Mechanisms Underlying Postoperative Insulin Resistance and Inflammation
Investigating Whether the Magnitude of Postoperative Inflammatory and Insulin Resistant Responses is Related to Body Composition and Physiological Function of Skeletal Muscle & Adipose Tissue
Having an operation places an enormous burden on the body, leading to the development of inflammation and so called 'insulin resistance'. Insulin resistance means the body is unable to respond to important hormones that control use of energy. Recent studies have shown that patients who develop 'higher' insulin resistance and inflammation have more serious complications and take longer to recover after surgery. The investigators do not know what controls the development of insulin resistance and inflammation after surgery. Similarly, the investigators do not know why certain patients develop much more insulin resistance and inflammation than others, even though they have the same operation.
The main purpose of the study is to try to find out which patients are prone to developing greater 'amounts' of insulin resistance and inflammation. The investigators also want to find out whether the investigators can reduce the 'amount' of insulin resistance and inflammation in these patients (for example by giving them carbohydrate [sugar-based] drinks before surgery - these have been shown to reduce insulin resistance in some patient groups).
Information from this study should improve the way the investigators prepare patients before surgery and this should help to improve patient outcomes following surgery (by reducing complications and speeding recovery after major surgery).
調査の概要
状態
条件
詳細な説明
Interested participants who are undergoing abdominal (tummy) surgery will be recruited from surgical clinics. They will be asked to attend the Greenfield Human Physiology Laboratory where they will be asked to complete two questionnaires. In addition, a sample of blood, and a small sample of muscle and fat from their thigh will be taken. They will undergo a low dose X-ray (DXA scan) and an insulin clamp. The insulin clamp involves being connected to an insulin and glucose drip for around four hours during which their blood pressure and pulse is monitored and regular blood samples are taken.
Participants will be allocated randomly to one of two groups. One group will receive a carbohydrate (sugar) drink before surgery and the other group will receive a dummy (placebo) drink.
On the day of surgery, pre-operative checks and assessment will proceed as normal. After the participant is asleep under anaesthetic, a blood sample and tummy muscle and fat samples will be taken by the surgeon through the surgical incision. At the end of surgery, another blood sample and muscle and fat samples from the tummy and thigh will be taken while the participant is still under anaesthetic.
On the day after surgery, a further blood test and tummy and thigh muscle and fat sample will be taken. Participants will also undergo another insulin clamp.
The research team will follow participants' progress after surgery, but the decision to allow them home will be made by the medical team responsible for their care.
研究の種類
入学 (予想される)
段階
- フェーズ 4
連絡先と場所
研究場所
-
-
-
Nottingham、イギリス、NG7 2UH
- 募集
- University of Nottingham
-
コンタクト：
- Dileep Lobo
- メール：dileep.lobo@nottingham.ac.uk
-
主任研究者：
- Dileep Lodo
-
-
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
説明
Inclusion Criteria:
- Age 18-75 yrs
- Correct BMI and waist circumference criteria : Obese group - BMI ≥30 AND waist circumference ≥94 cm in men and ≥ 80 cm in women, Non obese group - BMI 18.5-25 AND waist circumference ≤94cm in men and ≤80 cm in women Due to undergo elective major abdominal surgery ASA I-III Caucasian patients Able to give informed consent and comply with study protocol
Exclusion Criteria:
History of significant preoperative weight loss (>10% over preceding 3 weeks)
- Clinical history of pulmonary aspiration
- Known gastro-oesophageal reflux disease (GORD) or hiatus hernia
- History of difficult intubation or conditions leading to the latter such as: previous neck radiotherapy/rheumatoid arthritis/presence of thyroid goitre
- Metabolic disorders (e.g. diabetes mellitus, thyroid disease, Cushing's Syndrome)
- Simultaneous participation in another clinical study or involvement in a clinical study within the preceding 3 months,
- Patients with suspicion of alcohol/drug abuse
- Pregnancy
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
- 主な目的：基礎科学
- 割り当て：ランダム化
- 介入モデル：並列代入
- 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 |
|---|---|
|
実験的：肥満
|
carbohydrate drink
Open muscle biopsy
Venopuncture
|
|
実験的：Normal body weight
|
carbohydrate drink
Open muscle biopsy
Venopuncture
|
|
プラセボコンパレーター：Normal Body Weight placebo
Participants of mormal body weight given placebo
|
Open muscle biopsy
Venopuncture
|
|
プラセボコンパレーター：Obese placebo
Participants who are obese given placebo
|
Open muscle biopsy
Venopuncture
|
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 |
時間枠 |
|---|---|
|
Within subject differences in perioperative insulin sensitivity (M-value, corrected for insulin concentrations) amongst obese, non-obese, carbohydrate loaded and non-carbohydrate loaded patients.
時間枠：2 weeks
|
2 weeks
|
二次結果の測定
結果測定 |
時間枠 |
|---|---|
|
Correlation between body composition and changes in perioperative insulin sensitivity
時間枠：2 weeks
|
2 weeks
|
|
Differences in inflammatory cytokine gene expression
時間枠：2 months
|
2 months
|
|
Differences in muscle and fat genes and proteins controlling carbohydrate/fat oxidation and insulin signalling
時間枠：3 months
|
3 months
|
|
Differences activities of muscle and fat enzymes involved in carbohydrate/fat/carnitine metabolism
時間枠：2 months
|
2 months
|
|
Differences in the aforementioned between peripheral and central fat and muscle
時間枠：2 months
|
2 months
|
|
The incidence of post-operative infectious and non-infectious complications
時間枠：30 days
|
30 days
|
|
Length of hospital stay (difference between groups)
時間枠：6 weeks
|
6 weeks
|
協力者と研究者
スポンサー
研究記録日
主要日程の研究
研究開始
一次修了 (予想される)
研究の完了 (予想される)
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
この情報は、Web サイト clinicaltrials.gov から変更なしで直接取得したものです。研究の詳細を変更、削除、または更新するリクエストがある場合は、register@clinicaltrials.gov。 までご連絡ください。 clinicaltrials.gov に変更が加えられるとすぐに、ウェブサイトでも自動的に更新されます。
プラセボの臨床試験
-
Palacky University完了
-
Universidade Federal do ParaConselho Nacional de Desenvolvimento Científico e Tecnológico完了
-
Advice Pharma Group srl積極的、募集していない肥満 | 栄養障害 | 体重 | 減量 | 食生活 | 太りすぎと肥満 | 健康行動 | ダイエット、健康 | ダイエット習慣 | ライフスタイル | 栄養、健康 | 行動障害イタリア
-
University Hospital, Strasbourg, France積極的、募集していない