Diabetes MellitusIINDUNCT00700154
Insulin Infusion Diabetes Ulcer
A study testing Insulin infusion in people with Diabetes Mellitus and Insulin Resistance, run by Karolinska Institutet at 1 site in Sweden.
Trial summary
Normoglycemia is important for the outcome of surgical and medical conditions. Insulin infusions have been studied to achieve normoglycemia during these circumstances and have proved to be useful. Read more about this study
- Who is it for?
- Ages 18 to 99 years
- Conditions the study is for
- Diabetes Mellitus, Insulin Resistance, Hyperglycemia
- What is being tested?
- Insulin infusion
- Type of treatment
- Injection or infusion, Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 40 participants
- Where
- 1 siteSweden
- Study dates
- Nov 2011to 21 Dec 2020
- 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 to 99 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Patients are eligible for inclusion if the following criteria are fulfilled:
- Patients with diabetes type 1 or type 2.
- Older than 18 years.
- Patients scheduled for cardio- vascular surgery and/ or acute ulcer infection.
- Hyperglycaemia: Capillary P-glucose above 8 mmol/L.
- Informed consent obtained.
Who cannot join
- Patients having any of the following at randomization will not be included in the study:
- Unconsciousness: not possible to wake up.
- Ketoacidosis: pH less or equal to 7.30.
- Hyperosmolar syndrome: S-Na more or equal to 150 mmol/L.
- Kidney failure: calculated GFR < 30 mL/min.
- Pregnancy.
- Mental condition making the subject unable to understand the concepts and risk of the study
Trial locations and contacts
1 site in 1 country.
Sweden1 site
Department of Vascular Surgery, Karolinska University Hospital
Stockholm, SE-171 76
About this study
Official title: The Effect of Insulin Infusion on Metabolic Control and Inflammation in Diabetic Patients During Cardio-vascular Intervention and/or Treatment for Acute Foot Ulcer Infection.
Normoglycemia is important for the outcome of surgical and medical conditions. Insulin infusions have been studied to achieve normoglycemia during these circumstances and have proved to be useful. Insulin given by subcutaneous injections has longer duration compared to intravenous given insulin which makes it more difficult to control. The hypothesis behind the trial is the concept that insulin infusion is more effective in reaching normoglycemia in diabetic subjects during treatment for ulcer infections and/or planned cardio-vascular surgery.
- The study evaluates a target controlled insulin infusion or conventional therapy as antidiabetic treatment during ulcer infection and after cardio- vascular surgery.
- Secondary efficacy parameter will be hospital stay, laboratories for inflammation and oxidative stress.
Read the detailed description
Introduction:
Normoglycemia is important for the outcome of acute surgical and medical conditions. Different insulin infusions have been studied to achieve normoglycemia and have proved to be useful. Insulin given by subcutaneous injections has duration between 3- 36 hours depending on the insulin brand and injection site compared to 10 minutes for intravenous given insulin. Different insulin infusions have been studied to achieve normoglycemia but the biological and chemical effects of insulin infusions have not been studied in routine operative care of patients with diabetes. Therefore, we aim to investigate the importance of normoglycemia for the optimal treatment of ulcer infection and/ or during routine cardio- vascular surgery care among diabetics.
Hypothesis:
Target controlled insulin infusion is more effective in reducing hyperglycemia, improve healing of inflammation and infection in diabetics compared to conventional antidiabetic therapy.
The infusion starts when patients who met the eligibility criteria has signed the informed consent. The intervention group continues for tree full days with insulin infusion. After the transition day (the fourth day) multiple doses of mixinsulin continues until the study ends 4 weeks after the randomization.
Study Design:
This is a randomized prospective, open controlled trial of target controlled insulin infusion vs conventional antidiabetic therapy in diabetic patients. Diabetics planned treated for ulcer infection and/ or after elective cardio- vascular surgery, who met inclusion, not exclusion criteria and choose to participate will be included and randomized.
Duration of study:
The infusion starts when patients who met the eligibility criteria have signed the informed consent and for the surgery group prior the surgery the operation day for all patients and stops during the postoperative care in the control group (conventional therapy). The intervention group continues for three full days with insulin infusion. After the transition day (the fourth day) multiple doses of mixinsulin continues until the study ends 4 weeks after the randomization.
Selection of patients:
Patients with diabetic ulcer infection and/or planned cardio-vascular intervention will be enrolled.
Treatment:
Eligible patients will be randomized to insulin infusion (group 1) for 3 days or therapy according to clinical practise (group 2).
