Diabetes Mellitus Type 2NCT02863276
Modulating the Stress Response in Diabetes Mellitus Type 2 Patients Undergoing Colon Surgery
A study testing Intensified insulin therapy in people with Diabetes Mellitus Type 2 and Insulin Resistance, run by University Hospital, Basel, Switzerland.
Trial summary
Background Surgical injury provokes a stress response. These pathways mediated by stress hormones and cytokines cause a catabolic state. The loss of body cell mass may result in prolonged convalescence and increased morbidity. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Diabetes Mellitus Type 2, Insulin Resistance
- What is being tested?
- Intensified insulin therapy
- Type of treatment
- Injection or infusion, Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 18 participants
- Where
- No sites listed yet
- Study dates
- Dec 2009to Nov 2010
- Phase
- Interventional
- 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
Who may be able to join
- Patients undergoing elective colorectal surgery for non-metastatic disease
- Type 2 diabetes mellitus with plasma level of glycosylated hemoglobin level (HbA(1c)) less than 10% indicating normal or moderate glycemic control
- Being capable of signing informed consent
- Accepting an epidural catheter for perioperative analgesia
Who cannot join
- American Society of Anesthesiologists (ASA) Physical Status classification system 4 with major cardiac disorders (severe arrhythmias, recent myocardial ischemia (MI), heart failure, uncontrolled hypertension)
- Hepatic disorders (liver failure, jaundice, metastatic disease), renal disorders (acute or chronic renal failure or on dialysis)
- Metabolic disorders (untreated hyperthyroidism, pyrexia, more than 10% weight loss over the preceding three months, plasma albumin concentration < 35g/l)
- Anemia (hemoglobin < 10 g/dl)
- Chemotherapy or radiotherapy during six months before surgery
- Inflammatory bowel disease or other inflammatory condition
- Pregnancy
- Previous spine surgery precluding placement of an epidural catheter.
About this study
Background Surgical injury provokes a stress response. These pathways mediated by stress hormones and cytokines cause a catabolic state. The loss of body cell mass may result in prolonged convalescence and increased morbidity. Protein catabolism after colorectal surgery is even more increased in patients with type 2 diabetes mellitus. Epidural blockade, by reducing the intensity of the catabolic response, improves substrate utilization after surgery in non-diabetic patients. This effect is even more pronounced in diabetic patients receiving amino acids.
The aim of the study is to explore the effect of two different protocols to manage blood glucose control on glucose and protein metabolism in patients with type 2 diabetes mellitus undergoing colon surgery and receiving epidural analgesia and perioperative feeding with amino acids. The following hypotheses are tested:
Read more
- Tight perioperative blood glucose control with intensified insulin therapy compared to standard blood glucose control in presence of general anesthesia with epidural analgesia and amino acid infusion would reduce endogenous glucose production and leucine oxidation.
- Tight blood glucose control and perioperative infusion of amino acids induce a more positive protein balance compared to standard blood glucose control by better oxidative glucose utilization and redirecting amino acids from oxidative to synthetic pathways.
Material and Methods A total of 20 patients with diabetes mellitus type 2 undergoing elective colorectal surgery will be admitted to the study. Patients will be randomly assigned to receive standard blood glucose control (blood glucose target <10 mmol*l-1; control group; cytotoxic T lymphocyte (CTL) group, n=8) or to receive tight blood glucose control with intensified insulin therapy (blood glucose target<6 mmol*l-1; intensified insulin group; II group, n=8). All patients will receive general anesthesia and an epidural catheter for perioperative analgesia. During surgery (intraoperative state) and immediately after surgery (postoperative state) when receiving an amino acid infusion protein and glucose kinetics will be assessed using a stable isotope technique with L-[1-13C]leucine and [6,6-2H2]glucose and circulating concentrations of glucose, glucagon, insulin and cortisol will be measured. The primary endpoints of the study will be protein balance. Sample size is set to ensure at least 80% power at a significance level of 0.05.
