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.
調査の概要
研究の種類
入学 (実際)
連絡先と場所
研究場所
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Zuid-Holland
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Leiden、Zuid-Holland、オランダ、2333 CH
- CHDR
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参加基準
適格基準
就学可能な年齢
健康ボランティアの受け入れ
受講資格のある性別
サンプリング方法
調査対象母集団
説明
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.
研究計画
研究はどのように設計されていますか?
デザインの詳細
コホートと介入
グループ/コホート |
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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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この研究は何を測定していますか?
主要な結果の測定
結果測定 |
メジャーの説明 |
時間枠 |
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Cytokines
時間枠:baseline, 4h and 24h incubation with ex vivo LPS
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The levels of interleukines present in healthy and compromised subjects will be determined in a baseline sample.
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baseline, 4h and 24h incubation with ex vivo LPS
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協力者と研究者
スポンサー
捜査官
- 主任研究者:Pierre Peeters, PhD、CHDR Leiden
出版物と役立つリンク
研究記録日
主要日程の研究
研究開始
一次修了 (実際)
研究の完了 (実際)
試験登録日
最初に提出
QC基準を満たした最初の提出物
最初の投稿 (見積もり)
学習記録の更新
投稿された最後の更新 (見積もり)
QC基準を満たした最後の更新が送信されました
最終確認日
詳しくは
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