Contact information
Type
Scientific
Primary contact
Dr Erica Rutten
ORCID ID
Contact details
Center of expertise for chronic organ failure (Ciro) Horn
P.O. Box 4080
Horn
6080 AB
Netherlands
ericarutten@proteion.nl
Additional identifiers
EudraCT number
ClinicalTrials.gov number
Protocol/serial number
N/A
Study information
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
Acronym
IPEX
Study hypothesis
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
Not provided at time of registration
Study design
Observational case-control study
Primary study design
Observational
Secondary study design
Case-control study
Trial setting
Hospitals
Trial type
Diagnostic
Patient information sheet
Not available in web format, please use the contact details below to request a patient information sheet
Condition
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
Phase
Not Applicable
Drug names
Primary outcome measures
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 trial start date
01/10/2009
Overall trial end date
01/10/2010
Reason abandoned
Eligibility
Participant 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
Participant type
Patient
Age group
Adult
Gender
Both
Target number of participants
70 COPD subjects and 35 control subjects
Participant 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
Recruitment start date
01/10/2009
Recruitment end date
01/10/2010
Locations
Countries of recruitment
Netherlands
Trial participating centre
Center of expertise for chronic organ failure (Ciro) Horn
Horn
6080 AB
Netherlands
Sponsor information
Organisation
Top Institute Pharma (TIPharma) (Netherlands)
Sponsor details
Wassenaarseweg 72
Leiden
2333 AL
Netherlands
Sponsor type
Industry
Website
Funders
Funder type
Industry
Funder name
Top Institute Pharma (TIPharma) (Netherlands)
Alternative name(s)
TI Pharma
Funding Body Type
private sector organisation
Funding Body Subtype
other non-profit
Location
Netherlands
Results and Publications
Publication and dissemination plan
Not provided at time of registration
Intention to publish date
Participant level data
Not provided at time of registration
Results - basic reporting
Publication summary