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Mechanisms Underlying Postoperative Insulin Resistance and Inflammation

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT01470534
Recruitment Status : Unknown
Verified October 2012 by University of Nottingham.
Recruitment status was:  Recruiting
First Posted : November 11, 2011
Last Update Posted : October 5, 2012
Sponsor:
Information provided by (Responsible Party):
University of Nottingham

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).


Condition or disease Intervention/treatment Phase
Obesity Dietary Supplement: carbohydrate drink Procedure: Muscle biopsy Procedure: Blood sampling Dietary Supplement: Placebo Phase 4

Detailed Description:

Interested participants who are undergoing abdominal (tummy) surgery will be recruited from surgical clinics. They will be asked to attend the Greenfield Human Physiology Laboratory where they will be asked to complete two questionnaires. In addition, a sample of blood, and a small sample of muscle and fat from their thigh will be taken. They will undergo a low dose X-ray (DXA scan) and an insulin clamp. The insulin clamp involves being connected to an insulin and glucose drip for around four hours during which their blood pressure and pulse is monitored and regular blood samples are taken.

Participants will be allocated randomly to one of two groups. One group will receive a carbohydrate (sugar) drink before surgery and the other group will receive a dummy (placebo) drink.

On the day of surgery, pre-operative checks and assessment will proceed as normal. After the participant is asleep under anaesthetic, a blood sample and tummy muscle and fat samples will be taken by the surgeon through the surgical incision. At the end of surgery, another blood sample and muscle and fat samples from the tummy and thigh will be taken while the participant is still under anaesthetic.

On the day after surgery, a further blood test and tummy and thigh muscle and fat sample will be taken. Participants will also undergo another insulin clamp.

The research team will follow participants' progress after surgery, but the decision to allow them home will be made by the medical team responsible for their care.

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 32 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary Purpose: Basic Science
Official Title: Investigating Whether the Magnitude of Postoperative Inflammatory and Insulin Resistant Responses is Related to Body Composition and Physiological Function of Skeletal Muscle & Adipose Tissue
Study Start Date : November 2011
Estimated Primary Completion Date : November 2012
Estimated Study Completion Date : November 2012

Resource links provided by the National Library of Medicine

Drug Information available for: Insulin

Arm Intervention/treatment
Experimental: Normal body weight Dietary Supplement: carbohydrate drink
carbohydrate drink

Procedure: Muscle biopsy
Open muscle biopsy

Procedure: Blood sampling
Venopuncture

Experimental: Obese Dietary Supplement: carbohydrate drink
carbohydrate drink

Procedure: Muscle biopsy
Open muscle biopsy

Procedure: Blood sampling
Venopuncture

Placebo Comparator: Normal Body Weight placebo
Participants of mormal body weight given placebo
Procedure: Muscle biopsy
Open muscle biopsy

Procedure: Blood sampling
Venopuncture

Dietary Supplement: Placebo
Placebo Comparator: Obese placebo
Participants who are obese given placebo
Procedure: Muscle biopsy
Open muscle biopsy

Procedure: Blood sampling
Venopuncture

Dietary Supplement: Placebo



Primary Outcome Measures :
  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. [ Time Frame: 2 weeks ]

Secondary Outcome Measures :
  1. Correlation between body composition and changes in perioperative insulin sensitivity [ Time Frame: 2 weeks ]
  2. Differences in inflammatory cytokine gene expression [ Time Frame: 2 months ]
  3. Differences in muscle and fat genes and proteins controlling carbohydrate/fat oxidation and insulin signalling [ Time Frame: 3 months ]
  4. Differences activities of muscle and fat enzymes involved in carbohydrate/fat/carnitine metabolism [ Time Frame: 2 months ]
  5. Differences in the aforementioned between peripheral and central fat and muscle [ Time Frame: 2 months ]
  6. The incidence of post-operative infectious and non-infectious complications [ Time Frame: 30 days ]
  7. Length of hospital stay (difference between groups) [ Time Frame: 6 weeks ]


Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 75 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • 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

Exclusion Criteria:

  • 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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01470534


Locations
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United Kingdom
University of Nottingham Recruiting
Nottingham, United Kingdom, NG7 2UH
Contact: Dileep Lobo       dileep.lobo@nottingham.ac.uk   
Principal Investigator: Dileep Lodo         
Sponsors and Collaborators
University of Nottingham

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Responsible Party: University of Nottingham
ClinicalTrials.gov Identifier: NCT01470534    
Other Study ID Numbers: 11040
First Posted: November 11, 2011    Key Record Dates
Last Update Posted: October 5, 2012
Last Verified: October 2012
Keywords provided by University of Nottingham:
Dietary supplement
Carbohydrate loading
Insulin resistance
Surgery
Additional relevant MeSH terms:
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Insulin Resistance
Hyperinsulinism
Glucose Metabolism Disorders
Metabolic Diseases
Insulin
Hypoglycemic Agents
Physiological Effects of Drugs