Investigating whether the magnitude of postoperative inflammatory and insulin resistant responses is related to body composition and physiological function of skeletal muscle and adipose tissue

Not Applicable

Completed

• Conditions: Topic: Generic Health Relevance and Cross Cutting Themes; Subtopic: Generic Health Relevance (all Subtopics); Disease: Surgery; Injury, Occupational Diseases, Poisoning; Complications of surgical and medical care

• Registration Number: ISRCTN16597586
• Lead Sponsor: niversity of Nottingham (UK)

Brief Summary

2018 results in https://www.ncbi.nlm.nih.gov/pubmed/29454501

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2011-11-25
• Study Completion: 2013-09-28
• Last Update Posted: 18 June 2018

Recruitment & Eligibility

• Status: Completed
• Sex: All
• Target Recruitment: 32

Inclusion Criteria

1. Age 18-75 years
2. Correct body mass index (BMI) and waist circumference criteria (Obese group ? BMI >=30 or waist circumference > 94 cm in men and > 80 cm in women. Non obese group ? BMI 18.5-25) or
3. Waist circumference (<=94cm in men and <=80 cm in women)
4. Due to undergo elective major abdominal surgery
5. American Society of Anaesthesiologists physical status (ASA IIII)
6. Caucasian patients
7. Able to give informed consent and comply with study protocol
Target Gender: Male & Female; Upper Age Limit 75 years ; Lower Age Limit 18 years

Exclusion Criteria

1. History of significant preoperative weight loss (>10% over preceding 3 months )
2. Clinical history of pulmonary aspiration
3. Known gastrooesophageal reflux disease (GORD) or hiatus hernia
4. History of difficult intubation or conditions leading to the latter such as: previous neck radiotherapy/rheumatoid arthritis/presence of thyroid goitre
5. Metabolic disorders (e.g. diabetes mellitus, thyroid disease, Cushing?s Syndrome)
6. Simultaneous participation in another clinical study or involvement in a clinical study within the preceding 3 months
6. Patients with suspicion of alcohol/drug abuse
7. Pregnancy

Study & Design

• Study Type: Interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Within subject differences in perioperative insulin sensitivity amongst obese, non-obese, carbohydrate loaded and non carbohydrate-loaded patients. Timepoint(s): End of study

Secondary Outcome Measures

Name	Time	Method
1. The correlation between body composition and changes in perioperative insulin sensitivity<br>2. Differences in cytokine gene expression<br>3. Differences in muscle and fat genes and protein expression<br>4. The incidence of post-operative infectious and non-infectious complications<br>5. Differences between the groups in length of hospital stay