Compromised HealthNCT01656915
Ex Vivo LPS Stimulation in Healthy and Compromised Subjects
An observational study of Compromised Health and Healthy, run by TNO at 1 site in Netherlands.
Trial summary
Ex vivo LPS stimulation of whole blood will be a good alternative challenge to induce an inflammatory response and examine differences in the inflammatory response between healthy and compromised subjects. Read more about this study
- Who is it for?
- Ages 35 to 45 years, men onlyHealthy volunteers can take part
- Conditions the study is for
- Compromised Health, Healthy
- How many people
- 36 participants
- Where
- 1 siteNetherlands
- Study dates
- Jun 2012to Oct 2012
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 35 to 45 years
- Men only
- Healthy volunteers accepted
- Adult
Study population: In total, 36 male subjects will participate in the study. The study will be conducted in two different subject groups (one healthy and one compromised group), each consisting of 18 subjects.
Who may be able to join
- Healthy as assessed by the health and lifestyle questionnaire, physical examination and results of the pre-study laboratory tests;
- Males aged between 35-45 years;
- Waist circumference: healthy < 94 cm, compromised ≥ 102 cm.
- Body composition (InBody 720): body fat % healthy men < 8-19% %; for compromised men > 25%;
- HbA1c levels for healthy subjects < 5.5 % or fasting glucose > 3.4 or < 5.6 mmol/L; for compromised HbA1c >=6 and< 6.5% or fasting glucose between 6.1-6.9 mmol/L;
- Regular Dutch eating habits as assessed (three main meals, including bread) by health and lifestyle questionnaires.
Who cannot join
- Participation in any clinical trial including blood sampling and/or administration of substances up to 90 days before Day 01 of this study;
- Participation in any non-invasive clinical trial up to 30 days before Day 01 of this study, including no blood sampling and/or oral, intravenous, inhalatory administration of substances;
- Having a history of medical or surgical events that may significantly affect the study outcome, including any psychiatric history, and metabolic or endocrine disease, or any gastro-intestinal disorder or inflammatory diseases or allergy;
- Use of any medication within 14 days before day 01; use of paracetamol within 7 days before day 01;
- Currently smoking or stopped smoking less than 6 months ago;
- Alcohol consumption >= 21 units per week;
Show all 11Show fewer
- Performing more than 5 hour sports activity per week;
- Use of dietary supplements that could affect the inflammatory response (eg fish oil, polyphenols, vitamins);
- Not having a general practitioner;
- Not willing to accept information transfer which concerns participation in the study, or information regarding health, like laboratory results, findings at anamnesis or physical examination and eventual adverse events to and from his general practitioner;
- Not willing to give permission to have the general practitioner to be notified upon participation in this study.
Trial locations and contacts
1 site in 1 country.
About this study
Ex vivo LPS stimulation of whole blood will be a good alternative challenge to induce an inflammatory response and examine differences in the inflammatory response between healthy and compromised subjects.
The purpose of the current study is to examine the inflammatory response in a younger population (35-45 yrs old) to see whether in this population also differences in the ex vivo LPS induced cytokine response exists between healthy and compromised subjects, as is seen in elderly subjects. Overweight subjects showing a state of disturbed blood glucose control will be included as subjects with compromised health and compared to healthy lean subjects with the same age (shifting from healthy towards unhealthy, not diseased).
Hypothesis Ex vivo LPS stimulation of whole blood will induce a measurable inflammatory cytokine response in a healthy population that is different from a response of the compromised population. The investigators will include subjects aged 35-45 years that differ in health characteristics, especially blood HbA1c, fat% and waist circumference.
- Conditions
- Compromised Health, Healthy
- Keywords
- inflammation, response, resilience, cytokines, pre-diabetes
- Medical subject headings
- Inflammation, Glucose Intolerance
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| Healthy men | Healthy male subjects with normal weight | |
| Compromised men | pre-diabetic overweight, male subjects |
What is being measured
The primary outcome is the main question the study is designed to answer.
Cytokines
The levels of interleukines present in healthy and compromised subjects will be determined in a baseline sample.
Measured: baseline, 4h and 24h incubation with ex vivo LPS
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted3 Aug 2012 (estimated)
- Study startJun 2012
- Primary completionAug 2012
- Study completionOct 2012
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Compromised HealthStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Case-control
- Enrolment
- 36 participants (actual)
Sponsor and investigators
- Lead sponsor
- TNO
- Sponsor type
- University, hospital or other
- Collaborators
- Unilever R&D, Netherlands Metabolomic Center (NMC), The Netherlands
- Responsible party
- Principal investigator, W.J. Pasman, TNO
- Investigators
- Pierre Peeters, PhD, Principal investigator, CHDR Leiden
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01656915
- Sponsor's protocol ID
- CHDR1212
- Status last verified
- Jun 2013
- First submitted
- 20 Jun 2012
- Last updated
- 19 Jun 2013
- Results posted
- No
- Data monitoring committee
- Yes
Publications
Wijsman CA, Maier AB, de Craen AJ, van den Biggelaar AH, Westendorp RG. An unopposed proinflammatory response is beneficial for survival in the oldest old. Results of the Leiden 85-plus Study. J Gerontol A Biol Sci Med Sci. 2011 Apr;66(4):393-9. doi: 10.1093/gerona/glq212. Epub 2010 Dec 22.
