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

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: a randomised controlled trial

Status

Active, not recruiting

Phases

Unknown

Study type

Interventional

Source

ISRCTN

Registry ID

ISRCTN16597586

Enrollment

Registered

2011-11-25

Start date

2011-09-28

Completion date

Unknown

Last updated

2018-06-18

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Topic: Generic Health Relevance and Cross Cutting Themes

Interventions

Preoperative carbohydrate load, Single intervention: Preoperative carbohydrate loading using a commercially available preparation given to patients undergoing abdominal surgery. Participants will rece

Eligibility

Sex/Gender

All

Inclusion criteria

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

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

Design outcomes

Primary

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

Secondary

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

Countries

United Kingdom

Outcome results

None listed

Source: ISRCTN (via WHO ICTRP) · Data processed: Feb 4, 2026