Read the detailed description
see information below
- Conditions
- Diabetes Mellitus Type 2, Insulin Resistance
- Being tested
- Intensified insulin therapy
- Medical subject headings
- Diabetes Mellitus, Type 2, Insulin Resistance
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Intensified insulin therapyProcedure or surgery
Also called continuous insulin infusion
| Study group | Role | What they receive |
|---|---|---|
| Intensified insulin group | Experimental | Patients undergoing elective colorectal surgery will receive standard anesthesia including epidural analgesia and nutritional support with an intravenous amino acid solution while receiving tight blood glucose control with intensified insulin therapy (blood glucose target<6 mmol*l-1) via an continuous insulin infusion. Receives: Procedure: Intensified insulin therapy |
| Control group | No intervention | Patients undergoing elective colorectal surgery will receive standard anesthesia including epidural analgesia and nutritional support with an intravenous amino acid solution while receiving standard blood glucose control (blood glucose target <10 mmol*l-1) via subcutaneous insulin boluses |
What is being measured
The primary outcome is the main question the study is designed to answer.
Postoperative protein balance (leucine) (umol/kg/h)
Measured and calculated with a 3-hour stable isotope tracer technique with L-(1-13C)leucine and calorimetry towards the end of the 3 hour period
Measured: Postoperative period: starting with arrival in the postoperative care unit and ending after 3 hours
Secondary outcomes (10)
Intraoperative protein metabolism: Rate of appearance of leucine (umol/kg/h)
Measured and calculated with a 3-hour stable isotope tracer technique with L-(1-13C)leucine
Measured: Intraoperative period: starting with the induction of anesthesia and ending after 3 hours (during surgery)
Intraoperative protein metabolism: endogenous rate of appearance of leucine (umol/kg/h)
Measured and calculated with a 3-hour stable isotope tracer technique with L-(1-13C)leucine
Measured: Intraoperative period: starting with the induction of anesthesia and ending after 3 hours (during surgery)
Intraoperative glucose metabolism: Endogenous rate of appearance of glucose (umol/kg/min)
Measured and calculated with a 3-hour stable isotope tracer technique with D-(6,6-2H2)glucose
Measured: Intraoperative period: starting with the induction of anesthesia and ending after 3 hours (during surgery)
Intraoperative glucose metabolism: Glucose clearance (ml/kg/min)
Measured and calculated with a 3-hour stable isotope tracer technique with D-(6,6-2H2)glucose and plasma glucose measurement
Measured: Intraoperative period: starting with the induction of anesthesia and ending after 3 hours (during surgery)
Postoperative protein metabolism: Rate of appearance of leucine (umol/kg/h)
Measured and calculated with a 3-hour stable isotope tracer technique with L-(1-13C)leucine and calorimetry towards the end of the 3 hour period
Measured: Postoperative period: starting with arrival in the postoperative care unit and ending after 3 hours
Postoperative protein metabolism: Endogenous rate of appearance of leucine (umol/kg/h)
Measured and calculated with a 3-hour stable isotope tracer technique with L-(1-13C)leucine and calorimetry towards the end of the 3 hour period
Measured: Postoperative period: starting with arrival in the postoperative care unit and ending after 3 hours
Postoperative protein metabolism: Leucine oxidation (umol/kg/h)
Measured and calculated with a 3-hour stable isotope tracer technique with L-(1-13C)leucine and calorimetry towards the end of the 3 hour period
Measured: Postoperative period: starting with arrival in the postoperative care unit and ending after 3 hours
Postoperative protein metabolism: Protein synthesis (leucine) (umol/kg/h)
Measured and calculated with a 3-hour stable isotope tracer technique with L-(1-13C)leucine and calorimetry towards the end of the 3 hour period
Measured: Postoperative period: starting with arrival in the postoperative care unit and ending after 3 hours
Postoperative glucose metabolism: Endogenous rate of appearance of glucose (umol/kg/min)
Measured and calculated with a 3-hour stable isotope tracer technique with D-(6,6-2H2)glucose
Measured: Postoperative period: starting with arrival in the postoperative care unit and ending after 3 hours
Postoperative glucose metabolism: Glucose clearance (ml/kg/min)
Measured and calculated with a 3-hour stable isotope tracer technique with D-(6,6-2H2)glucose and plasma glucose measurement
Measured: Postoperative period: starting with arrival in the postoperative care unit and ending after 3 hours
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted11 Aug 2016 (estimated)
- Study startDec 2009
- Primary completionNov 2010
- Study completionNov 2010
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Diabetes Mellitus Type 2Studies of the same condition, open and under way.