PubMed 21177757
Study at a glance
From the registry record, last updated by the sponsor on 19 Jun 2013. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Ex Vivo LPS Stimulation in Healthy and Compromised Subjects
- ClinicalTrials.gov ID
- NCT01656915
- Acronym / sponsor ID
- CHDR1212
- Conditions
- Compromised Health, Healthy
- Keywords
- inflammation, response, resilience, cytokines, pre-diabetes
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 36 participants (actual)
- Lead sponsor
- TNOUniversity, hospital or other
- Collaborators
- Unilever R&D, Netherlands Metabolomic Center (NMC), The Netherlands
- Study start
- Jun 2012
- Primary completion
- Aug 2012 (actual)
- Study completion
- Oct 2012 (actual)
- First posted
- 3 Aug 2012 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
Ex vivo LPS stimulation of whole blood will be a good alternative challenge to induce an inflammatory response and examine differences in the inflammatory response between healthy and compromised subjects.
The purpose of the current study is to examine the inflammatory response in a younger population (35-45 yrs old) to see whether in this population also differences in the ex vivo LPS induced cytokine response exists between healthy and compromised subjects, as is seen in elderly subjects. Overweight subjects showing a state of disturbed blood glucose control will be included as subjects with compromised health and compared to healthy lean subjects with the same age (shifting from healthy towards unhealthy, not diseased).
Hypothesis Ex vivo LPS stimulation of whole blood will induce a measurable inflammatory cytokine response in a healthy population that is different from a response of the compromised population. The investigators will include subjects aged 35-45 years that differ in health characteristics, especially blood HbA1c, fat% and waist circumference.
Study design
- Observational model
- Case-control
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Healthy men | – | –Healthy male subjects with normal weight |
| Compromised men | – | –pre-diabetic overweight, male subjects |
Who may qualify
- Ages
- 35 to 45 years
- Sex
- Male only
- Healthy volunteers
- Accepted
- Age groups
- Adult
- Study population
- In total, 36 male subjects will participate in the study. The study will be conducted in two different subject groups (one healthy and one compromised group), each consisting of 18 subjects.
Key inclusion criteria (6 listed)
- Healthy as assessed by the health and lifestyle questionnaire, physical examination and results of the pre-study laboratory tests;
- Males aged between 35-45 years;
- Waist circumference: healthy < 94 cm, compromised ≥ 102 cm.
- Body composition (InBody 720): body fat % healthy men < 8-19% %; for compromised men > 25%;
- HbA1c levels for healthy subjects < 5.5 % or fasting glucose > 3.4 or < 5.6 mmol/L; for compromised HbA1c >=6 and< 6.5% or fasting glucose between 6.1-6.9 mmol/L;
Key exclusion criteria (11 listed)
- Participation in any clinical trial including blood sampling and/or administration of substances up to 90 days before Day 01 of this study;
- Participation in any non-invasive clinical trial up to 30 days before Day 01 of this study, including no blood sampling and/or oral, intravenous, inhalatory administration of substances;
- Having a history of medical or surgical events that may significantly affect the study outcome, including any psychiatric history, and metabolic or endocrine disease, or any gastro-intestinal disorder or inflammatory diseases or allergy;
- Use of any medication within 14 days before day 01; use of paracetamol within 7 days before day 01;
- Currently smoking or stopped smoking less than 6 months ago;
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Cytokines
Time frame: baseline, 4h and 24h incubation with ex vivo LPS
The levels of interleukines present in healthy and compromised subjects will be determined in a baseline sample.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 19 Jun 2013.
- Background: PubMed 21177757Wijsman CA, Maier AB, de Craen AJ, van den Biggelaar AH, Westendorp RG. An unopposed proinflammatory response is beneficial for survival in the oldest old. Results of the Leiden 85-plus Study. J Gerontol A Biol Sci Med Sci. 2011 Apr;66(4):393-9. doi: 10.1093/gerona/glq212. Epub 2010 Dec 22.
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Pierre Peeters, PhD principal investigator
CHDR Leiden
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Compromised Health and Healthy, run by TNO at 1 site in Netherlands.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 6 inclusion and 11 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 19 Jun 2013. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Netherlands. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Cytokines (time frame: baseline, 4h and 24h incubation with ex vivo LPS). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT01656915, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 19 Jun 2013.