Role of Interleukin (IL)-1 in Postprandial Fatigue - The Chäschüechli 2 Study (Chäs2)
2018年1月25日 更新者：University Hospital, Basel, Switzerland
Role of IL-1 in Postprandial Fatigue - The Chäschüechli 2 Study
Role of IL-1 in postprandial fatigue - The Chäschüechli 2 Study It is a randomized, single dose, placebo-controlled, double blind, cross-over, proof-of-concept study.
16 healthy young men will be included in this study. The objective of this study is to evaluate if severity of postprandial fatigue is driven by IL-1.
Since fatigue is associated with increased cytokine levels, and since fatigue in chronic inflammatory settings, such as type 2 diabetes, can be reduced by inhibition of IL-1β, postprandial fatigue might also respond to anti-inflammatory intervention with IL-1 inhibition.
The aim of the study is to investigate whether postprandial fatigue is, at least in part, driven by the IL-1 system.
調査の概要
研究の種類
介入
入学 (実際)
16
段階
- 適用できない
連絡先と場所
このセクションには、調査を実施する担当者の連絡先の詳細と、この調査が実施されている場所に関する情報が記載されています。
研究場所
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Basel、スイス、CH-4031 Basel
- University Hospital Basel, Department of Endocrinology, Diabetes and Metabolism
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参加基準
研究者は、適格基準と呼ばれる特定の説明に適合する人を探します。これらの基準のいくつかの例は、人の一般的な健康状態または以前の治療です。
適格基準
就学可能な年齢
20年～65年 (大人、高齢者)
健康ボランティアの受け入れ
はい
受講資格のある性別
男
説明
Inclusion Criteria:
Male subjects
- non-smoking
- apparently healthy
- BMI >18 and ≤28 kg/m2 or BMI >30 and ≤35 kg/m2
- Age 20-65 years
- Subject is usually eating breakfast and lunch
- Willingness to use contraceptive measures adequate to prevent the subject's partner from becoming pregnant during the study. Adequate contraceptive measures include hormonal methods used for two or more cycles prior to screening (e.g., oral contraceptive pills, contraceptive patch, or contraceptive vaginal ring), double barrier methods (e.g., contraceptive sponge, diaphragm used in conjunction with contraceptive foam or jelly, and condom used in conjunction with contraceptive foam or jelly), intrauterine methods (IUD) and sterilization (e.g., tubal ligation or a monogamous relationship with a vasectomized partner).
- Owner of a smartphone so they will be able to download and use the sleeping APP, Sleep cycle, prior to the study days.
Exclusion Criteria:
Subjects will be excluded from the study if they meet any of the following criteria:
- Night shift workers
- Subjects suffering from sleep disturbances
- Clinical signs of infection in the week before inclusion or history of infection during the last 2 months (CRP >5mg/l)
- Impaired fasting glucose (fasting plasma glucose >5.5mmol/l)
- Hematologic disease (leukocyte count < 1.5x109/l, hemoglobin <11 g/dl, platelets <100 x 103/ul)
- Kidney disease (creatinine > 1.5 mg/dl))
- Liver disease (transaminases >2x upper normal range)
- Heart disease
- Pulmonary disease
- Inflammatory disease
- History of carcinoma
- History of tuberculosis
- Alcohol consumption >40g/d
- Smoking
- Known allergy towards Kineret
- Known allergy to ingredients of the test meal
- Current treatment with any drug in the week before inclusion, including vitamin supplementation (especially vitamin C and E)
- Use of any investigational drug within 30 days prior to enrolment or within 5 half-lives of the investigational drug, whichever is longer
- Subject refusing or unable to give written informed consent
研究計画
このセクションでは、研究がどのように設計され、研究が何を測定しているかなど、研究計画の詳細を提供します。
研究はどのように設計されていますか？
デザインの詳細
- 主な目的：他の
- 割り当て：ランダム化
- 介入モデル：クロスオーバー割り当て
- マスキング：ダブル
武器と介入
参加者グループ / アーム |
介入・治療 |
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実験的：Normal BMI
Healthy young men, normal BMI (BMI >18 and ≤28 kg/m2) will receive interventions Anakinra and sodium Chloride (NaCl)
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Subjects will receive Anakinra infusion and afterwards they will be fed a very fat containing meal, and postprandial fatigue will be measured regularly until 3,5 hour after the meal.
他の名前：
subjects will receive NaCl infusion and afterwards they will be fed a very fat containing meal, and postprandial fatigue will be measured regularly until 3,5 hour after the meal.
他の名前：
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実験的：Overweight
Healthy young men (BMI >30 and ≤35 kg/m2) will receive interventions Anakinra and NaCl
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Subjects will receive Anakinra infusion and afterwards they will be fed a very fat containing meal, and postprandial fatigue will be measured regularly until 3,5 hour after the meal.
