ObesityPhase 4NCT01470534
Mechanisms Underlying Postoperative Insulin Resistance and Inflammation
A Phase 4 study testing carbohydrate drink, Muscle biopsy and Blood sampling in people with Obesity, run by University of Nottingham at 1 site in United Kingdom.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 75 years
- Conditions the study is for
- Obesity
- What is being tested?
- carbohydrate drink, Muscle biopsy and Blood sampling
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 32 participants
- Where
- 1 siteUnited Kingdom
- Study dates
- Nov 2011to Nov 2012
- Phase
- Phase 4
- 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 to 75 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
United Kingdom1 site, 1 recruiting
- Recruiting
University of Nottingham
Nottingham, NG7 2UH
Dileep Lobo, dileep.lobo@nottingham.ac.uk
Dileep Lodo
About this study
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
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).
Read the 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.
- Conditions
- Obesity
- Being tested
- carbohydrate drink, Muscle biopsy, Blood sampling, Placebo
- Keywords
- Dietary supplement, Carbohydrate loading, Insulin resistance, Surgery
- Medical subject headings
- Obesity, Insulin Resistance
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
carbohydrate drinkDietary supplement
carbohydrate drink
Muscle biopsyProcedure or surgery
Open muscle biopsy
Blood samplingProcedure or surgery
Venopuncture
PlaceboDietary supplement
| Study group | Role | What they receive |
|---|---|---|
| Normal body weight | Experimental | Not described Receives: Dietary Supplement: carbohydrate drink; Procedure: Muscle biopsy; Procedure: Blood sampling |
| Obese | Experimental | Not described Receives: Dietary Supplement: carbohydrate drink; Procedure: Muscle biopsy; Procedure: Blood sampling |
| Normal Body Weight placebo | Placebo comparator | Participants of mormal body weight given placebo Receives: Procedure: Muscle biopsy; Procedure: Blood sampling; Dietary Supplement: Placebo |
| Obese placebo | Placebo comparator | Participants who are obese given placebo Receives: Procedure: Muscle biopsy; Procedure: Blood sampling; Dietary Supplement: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
Within subject differences in perioperative insulin sensitivity (M-value, corrected for insulin concentrations) amongst obese, non-obese, carbohydrate loaded and non-carbohydrate loaded patients.
Measured: 2 weeks
Secondary outcomes (7)
Correlation between body composition and changes in perioperative insulin sensitivity
Measured: 2 weeks
Differences in inflammatory cytokine gene expression
Measured: 2 months
Differences in muscle and fat genes and proteins controlling carbohydrate/fat oxidation and insulin signalling
Measured: 3 months
Differences activities of muscle and fat enzymes involved in carbohydrate/fat/carnitine metabolism
Measured: 2 months
Differences in the aforementioned between peripheral and central fat and muscle
Measured: 2 months
The incidence of post-operative infectious and non-infectious complications
Measured: 30 days
Length of hospital stay (difference between groups)
Measured: 6 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted11 Nov 2011 (estimated)
- Study startNov 2011
- Primary completionNov 2012 (estimated)
- Study completionNov 2012 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for ObesityStudies 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
- Interventional
- Phase
- Phase 4
- Primary purpose
- Basic science
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 32 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University of Nottingham
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01470534
- Sponsor's protocol ID
- 11040
- Status last verified
- Oct 2012
- First submitted
- 9 Nov 2011
- Last updated
- 5 Oct 2012
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 5 Oct 2012. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT01470534
- Acronym / sponsor ID
- 11040
- Conditions
- Obesity
- Keywords
- Dietary supplement, Carbohydrate loading, Insulin resistance, Surgery
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 32 participants (estimated)
- Lead sponsor
- University of NottinghamUniversity, hospital or other
- Study start
- Nov 2011
- Primary completion
- Nov 2012 (estimated)
- Study completion
- Nov 2012 (estimated)
- First posted
- 11 Nov 2011 (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.
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).
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.
Study design
- Primary purpose
- Basic science
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, investigator)
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| 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 | Procedure: Muscle biopsy, Procedure: Blood sampling, Dietary Supplement: PlaceboParticipants of mormal body weight given placebo |
| Obese placebo | Placebo comparator | Procedure: Muscle biopsy, Procedure: Blood sampling, Dietary Supplement: PlaceboParticipants who are obese given placebo |
Who may qualify
- Ages
- 18 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- 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
Key exclusion criteria (8 listed)
- History of significant preoperative weight loss (>10% over preceding 3 weeks)
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 |
|---|---|---|
| carbohydrate drinkcarbohydrate drink | Dietary supplement | Normal body weight, Obese |
| Muscle biopsyOpen muscle biopsy | Procedure or surgery | Normal Body Weight placebo, Normal body weight, Obese, Obese placebo |
| Blood samplingVenopuncture | Procedure or surgery | Normal Body Weight placebo, Normal body weight, Obese, Obese placebo |
| Placebo | Dietary supplement | Normal Body Weight placebo, Obese placebo |
Primary outcome
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
7 secondary outcomes
Correlation between body composition and changes in perioperative insulin sensitivity
Time frame: 2 weeks
Differences in inflammatory cytokine gene expression
Time frame: 2 months
Differences in muscle and fat genes and proteins controlling carbohydrate/fat oxidation and insulin signalling
Time frame: 3 months
Differences activities of muscle and fat enzymes involved in carbohydrate/fat/carnitine metabolism
Time frame: 2 months
Differences in the aforementioned between peripheral and central fat and muscle
Time frame: 2 months
The incidence of post-operative infectious and non-infectious complications
Time frame: 30 days
Length of hospital stay (difference between groups)
Time frame: 6 weeks
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 5 Oct 2012.
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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.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing carbohydrate drink, Muscle biopsy and Blood sampling in people with Obesity, 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 2 inclusion and 8 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: status not confirmed, as of the sponsor's last update on 5 Oct 2012. 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. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Each site lists its own contact: choose the nearest one under Trial locations. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
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). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 5 Oct 2012.