- More trials run by University Hospital, Basel, SwitzerlandThe 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 N/A
- Primary purpose
- Basic science
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 18 participants (actual)
Sponsor and investigators
- Lead sponsor
- University Hospital, Basel, Switzerland
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Andrea Kopp Lugli, MD, MSc, Study chair, University Hospital, Basel, Switzerland
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02863276
- Sponsor's protocol ID
- 230/09
- Status last verified
- Aug 2016
- First submitted
- 8 Aug 2016
- Last updated
- 11 Aug 2016
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 11 Aug 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Modulating the Stress Response in Diabetes Mellitus Type 2 Patients Undergoing Colon Surgery
- ClinicalTrials.gov ID
- NCT02863276
- Acronym / sponsor ID
- 230/09
- Conditions
- Diabetes Mellitus Type 2, Insulin Resistance
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 18 participants (actual)
- Lead sponsor
- University Hospital, Basel, SwitzerlandUniversity, hospital or other
- Study start
- Dec 2009
- Primary completion
- Nov 2010 (actual)
- Study completion
- Nov 2010 (actual)
- First posted
- 11 Aug 2016 (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 Surgical injury provokes a stress response. These pathways mediated by stress hormones and cytokines cause a catabolic state. The loss of body cell mass may result in prolonged convalescence and increased morbidity. Protein catabolism after colorectal surgery is even more increased in patients with type 2 diabetes mellitus. Epidural blockade, by reducing the intensity of the catabolic response, improves substrate utilization after surgery in non-diabetic patients. This effect is even more pronounced in diabetic patients receiving amino acids.
The aim of the study is to explore the effect of two different protocols to manage blood glucose control on glucose and protein metabolism in patients with type 2 diabetes mellitus undergoing colon surgery and receiving epidural analgesia and perioperative feeding with amino acids. The following hypotheses are tested:
- Tight perioperative blood glucose control with intensified insulin therapy compared to standard blood glucose control in presence of general anesthesia with epidural analgesia and amino acid infusion would reduce endogenous glucose production and leucine oxidation.
- Tight blood glucose control and perioperative infusion of amino acids induce a more positive protein balance compared to standard blood glucose control by better oxidative glucose utilization and redirecting amino acids from oxidative to synthetic pathways.
Material and Methods A total of 20 patients with diabetes mellitus type 2 undergoing elective colorectal surgery will be admitted to the study. Patients will be randomly assigned to receive standard blood glucose control (blood glucose target <10 mmol*l-1; control group; cytotoxic T lymphocyte (CTL) group, n=8) or to receive tight blood glucose control with intensified insulin therapy (blood glucose target<6 mmol*l-1; intensified insulin group; II group, n=8). All patients will receive general anesthesia and an epidural catheter for perioperative analgesia. During surgery (intraoperative state) and immediately after surgery (postoperative state) when receiving an amino acid infusion protein and glucose kinetics will be assessed using a stable isotope technique with L-[1-13C]leucine and [6,6-2H2]glucose and circulating concentrations of glucose, glucagon, insulin and cortisol will be measured. The primary endpoints of the study will be protein balance. Sample size is set to ensure at least 80% power at a significance level of 0.05.
