due to the observational design of the study, there will be no side effects.
When is the study starting and how long is it expected to run for?
March 2018 to May 2020 (updated 13/06/2019, previously: December 2019)
Who is funding the study?
No financial compensation will be given to the participants and there is no extra cost to them. Since no additional treatment is necessary for the study, the general healthcare costs are covered by the National Healthcare System (University of Pécs – Medical School). Center costs and the cost of the study are funded by the following grants: University of Pécs Medical School, Momentum Grant of the Hungarian Academy of Sciences (LP2014-10/2014), Highly Cited Publication Grant (KH 125678) of the National Research Development and Innovation Office (GINOP 2.3.2-15-2016-00048 Stay Alive) and (EFOP 3.6.2-16-2017-00006 Live Longer), and Translational Medicine Foundation. In addition, this project is supported by the ÚNKP-17-3-II New National Excellence Program of the Ministry of Human Capacities.
Who is the main contact?
Peter Hegyi, hegyi.peter@med.u-szeged.hu
Contact information
Scientific
12 Szigeti Street
Pécs
7624
Hungary
| Phone | 0036703751031 |
|---|---|
| hegyi.peter@med.u-szeged.hu |
Study information
| Study design | Prospective controlled cross-sectional trial |
|---|---|
| Primary study design | Observational |
| Secondary study design | Cross sectional study |
| Study setting(s) | Hospital |
| Study type | Other |
| Participant information sheet | Patient information material will be available from: www.tm-centre.org |
| Scientific title | Hemorheologic parameters in celiac disease and inflammatory bowel diseases: a prospective controlled study |
| Study acronym | HERMES |
| Study hypothesis | Hemorheologic alterations may be responsible for the increased risk of thrombosis in celiac (CD) and inflammatory bowel disease (IBD) patients. |
| Ethics approval(s) | University of Pécs Regional and Local Research Ethics Committee, 08/12/2017, 6917 |
| Condition | Celiac disease, inflammatory bowel disease (Crohn’s disease and ulcerative colitis) |
| Intervention | We will include 50 CD patients, 50 IBD patients, and 50 non-celiac, non-IBD control subjects (age- and sex-matched inclusion after recruiting CD and IBD patients) in the first phase of the study. Then, an interim analysis will be performed to assess power and establish the need for further recruitment. Questionnaires, interviews, urine collection, and blood sampling will be carried out on the day of recruitment. 1. Questionnaires will be applied, as follows: a thrombophilia questionnaire (assessing risk factors and history of venous and arterial thrombotic events) to all participants, Gastrointestinal Symptoms Rating Scale (GSRS) and self-reported dietary adherence (on a scale between 1 and 10 and following the work of Silvester published in 2016 in J Hum Nutr Diet) to CD patients, and Mayo score/Crohn's Disease Activity Index to IBD patients. 2. Venous blood samples will be collected to measure routine laboratory parameters (bilirubin, urea, creatinine, cholesterol (total, high-density and low-density lipoproteins), triglyceride, aspartate- aspartate aminotransferase, alanine aminotransferase, alkaline phosphatase, gamma glutamyl transferase, total protein, albumin, immunoglobulins, C-reactive protein, vitamin B12, prothrombin, thrombin time, activated partial thromboplastin time, fibrinogen, blood counts, erythrocyte sedimentation, antithrombin activity, protein C activity, protein S activity, antiphospholipid antibodies (lupus anticoagulans, cardiolipin IgG/A/M, B2-glycoprotein-I IgG/A/M, prothrombin IgG/A/M), celiac specific antibodies (tissue transglutaminase IgA/G, gliadin IgA, endomysium IgA)) and hemorheologic tests (erythrocyte aggregation and deformability, viscosity of whole blood and plasma). After preparation, remaining samples (whole blood and plasma) will be stored in the Biobank of Institute for Translational Medicine, University of Pécs at -80°C. 3. Mid-stream urine will be collected and stored at -80°C until processing. After preparation (centrifugation, solid-phase extraction, lyophilisation), gluten immunogenic peptides will be detected by commercial ELISA (Biomedal, Spain). |
