Ex vivo LPS stimulation in healthy and compromised subjects

Withdrawn

• Conditions: diabetes; overweight; 10018424

• Registration Number: NL-OMON36944
• Lead Sponsor: TNO

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Last Update Posted: 29 April 2024

Recruitment & Eligibility

• Status: Withdrawn
• Sex: Not specified
• Target Recruitment: 36

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 <= 5.5% (37 mmol/mol) or fasting glucose >= 3.4 and <= 5.6 mmol/L ; further the waist circumference < 94 cm; and body fat percentage between 8-24.9%.
-The prediabetics with overweight meet the following criteria: HbA1c in the range of 6.0 - 6.5% (42 - 48mmol/mol) Or fasting glucose in the range of 6.1-6.9 mmol/L; further the waist circumference >= 102 cm; and body fat percentage >= 25 %.

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)

Study & Design

• Study Type: Observational invasive
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
<p>After ex vivo LPS stimulation of blood samples, cytokine parameters including<br /><br>TNF-a, IL-6, IL-1&beta;, IL-10, IL-8, IFN-gamma, IL-12 and IL-1RA will be measured.</p><br>

Secondary Outcome Measures

Name	Time	Method
<p>Not applicable.</p><br>