他の名前：
subjects will receive NaCl infusion and afterwards they will be fed a very fat containing meal, and postprandial fatigue will be measured regularly until 3,5 hour after the meal.
他の名前：
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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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The primary outcome is change in fatigue measured by the SSS (Stanford Sleepiness Scale) between groups treated with Anakinra vs. placebo
時間枠：7 to 9 days (change between study day 1 and study day 2)
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Fatigue will be measured by using the SSS (Stanford Sleepiness Scale)
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7 to 9 days (change between study day 1 and study day 2)
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二次結果の測定
結果測定 |
メジャーの説明 |
時間枠 |
|---|---|---|
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Change in postprandial glucose, insulin, C-peptide, glucagon-like Peptide (GLP)-1(active/total), GIP(active/total), PYY, IL-6, tumor necrosis factor (TNF)-alfa, sCRP and cortisol due to any treatment (Anakinra vs. saline).
時間枠：7 to 9 days (change between study day 1 and study day 2)
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Blood sampling
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7 to 9 days (change between study day 1 and study day 2)
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Change in heart rate due to any treatment (Anakinra vs. saline)
時間枠：7 to 9 days (change between study day 1 and study day 2)
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Pulse watch
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7 to 9 days (change between study day 1 and study day 2)
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Change in insulin due to any treatment (Anakinra vs. saline).
時間枠：7 to 9 days (change between study day 1 and study day 2)
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Blood sampling
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7 to 9 days (change between study day 1 and study day 2)
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Change in C-peptide due to any treatment (Anakinra vs. saline).
時間枠：7 to 9 days (change between study day 1 and study day 2)
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Blood sampling
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7 to 9 days (change between study day 1 and study day 2)
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Change in GLP-1(active/total) due to any treatment (Anakinra vs. saline).
時間枠：7 to 9 days (change between study day 1 and study day 2)
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Blood sampling
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7 to 9 days (change between study day 1 and study day 2)
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Change in GIP(active/total) due to any treatment (Anakinra vs. saline).
時間枠：7 to 9 days (change between study day 1 and study day 2)
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Blood sampling
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7 to 9 days (change between study day 1 and study day 2)
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Change in PYY due to any treatment (Anakinra vs. saline).
時間枠：7 to 9 days (change between study day 1 and study day 2)
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Blood sampling
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7 to 9 days (change between study day 1 and study day 2)
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Change in IL-6 due to any treatment (Anakinra vs. saline).
時間枠：7 to 9 days (change between study day 1 and study day 2)
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Blood sampling
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7 to 9 days (change between study day 1 and study day 2)
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Change in TNF-alfa due to any treatment (Anakinra vs. saline).
時間枠：7 to 9 days (change between study day 1 and study day 2)
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Blood sampling
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7 to 9 days (change between study day 1 and study day 2)
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Change in sCRP due to any treatment (Anakinra vs. saline).
時間枠：7 to 9 days (change between study day 1 and study day 2)
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Blood sampling
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7 to 9 days (change between study day 1 and study day 2)
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Change in cortisol due to any treatment (Anakinra vs. saline).
時間枠：7 to 9 days (change between study day 1 and study day 2)
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Blood sampling
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7 to 9 days (change between study day 1 and study day 2)
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協力者と研究者
ここでは、この調査に関係する人々や組織を見つけることができます。
捜査官
- 主任研究者：Marc Y Donath, MD、University Hospital, Basel, Switzerland
研究記録日
これらの日付は、ClinicalTrials.gov への研究記録と要約結果の提出の進捗状況を追跡します。研究記録と報告された結果は、国立医学図書館 (NLM) によって審査され、公開 Web サイトに掲載される前に、特定の品質管理基準を満たしていることが確認されます。
主要日程の研究
研究開始
2016年8月1日
一次修了 (実際)
2017年4月1日
研究の完了 (実際)
2017年4月3日
試験登録日
最初に提出
2016年9月26日
QC基準を満たした最初の提出物
2016年9月26日
最初の投稿 (見積もり)
2016年9月27日
学習記録の更新
投稿された最後の更新 (実際)
2018年1月29日
QC基準を満たした最後の更新が送信されました
2018年1月25日
最終確認日
2018年1月1日
詳しくは
本研究に関する用語
追加の関連 MeSH 用語
その他の研究ID番号
- EKNZ BASEC 2016-00816
個々の参加者データ (IPD) の計画
個々の参加者データ (IPD) を共有する予定はありますか?
いいえ
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Anakinraの臨床試験
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Mid and South Essex NHS Foundation TrustUniversity of East Anglia; National Institute for Health Research, United Kingdom; Anglia Ruskin... と他の協力者完了