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Ex vivo LPS stimulation in healthy and compromised subjects

Ex vivo LPS stimulation in healthy and compromised subjects - Ex vivo LPS stimulation study

Status
Unknown
Phases
Unknown
Study type
Observational
Source
NL-OMON
Registry ID
NL-OMON36944
Enrollment
36
Registered
2012-07-11
Start date
2012-07-15
Completion date
Unknown
Last updated
2024-04-29

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

diabetes overweight

Interventions

None listed

Sponsors

TNO
Lead Sponsor

Eligibility

Age
18 Years to 99 Years

Inclusion criteria

Inclusion criteria: - Males - aged 35 to 45 years, on study day 1 - Healthy voluenteers are defined based on medical history evaluation, physical examination, results of the pre-study laboratory tests and a health and lifestyle questionnaire, with following criteria: HbA1c = 3.4 and = 102 cm; and body fat percentage >= 25 %.

Exclusion criteria

Exclusion criteria: -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; -Use of any medication 14 days before day 01; use of paracetamol 7 days before day 01. -Currently smoking or stopped smoking less than 6 months ago -Alcohol consumption >= 21 units per week -Exercise more than five hours per week -Use of dietary supplements (e.g. fish oil capsules, polyphenols and vitamins)

Design outcomes

Primary

MeasureTime frame
After ex vivo LPS stimulation of blood samples, cytokine parameters including TNF-a, IL-6, IL-1β, IL-10, IL-8, IFN-gamma, IL-12 and IL-1RA will be measured.—

Secondary

MeasureTime frame
Not applicable.—

Countries

Netherlands

Outcome results

None listed

Source: NL-OMON (via WHO ICTRP)