To determine whether a difference in resilience of inflammatory tone between healthy and prediabetic males can be identified with whole blood ex vivo LPS stimulation.
ID
Source
Brief title
Condition
- Glucose metabolism disorders (incl diabetes mellitus)
- Glucose metabolism disorders (incl diabetes mellitus)
Synonym
Research involving
Sponsors and support
Intervention
Outcome measures
Primary outcome
After ex vivo LPS stimulation of blood samples, cytokine parameters including
TNF-α, IL-6, IL-1β, IL-10, IL-8, IFN-gamma, IL-12 and IL-1RA will be measured.
Secondary outcome
Not applicable.
Background summary
It is hypothesized that 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 prediabetic overweight population. Possibly
certain dietary intervention can be applied to influence on the cytokine
parameters to improve the condition of health compromised group.
Study objective
To determine whether a difference in resilience of inflammatory tone between
healthy and prediabetic males can be identified with whole blood ex vivo LPS
stimulation.
Study design
This is a single centre, observational, case-control study with whole blood ex
vivo LPS challenge. No intervention will be administered.
Study burden and risks
As there is no investigational product for intervention, clinically relevant
side effects will not be expected.
The medical screening may result in unexpected findings.
P.O. Box 360 48
Zeist 3704HE
NL
P.O. Box 360 48
Zeist 3704HE
NL
Listed location countries
Age
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)
Design
Recruitment
Followed up by the following (possibly more current) registration
No registrations found.
Other (possibly less up-to-date) registrations in this register
No registrations found.
In other registers
| Register | ID |
|---|---|
| CCMO | NL40983.058.12 |