Mechanisms Underlying Postoperative Insulin Resistance and Inflammation
NCT ID: NCT01470534
Last Updated: 2012-10-05
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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UNKNOWN
PHASE4
32 participants
INTERVENTIONAL
2011-11-30
2012-11-30
Brief Summary
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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).
Detailed Description
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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.
Conditions
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Keywords
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Study Design
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RANDOMIZED
PARALLEL
BASIC_SCIENCE
DOUBLE
Study Groups
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Normal body weight
carbohydrate drink
carbohydrate drink
Muscle biopsy
Open muscle biopsy
Blood sampling
Venopuncture
Obese
carbohydrate drink
carbohydrate drink
Muscle biopsy
Open muscle biopsy
Blood sampling
Venopuncture
Normal Body Weight placebo
Participants of mormal body weight given placebo
Muscle biopsy
Open muscle biopsy
Blood sampling
Venopuncture
Placebo
Obese placebo
Participants who are obese given placebo
Muscle biopsy
Open muscle biopsy
Blood sampling
Venopuncture
Placebo
Interventions
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carbohydrate drink
carbohydrate drink
Muscle biopsy
Open muscle biopsy
Blood sampling
Venopuncture
Placebo
Eligibility Criteria
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Inclusion Criteria
* 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
* 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
18 Years
75 Years
ALL
No
Sponsors
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University of Nottingham
OTHER
Responsible Party
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Locations
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University of Nottingham
Nottingham, , United Kingdom
Countries
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Facility Contacts
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Dileep Lobo
Role: primary
Other Identifiers
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11040
Identifier Type: -
Identifier Source: org_study_id