ISRCTN ISRCTN33686980
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

Center of expertise for chronic organ failure (Ciro) Horn
P.O. Box 4080
Horn
6080 AB
Netherlands

Email ericarutten@proteion.nl

Study information

Study designObservational case-control study
Primary study designObservational
Secondary study designCase-control study
Study setting(s)Hospital
Study typeDiagnostic
Participant information sheet Not available in web format, please use the contact details below to request a patient information sheet
Scientific titleThe 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 acronymIPEX
Study objectivesIntestinal 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) studiedChronic obstructive pulmonary disease (COPD)
InterventionNo 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 typeOther
Primary outcome measureMarkers 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 measures1. 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 date01/10/2009
Completion date01/10/2010

Eligibility

Participant type(s)Patient
Age groupAdult
SexBoth
Target number of participants70 COPD subjects and 35 control subjects
Total final enrolment32
Key inclusion criteria1. 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 criteria1. 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 enrolment01/10/2009
Date of final enrolment01/10/2010

Locations

Countries of recruitment

  • Netherlands

Study participating centre

Center of expertise for chronic organ failure (Ciro) Horn
Horn
6080 AB
Netherlands

Sponsor information

Top Institute Pharma (TIPharma) (Netherlands)
Industry

Wassenaarseweg 72
Leiden
2333 AL
Netherlands

Website http://www.tipharma.com/pro1/general/home.asp
ROR logo "ROR" https://ror.org/01qmxzb47

Funders

Funder type

Industry

Top Institute Pharma (TIPharma) (Netherlands)
Private sector organisation / Other non-profit organizations
Alternative name(s)
TI Pharma
Location
Netherlands

Results and Publications

Intention to publish date
Individual participant data (IPD) Intention to shareNo
IPD sharing plan summaryNot provided at time of registration
Publication and dissemination planNot provided at time of registration
IPD sharing plan

Study outputs

Output type Details Date created Date added Peer reviewed? Patient-facing?
Results article results 01/02/2014 23/10/2020 Yes No