Insulin ResistanceSIRSSNCT01134809
Skeletal Muscle Wasting and Insulin Resistance Following Surgical Stress
An observational study of Insulin Resistance, run by University of Nottingham at 1 site in United Kingdom.
Trial summary
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… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Insulin Resistance
- What is being tested?
- Major abdominal surgery
- Type of treatment
- Surgery or procedure
- How many people
- 15 participants
- Where
- 1 siteUnited Kingdom
- Study dates
- May 2010to May 2013
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: All adult patients having major abdominal surgery
Who may be able to join
- All adult patients undergoing major open elective gastrointestinal surgery lasting 3 hours or more will be eligible for the study.
Who cannot join
- Patients who are:
- undergoing emergency surgery
- suffering from chronic illness, (e.g. diabetes) or other debilitating diseases
- on long term anti-inflammatory drugs, (e.g. NSAIDS, Steroids, immunosuppressant)
- on long term antibiotics
- on statins
Show all 10Show fewer
- on full therapeutic dose of anticoagulants, or aspirin > 325 mg/day, clopidogrel > 75 mg/day
- suffering from bleeding diathesis
- unable to give consent
- pregnant or breastfeeding
Trial locations and contacts
1 site in 1 country.
United Kingdom1 site
University Hospitals Nottingham Queen's Medical Centre
Nottingham, Nottingham, NG7 2UH
About this study
Official title: 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.
Read the detailed description
Experimental plan Fifteen adult patients undergoing major open elective abdominal surgery will be included in this nonrandomized study.
Objectives:
- To study the expression proteins and metabolites involved in UPP mediated protein degradation, in blood and muscle biopsy samples.
- 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.
- Conditions
- Insulin Resistance
- Being tested
- Major abdominal surgery
- Keywords
- Major abdominal surgery
- Medical subject headings
- Insulin Resistance
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Major abdominal surgeryProcedure or surgery
All adult patients having major abdominal surgery
| Study group | Role | What they receive |
|---|---|---|
| Major abdominal surgery | Patients having major abdominal surgery Receives: Procedure: Major abdominal surgery |
What is being measured
The primary outcome is the main question the study is designed to answer.
postoperative insulin resistance
Measured: First week following surgery
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted2 Jun 2010 (estimated)
- Study startMay 2010
- Primary completionMay 2013
- Study completionMay 2013
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for Insulin ResistanceStudies of the same condition, open and under way.
- More trials run by University of NottinghamThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 15 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Nottingham
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Dileep N Lobo, Professor, Study chair, University of Notitngham
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01134809
- Sponsor's protocol ID
- 09106
- Acronym
- SIRSS
- Status last verified
- Jun 2015
- First submitted
- 28 May 2010
- Last updated
- 9 Jun 2015
- Results posted
- No
- Data monitoring committee
- Yes
Publications
Atkins R, Constantin-Teodosiu D, Varadhan KK, Constantin D, Lobo DN, Greenhaff PL. Major elective abdominal surgery acutely impairs lower limb muscle pyruvate dehydrogenase complex activity and mitochondrial function. Clin Nutr. 2021 Mar;40(3):1046-1051. doi: 10.1016/j.clnu.2020.07.006. Epub 2020 Jul 14.
PubMed 32711950Varadhan KK, Constantin-Teodosiu D, Constantin D, Greenhaff PL, Lobo DN. Inflammation-mediated muscle metabolic dysregulation local and remote to the site of major abdominal surgery. Clin Nutr. 2018 Dec;37(6 Pt A):2178-2185. doi: 10.1016/j.clnu.2017.10.020. Epub 2017 Nov 2.
PubMed 29129636
Study at a glance
From the registry record, last updated by the sponsor on 9 Jun 2015. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Does Surgical Stress Impair Skeletal Muscle Protein and Carbohydrate Metabolism?
- ClinicalTrials.gov ID
- NCT01134809
- Acronym / sponsor ID
- SIRSS / 09106
- Conditions
- Insulin Resistance
- Keywords
- Major abdominal surgery
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 15 participants (actual)
- Lead sponsor
- University of NottinghamUniversity, hospital or other
- Study start
- May 2010
- Primary completion
- May 2013 (actual)
- Study completion
- May 2013 (actual)
- First posted
- 2 Jun 2010 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
Experimental plan Fifteen adult patients undergoing major open elective abdominal surgery will be included in this nonrandomized study.
Objectives:
- To study the expression proteins and metabolites involved in UPP mediated protein degradation, in blood and muscle biopsy samples.
- 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 design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Major abdominal surgery | – | Procedure: Major abdominal surgeryPatients having major abdominal surgery |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- All adult patients having major abdominal surgery
Key inclusion criteria (1 listed)
- All adult patients undergoing major open elective gastrointestinal surgery lasting 3 hours or more will be eligible for the study.
Key exclusion criteria (10 listed)
- Patients who are:
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Major abdominal surgeryAll adult patients having major abdominal surgery | Procedure or surgery | Major abdominal surgery |
Primary outcome
postoperative insulin resistance
Time frame: First week following surgery
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 9 Jun 2015.
- Derived from this study: PubMed 32711950Atkins R, Constantin-Teodosiu D, Varadhan KK, Constantin D, Lobo DN, Greenhaff PL. Major elective abdominal surgery acutely impairs lower limb muscle pyruvate dehydrogenase complex activity and mitochondrial function. Clin Nutr. 2021 Mar;40(3):1046-1051. doi: 10.1016/j.clnu.2020.07.006. Epub 2020 Jul 14.
- Derived from this study: PubMed 29129636Varadhan KK, Constantin-Teodosiu D, Constantin D, Greenhaff PL, Lobo DN. Inflammation-mediated muscle metabolic dysregulation local and remote to the site of major abdominal surgery. Clin Nutr. 2018 Dec;37(6 Pt A):2178-2185. doi: 10.1016/j.clnu.2017.10.020. Epub 2017 Nov 2.
Related trials for Insulin Resistance
Active, not recruiting
Effect of Probiotics on Insulin Sensitivity in Overweight and Obese Pregnancy
Obesity & Overweight, Gestational Diabetes Mellitus (GDM)
Not yet recruitingPhase 2
Trial of the Combination of Alpha-Lipoic Acid and Mirabegron in Women and in Men With Obesity
Insulin Resistance, Obesity
Recruiting
Effects of Urolithin A Supplementation on Glucose Metabolism in Healthy Adults 55 >= Years Old: A Randomized Triple-Masked Controlled Clinical Trial
Healthy Volunteer
Not yet recruitingPhase 2
Effects of Meal Macronutrients on Postprandial Lipids
Nephrotic Syndrome, Lipodystrophy
RecruitingObservational study
Food-i-Sense Analytics: Integrating AI Into Continuous Glucose Monitoring Data Analysis for Precision Nutrition.
Prediabetes (Insulin Resistance, Impaired Glucose Tolerance), Artificial Intelligence Mobile Application
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Dileep N Lobo, Professor study chair
University of Notitngham
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Insulin Resistance, run by University of Nottingham at 1 site in United Kingdom.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 10 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 9 Jun 2015. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United Kingdom. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
postoperative insulin resistance (time frame: First week following surgery). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT01134809, which also lists 2 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 9 Jun 2015.