Skeletal Muscle Wasting and Insulin Resistance Following Surgical Stress (SIRSS)

June 5, 2015 updated by: University of Nottingham

Does Surgical Stress Impair Skeletal Muscle Protein and Carbohydrate Metabolism?

Background: Skeletal muscle wasting or decrease in muscle mass occurs as a result of alteration in the body's mechanisms to make or break muscle protein. In animal models, the pathway termed as 'ubiquitin-proteasome pathway' (UPP) is primarily responsible for the regulation of skeletal muscle protein loss in wasting conditions and during infection(sepsis). Skeletal muscle wasting is noticed in patients having major surgery due to the inflammatory reaction triggered by special group of proteins called cytokines (inflammatory proteins), resulting in reduced muscle strength, impaired capacity to fight infections, change in bowel function, increased clinical complications and prolonged recovery. Major surgery also leads to decreased sensitivity to hormone known as insulin, resulting in 'diabeteslike'state.

We hypothesize that susceptibility of patients undergoing major abdominal surgery, to skeletal muscle wasting and insulin resistance, is determined by stress response to surgery over time, leading to changes in the pathways that make or break muscle protein, namely the Akt/Foxo signalling and UPP. Therefore, the aim of this study is to establish the underlying mechanisms of skeletal muscle wasting and insulin resistance in patients undergoing major abdominal surgery.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Detailed Description

Experimental plan Fifteen adult patients undergoing major open elective abdominal surgery will be included in this nonrandomized study.

Objectives:

  1. To study the expression proteins and metabolites involved in UPP mediated protein degradation, in blood and muscle biopsy samples.
  2. To correlate the effects of surgery on the release of bacteria in blood from the bowel.

The analysis of the samples will include the following techniques, namely, RTPCR, ELISA, western blotting and metabolomics.

Establishing the association between these signaling mechanisms and expression of the individual proteins secondary to inflammation following surgery and infection would enable application of suitable therapeutic strategies that could reduce the inflammatory response to benefit all patients undergoing surgery.

Study Type

Observational

Enrollment (Actual)

15

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United Kingdom
      • Nottingham, United Kingdom, NG7 2UH
        • University Hospitals Nottingham Queen's Medical Centre

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Sampling Method

Non-Probability Sample

Study Population

All adult patients having major abdominal surgery

Description

Inclusion Criteria:

  • All adult patients undergoing major open elective gastrointestinal surgery lasting 3 hours or more will be eligible for the study.

Exclusion Criteria:

  • Patients who are:

    1. undergoing emergency surgery
    2. suffering from chronic illness, (e.g. diabetes) or other debilitating diseases
    3. on long term anti-inflammatory drugs, (e.g. NSAIDS, Steroids, immunosuppressant)
    4. on long term antibiotics
    5. on statins
    6. on full therapeutic dose of anticoagulants, or aspirin > 325 mg/day, clopidogrel > 75 mg/day
    7. suffering from bleeding diathesis
    8. unable to give consent
    9. pregnant or breastfeeding

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Observational Models: Cohort
  • Time Perspectives: Prospective

Cohorts and Interventions

Group / Cohort
Intervention / Treatment
Major abdominal surgery
Patients having major abdominal surgery
Procedure: Major abdominal surgery
All adult patients having major abdominal surgery

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
postoperative insulin resistance
Time Frame: First week following surgery
First week following surgery

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

University of Nottingham

Investigators

  • Study Chair: Dileep N Lobo, Professor, University of Notitngham

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

May 1, 2010

Primary Completion (Actual)

May 1, 2013

Study Completion (Actual)

May 1, 2013

Study Registration Dates

First Submitted

May 28, 2010

First Submitted That Met QC Criteria

June 1, 2010

First Posted (Estimate)

June 2, 2010

Study Record Updates

Last Update Posted (Estimate)

June 9, 2015

Last Update Submitted That Met QC Criteria

June 5, 2015

Last Verified

June 1, 2015

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 09106

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

Clinical Trials on Insulin Resistance

Clinical Trials on Major abdominal surgery

Search Similar Trials

Sponsors and Collaborators

Medical Conditions

Drug Interventions

CROs by country

CROs in Rwanda

Conditions

Rare Diseases

Drug Interventions

Dietary Supplements

Sponsor/Collaborators

Locations

Subscribe