Intestinal permeability during exercise (IPEX)
ISRCTN | ISRCTN33686980 |
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DOI | https://doi.org/10.1186/ISRCTN33686980 |
Secondary identifying numbers | N/A |
- Submission date
- 30/06/2009
- Registration date
- 04/09/2009
- Last edited
- 23/10/2020
- Recruitment status
- No longer recruiting
- Overall study status
- Completed
- Condition category
- Respiratory
Prospectively registered
Protocol
Statistical analysis plan
Results
Individual participant data
Plain English summary of protocol
Not provided at time of registration
Contact information
Dr Erica Rutten
Scientific
Scientific
Center of expertise for chronic organ failure (Ciro) Horn
P.O. Box 4080
Horn
6080 AB
Netherlands
ericarutten@proteion.nl |
Study information
Study design | Observational case-control study |
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Primary study design | Observational |
Secondary study design | Case-control study |
Study setting(s) | Hospital |
Study type | Diagnostic |
Participant information sheet | Not available in web format, please use the contact details below to request a patient information sheet |
Scientific title | The contribution of the intestinal permeability in the systemic inflammation of patients with chronic obstructive pulmonary disease (COPD) during acute exercise: an observational case-control study |
Study acronym | IPEX |
Study objectives | Intestinal permeability increases during an acute exercise load and plays a role in the systemic inflammation in moderate to severe patients with COPD. |
Ethics approval(s) | Not provided at time of registration |
Health condition(s) or problem(s) studied | Chronic obstructive pulmonary disease (COPD) |
Intervention | No intervention study. The study design includes three test days. During day 1, intestinal permeability at rest will be measured. When a blood samples is taken and urine is collected, subjects will ingest a sugar solution in the fasted state after which urine will be collected for 5 hours. In blood and urine, markers for intestinal permeability will be measured. Day 2 and 3 , the same study procedure will take place after the performance of an acute exercise load. The exercise will include a submaximal ergomtery test at 50% of their Wmax or an activity of daily living (ADL) test. The ADL test exist of a combination of several daily activities: ADL 1: dressing socks, shoes and a coat ADL 2: fold up 8 towels and put them in the laundry basket ADL 3: put 6 cans (all 400 g) in a shopping basket ADL 4: washing 4 plates, 4 cups and 4 saucers and put them in a plate rack ADL 5: for 4 minutes sweeping plastic blocks with a broom The mobile Oxycon will measure the ventilated effort (VO2 and ventilation [VE]) in order to calculate the metabolic response of the activities. |
Intervention type | Other |
Primary outcome measure | Markers for intestinal permeability: In plasma and collected in the post-absorptive state or immediately after exercise: 1. Intestinal fatty acid binding protein (IFABP); 2. Ileal lipid-binding protein (ILBP); 3. Claudine In urine, 5 hours after ingestion of the sugar solution: 4. Urinary concentration of various sugars |
Secondary outcome measures | 1. Markers of systemic inflammation in plasma collected in the post-absorptive state 2. Markers of respiratory permeability (surfactant D) in plasma collected in the post-absorptive state |
Overall study start date | 01/10/2009 |
Completion date | 01/10/2010 |
Eligibility
Participant type(s) | Patient |
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Age group | Adult |
Sex | Both |
Target number of participants | 70 COPD subjects and 35 control subjects |
Total final enrolment | 32 |
Key inclusion criteria | 1. Diagnosis of COPD Global Initiative for chronic Obstructive Lung Disease (GOLD) stage II or III according to the American Thoracic Society (ATS) GOLD guidelines (forced expiratory volume in one second [FEV1] between 30% and 80% predicted and FEV1/forced vital capacity [FVC] less than 70%, and less than 10% predicted improvement in FEV1 after B2-agonist inhalation) 2. Both male and female, age-range from 40 to 75 years 3. No respiratory tract infection or exacerbation of the disease for at least 4 weeks before the study 4. Capable to provide informed consent 5. Presence of other non-gastro-intestinal related and non-renal chronic diseases are allowed in case the clinical status is stable for at least 4 weeks before the study |
Key exclusion criteria | 1. External oxygen supplementation at rest 2. Investigator's uncertainty about the willingness or ability of the patient to comply with the protocol requirements 3. Participation in any other studies involving investigational or marketed products concomitantly or within two weeks prior to entry into the study 4. Any kind of gastro-intestinal complaints or gastro-intestinal disease 5. The presence of cardiovascular disease, assessed by analyses of plasma pro-brain natriuretic peptide (pro-BNP) levels 6. Use of non-steroidal anti-inflammatory drugs (NSAIDs) (ibuprofen, acetylsalicic acid, naproxen, meloxicam, diclofenac) or antibiotics or oral corticosteroids at least 4 weeks before the study |
Date of first enrolment | 01/10/2009 |
Date of final enrolment | 01/10/2010 |
Locations
Countries of recruitment
- Netherlands
Study participating centre
Center of expertise for chronic organ failure (Ciro) Horn
Horn
6080 AB
Netherlands
6080 AB
Netherlands
Sponsor information
Top Institute Pharma (TIPharma) (Netherlands)
Industry
Industry
Wassenaarseweg 72
Leiden
2333 AL
Netherlands
Website | http://www.tipharma.com/pro1/general/home.asp |
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https://ror.org/01qmxzb47 |
Funders
Funder type
Industry
Top Institute Pharma (TIPharma) (Netherlands)
Private sector organisation / Other non-profit organizations
Private sector organisation / Other non-profit organizations
- Alternative name(s)
- TI Pharma
- Location
- Netherlands
Results and Publications
Intention to publish date | |
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Individual participant data (IPD) Intention to share | No |
IPD sharing plan summary | Not provided at time of registration |
Publication and dissemination plan | Not provided at time of registration |
IPD sharing plan |
Study outputs
Output type | Details | Date created | Date added | Peer reviewed? | Patient-facing? |
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Results article | results | 01/02/2014 | 23/10/2020 | Yes | No |