- ICH GCP
- US Clinical Trials Registry
- Klinisk forsøg NCT01656915
Ex Vivo LPS Stimulation in Healthy and Compromised Subjects
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.
Studieoversigt
Status
Betingelser
Undersøgelsestype
Tilmelding (Faktiske)
Kontakter og lokationer
Studiesteder
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Zuid-Holland
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Leiden, Zuid-Holland, Holland, 2333 CH
- CHDR
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Deltagelseskriterier
Berettigelseskriterier
Aldre berettiget til at studere
Tager imod sunde frivillige
Køn, der er berettiget til at studere
Prøveudtagningsmetode
Studiebefolkning
Beskrivelse
Inclusion Criteria:
- 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.
Exclusion Criteria:
- 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;
- 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.
Studieplan
Hvordan er undersøgelsen tilrettelagt?
Design detaljer
Kohorter og interventioner
Gruppe / kohorte |
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Healthy men
Healthy male subjects with normal weight
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Compromised men
pre-diabetic overweight, male subjects
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Hvad måler undersøgelsen?
Primære resultatmål
Resultatmål |
Foranstaltningsbeskrivelse |
Tidsramme |
---|---|---|
Cytokines
Tidsramme: 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.
|
baseline, 4h and 24h incubation with ex vivo LPS
|
Samarbejdspartnere og efterforskere
Sponsor
Efterforskere
- Ledende efterforsker: Pierre Peeters, PhD, CHDR Leiden
Publikationer og nyttige links
Datoer for undersøgelser
Studer store datoer
Studiestart
Primær færdiggørelse (Faktiske)
Studieafslutning (Faktiske)
Datoer for studieregistrering
Først indsendt
Først indsendt, der opfyldte QC-kriterier
Først opslået (Skøn)
Opdateringer af undersøgelsesjournaler
Sidste opdatering sendt (Skøn)
Sidste opdatering indsendt, der opfyldte kvalitetskontrolkriterier
Sidst verificeret
Mere information
Begreber relateret til denne undersøgelse
Andre undersøgelses-id-numre
- CHDR1212
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