| Intervention type | Not Specified |
| Primary outcome measure | Hemorheologic test results including erythrocyte deformability and aggregation and viscosity of whole blood and plasma The measurement of laboratory parameters will be done on the day of recruitment. |
| Secondary outcome measures | Risk of arterial and venous thrombosis (determined by clinical and laboratory measures on the day of recruitment) |
| Overall study start date | 01/03/2018 |
| Overall study end date | 01/10/2020 |
Eligibility
| Participant type(s) | Mixed |
|---|---|
| Age group | Adult |
| Lower age limit | 18 Years |
| Sex | Both |
| Target number of participants | 50 CD patients, 50 IBD patients, and 50 non-celiac, non-IBD control subjects (age- and sex-matched inclusion after recruiting CD and IBD patients), then an interim analysis will be performed. Further recruitment will be arranged by the power of comparisons of hemorheologic test results of CD and control and IBD vs. control patients. |
| Total final enrolment | 212 |
| Participant inclusion criteria | CD patients 1. Newly diagnosed or followed-up patients (with or without adhering to a gluten-free diet (GFD) 2. Aged ≥18 years 3. Diagnosis should meet the current guidelines (ESPHGAN, American College of Gastroenterology) IBD patients 1. Newly diagnosed and followed-up patients 2. Aged ≥18 years 3. Diagnosis should meet the current guidelines (ECCO) Non-CD, non-IBD controls 1. Aged ≥18 years 2. Celiac disease excluded (lack of symptoms and negative celiac-specific serology) 3. IBD excluded (lack of clinical, biochemical, endoscopic or radiologic signs of the disease) |
| Participant exclusion criteria | 1. Estimated glomerular filtration rate calculated with CKD-EPI formula <60 ml/min/1.73 m2 (CKD Stage 3 or more severe kidney failure) 2. Liver cirrhosis (Child-Pugh class B/C) 3. Heart failure (NYHA class III/IV) 4. Malignant diseases (except for cured cases) 5. Acute diseases within 2 weeks of sampling 6. Patients unable to understand the essentials of the informed consent |
| Recruitment start date | 01/05/2018 |
| Recruitment end date | 01/07/2019 |
Locations
Countries of recruitment
- Hungary
Study participating centre
Pécs
7624
Hungary
Sponsor information
Research organisation
12 Szigeti Street
Pécs
7624
Hungary
| Phone | 0072533100 |
|---|---|
| hegyi.peter@med.u-szeged.hu | |
| Website | https://tm-centre.org |
"ROR" |
https://ror.org/037b5pv06 |
Funders
Funder type
Government
No information available
Results and Publications
| Intention to publish date | 01/04/2021 |
|---|---|
| Individual participant data (IPD) Intention to share | Yes |
| IPD sharing plan summary | Available on request |
| Publication and dissemination plan | Planned publication in a high-impact peer reviewed journal |
| IPD sharing plan | The datasets generated during and/or analysed during the current study are available from the corresponding author on reasonable request |
Study outputs
| Output type | Details | Date created | Date added | Peer reviewed? | Patient-facing? |
|---|---|---|---|---|---|
| Protocol article | protocol | 23/03/2019 | 09/04/2020 | Yes | No |
| Results article | 01/11/2020 | 23/11/2021 | Yes | No | |
| Abstract results | Abstract P2052; UEG - United European Gastroenterology Week 2019 Poster Presentations | 01/10/2019 | 11/07/2023 | No | No |
Editorial Notes
11/07/2023: Publication reference added.
23/11/2021: Publication reference added.
04/05/2020: The following changes have been made:
1. The recruitment end date has been changed from 31/05/2020 to 01/07/2019.
2. The total final enrolment has been added.
09/04/2020: Publication reference added.
08/01/2020: Internal review.
13/06/2019: The following changes were made to the trial record:
1. The recruitment end date was changed from 31/05/2019 to 31/05/2020.
2. The overall end date was changed from 31/12/2019 to 01/10/2020.
3. The intention to publish date was changed from 31/12/2020 to 01/04/2021.
4. The plain English summary was updated to reflect these changes.
