Intestinal permeability during exercise (IPEX)

ISRCTN	ISRCTN33686980
DOI	https://doi.org/10.1186/ISRCTN33686980
Protocol serial number	N/A
Sponsor	Top Institute Pharma (TIPharma) (Netherlands)
Funder	Top Institute Pharma (TIPharma) (Netherlands)

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

Primary study design	Observational
Study design	Observational case-control study
Secondary study design	Case-control study
Study type	Participant 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(s)	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
Key secondary outcome measure(s)	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
Completion date	01/10/2010

Eligibility

Participant type(s)	Patient
Age group	Adult
Sex	All
Target sample size at registration	105
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

Results and Publications

Individual participant data (IPD) Intention to share	No
IPD sharing plan summary	Not 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
Participant information sheet	Participant information sheet	11/11/2025	11/11/2025	No	Yes