Mechanisms Underlying Postoperative Insulin Resistance and Inflammation

NCT01470534 | Unknown Phase 4 DMC

• 1 other identifier: 11040
• Study Type: interventional
• Target: 32
• Locations: 1 country
• Sites: 1

Brief Summary

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).

Conditions

Obesity

Keywords

Dietary supplement; Carbohydrate loading; Insulin resistance; Surgery

Outcome Measures

Primary Outcomes (1)

• Within subject differences in perioperative insulin sensitivity (M-value, corrected for insulin concentrations) amongst obese, non-obese, carbohydrate loaded and non-carbohydrate loaded patients.

  2 weeks

Secondary Outcomes (7)

• Correlation between body composition and changes in perioperative insulin sensitivity

  2 weeks

• Differences in inflammatory cytokine gene expression

  2 months

• Differences in muscle and fat genes and proteins controlling carbohydrate/fat oxidation and insulin signalling

  3 months

• Differences activities of muscle and fat enzymes involved in carbohydrate/fat/carnitine metabolism

  2 months

• Differences in the aforementioned between peripheral and central fat and muscle

  2 months

Study Arms (4)

Normal body weight

EXPERIMENTAL

Dietary Supplement: carbohydrate drink; Procedure: Muscle biopsy; Procedure: Blood sampling

Obese

EXPERIMENTAL

Dietary Supplement: carbohydrate drink; Procedure: Muscle biopsy; Procedure: Blood sampling

Normal Body Weight placebo

PLACEBO COMPARATOR

Participants of mormal body weight given placebo

Procedure: Muscle biopsy; Procedure: Blood sampling; Dietary Supplement: Placebo

Obese placebo

PLACEBO COMPARATOR

Participants who are obese given placebo

Procedure: Muscle biopsy; Procedure: Blood sampling; Dietary Supplement: Placebo

Interventions

carbohydrate drink DIETARY_SUPPLEMENT

carbohydrate drink

Normal body weight; Obese

Muscle biopsy PROCEDURE

Open muscle biopsy

Normal Body Weight placebo; Normal body weight; Obese; Obese placebo

Blood sampling PROCEDURE

Venopuncture

Normal Body Weight placebo; Normal body weight; Obese; Obese placebo

Placebo DIETARY_SUPPLEMENT

Normal Body Weight placebo; Obese placebo

Eligibility Criteria

• Age: 18 Years - 75 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• University of Nottingham: lead

Study Sites (1)

University of Nottingham

Nottingham, NG7 2UH, United Kingdom

RECRUITING

MeSH Terms

Conditions

Obesity; Insulin Resistance

Interventions

Blood Specimen Collection

Condition Hierarchy (Ancestors)

Overweight; Overnutrition; Nutrition Disorders; Nutritional and Metabolic Diseases; Body Weight; Signs and Symptoms; Pathological Conditions, Signs and Symptoms; Hyperinsulinism; Glucose Metabolism Disorders; Metabolic Diseases

Intervention Hierarchy (Ancestors)

Specimen Handling; Clinical Laboratory Techniques; Diagnostic Techniques and Procedures; Diagnosis; Punctures; Surgical Procedures, Operative; Investigative Techniques

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Purpose: BASIC SCIENCE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: November 9, 2011
• First Posted: November 11, 2011
• Study Start: November 1, 2011
• Primary Completion: November 1, 2012
• Study Completion: November 1, 2012
• Last Updated: October 5, 2012

Record last verified: 2012-10

Locations

GB (1)