Detailed description
see information below
Study design
- Primary purpose
- Basic science
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Intensified insulin group | Experimental | Procedure: Intensified insulin therapyPatients undergoing elective colorectal surgery will receive standard anesthesia including epidural analgesia and nutritional support with an intravenous amino acid solution while receiving tight blood glucose control with intensified insulin therapy (blood glucose target<6 mmol*l-1) via an continuous insulin infusion. |
| Control group | No intervention | –Patients undergoing elective colorectal surgery will receive standard anesthesia including epidural analgesia and nutritional support with an intravenous amino acid solution while receiving standard blood glucose control (blood glucose target <10 mmol*l-1) via subcutaneous insulin boluses |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- Patients undergoing elective colorectal surgery for non-metastatic disease
- Type 2 diabetes mellitus with plasma level of glycosylated hemoglobin level (HbA(1c)) less than 10% indicating normal or moderate glycemic control
- Being capable of signing informed consent
- Accepting an epidural catheter for perioperative analgesia
Key exclusion criteria (8 listed)
- American Society of Anesthesiologists (ASA) Physical Status classification system 4 with major cardiac disorders (severe arrhythmias, recent myocardial ischemia (MI), heart failure, uncontrolled hypertension)
- Hepatic disorders (liver failure, jaundice, metastatic disease), renal disorders (acute or chronic renal failure or on dialysis)
- Metabolic disorders (untreated hyperthyroidism, pyrexia, more than 10% weight loss over the preceding three months, plasma albumin concentration < 35g/l)
- Anemia (hemoglobin < 10 g/dl)
- Chemotherapy or radiotherapy during six months before surgery
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 |
|---|---|---|
| Intensified insulin therapyAlso: continuous insulin infusion | Procedure or surgery | Intensified insulin group |
Primary outcome
Postoperative protein balance (leucine) (umol/kg/h)
Time frame: Postoperative period: starting with arrival in the postoperative care unit and ending after 3 hours
Measured and calculated with a 3-hour stable isotope tracer technique with L-(1-13C)leucine and calorimetry towards the end of the 3 hour period
10 secondary outcomes
Intraoperative protein metabolism: Rate of appearance of leucine (umol/kg/h)
Time frame: Intraoperative period: starting with the induction of anesthesia and ending after 3 hours (during surgery)
Intraoperative protein metabolism: endogenous rate of appearance of leucine (umol/kg/h)
Time frame: Intraoperative period: starting with the induction of anesthesia and ending after 3 hours (during surgery)
Intraoperative glucose metabolism: Endogenous rate of appearance of glucose (umol/kg/min)
Time frame: Intraoperative period: starting with the induction of anesthesia and ending after 3 hours (during surgery)
Intraoperative glucose metabolism: Glucose clearance (ml/kg/min)
Time frame: Intraoperative period: starting with the induction of anesthesia and ending after 3 hours (during surgery)
Postoperative protein metabolism: Rate of appearance of leucine (umol/kg/h)
Time frame: Postoperative period: starting with arrival in the postoperative care unit and ending after 3 hours
Postoperative protein metabolism: Endogenous rate of appearance of leucine (umol/kg/h)
Time frame: Postoperative period: starting with arrival in the postoperative care unit and ending after 3 hours
Postoperative protein metabolism: Leucine oxidation (umol/kg/h)
Time frame: Postoperative period: starting with arrival in the postoperative care unit and ending after 3 hours
Postoperative protein metabolism: Protein synthesis (leucine) (umol/kg/h)
Time frame: Postoperative period: starting with arrival in the postoperative care unit and ending after 3 hours
Postoperative glucose metabolism: Endogenous rate of appearance of glucose (umol/kg/min)
Time frame: Postoperative period: starting with arrival in the postoperative care unit and ending after 3 hours
Postoperative glucose metabolism: Glucose clearance (ml/kg/min)
Time frame: Postoperative period: starting with arrival in the postoperative care unit and ending after 3 hours
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 11 Aug 2016.
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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.
Andrea Kopp Lugli, MD, MSc study chair
University Hospital, Basel, Switzerland
Questions about this trial
What is this clinical trial studying?
A study testing Intensified insulin therapy in people with Diabetes Mellitus Type 2 and Insulin Resistance, run by University Hospital, Basel, Switzerland.
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 4 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: finished, as of the sponsor's last update on 11 Aug 2016. Status can change between updates, so confirm with the study contact before making plans.
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 protein balance (leucine) (umol/kg/h) (time frame: Postoperative period: starting with arrival in the postoperative care unit and ending after 3 hours). 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 11 Aug 2016.