Group 1 (intervention group):
The insulin infusion starts when the patients full fill the eligibility criteria, has signed the informed consent and for the surgery group prior the start of the operation. It controls by regular capillary plasma glucose tests and continues for three days. The infusion stop on the fourth day, the insulin demand is estimated from the last 24 infusion hours by a specific algorithm and divided to 2-4 equal mealtime doses of mixinsulin. The first mealtime dose is given to the breakfast on the fourth day and the infusion continues for another 2 hours where after it is stopped. After the transition day (the fourth day) multiple doses of mixinsulin continues until the study ends 4 weeks after the randomization.
All patients will have a stop visit at the study end.
- Conditions
- Diabetes Mellitus, Insulin Resistance, Hyperglycemia, Surgery, Ulcers, Infection
- Being tested
- Insulin infusion
- Keywords
- Vascular Surgery, Complications, Hyperglycemia, Insulin infusion, Diabetic ulcers, Infection
- Medical subject headings
- Diabetes Mellitus, Insulin Resistance, Hyperglycemia, Ulcer, Infections
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Insulin infusionProcedure or surgery
Also called Insulin aspart: NovoRapid
The infusion, a fast acting insulin analog in 1 Unit/ml of NaCl, starts prior the surgery the operation day for all patients and stops during the postoperative care in the control group (conventional therapy), the intervention group continues for three full days with insulin infusion. After the transition day (the fourth day) multiple doses of mixinsulin continues until the study ends 4 weeks after the randomization.
| Study group | Role | What they receive |
|---|---|---|
| Insulin infusion (aspart) | Experimental | Not described Receives: Procedure: Insulin infusion |
| Standard care | No intervention | Glucose control according to standard care at the ward, i.e., sliding scale insulin at the discretion of responsible physician. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Plasma glucose levels
Measured: 4 weeks
Secondary outcomes (3)
Hospital stay
Measured: 4 weeks
HbA1c
Measured: 4 weeks
laboratories for inflammation and oxidative stress
Measured: 4 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted18 Jun 2008 (estimated)
- Study startNov 2011
- Primary completion21 Dec 2020
- Study completion21 Dec 2020
Why it stopped: participants are no longer being examined or receiving intervention
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (23)Papers the sponsor has linked to this study.
- Other trials for Diabetes MellitusStudies of the same condition, open and under way.
- More trials run by Karolinska InstitutetThe 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
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 40 participants (actual)
Sponsor and investigators
- Lead sponsor
- Karolinska Institutet
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Mats Bonnier, Karolinska Institutet
- Investigators
- Kerstin Brismar, Professor, Study director, Karolinska InstitutetMats Bonnier, M.D, Principal investigator, Karolinska Institutet
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00700154
- Sponsor's protocol ID
- IICVS_00
- Acronym
- IINDU
- Status last verified
- Dec 2020
- First submitted
- 9 Jun 2008
- Last updated
- 23 Dec 2020
- Results posted
- No
- Data monitoring committee
- Yes
Publications
Malmstedt J, Wahlberg E, Jorneskog G, Swedenborg J. Influence of perioperative blood glucose levels on outcome after infrainguinal bypass surgery in patients with diabetes. Br J Surg. 2006 Nov;93(11):1360-7. doi: 10.1002/bjs.5466.
PubMed 16779879Bonnier M, Lonnroth P, Gudbjornsdottir S, Attvall S, Jansson PA. Validation of a glucose-insulin-potassium infusion algorithm in hospitalized diabetic patients. J Intern Med. 2003 Feb;253(2):189-93. doi: 10.1046/j.1365-2796.2003.01085.x.
PubMed 12542559Van den Berghe G, Wilmer A, Milants I, Wouters PJ, Bouckaert B, Bruyninckx F, Bouillon R, Schetz M. Intensive insulin therapy in mixed medical/surgical intensive care units: benefit versus harm. Diabetes. 2006 Nov;55(11):3151-9. doi: 10.2337/db06-0855.
PubMed 17065355Bastard JP, Maachi M, Lagathu C, Kim MJ, Caron M, Vidal H, Capeau J, Feve B. Recent advances in the relationship between obesity, inflammation, and insulin resistance. Eur Cytokine Netw. 2006 Mar;17(1):4-12.
PubMed 16613757Brismar K, Fernqvist-Forbes E, Wahren J, Hall K. Effect of insulin on the hepatic production of insulin-like growth factor-binding protein-1 (IGFBP-1), IGFBP-3, and IGF-I in insulin-dependent diabetes. J Clin Endocrinol Metab. 1994 Sep;79(3):872-8. doi: 10.1210/jcem.79.3.7521354.
PubMed 7521354Hadi HA, Suwaidi JA. Endothelial dysfunction in diabetes mellitus. Vasc Health Risk Manag. 2007;3(6):853-76.
PubMed 18200806Abourizk NN, Vora CK, Verma PK. Inpatient diabetology. The new frontier. J Gen Intern Med. 2004 May;19(5 Pt 1):466-71. doi: 10.1111/j.1525-1497.2004.30133.x.
PubMed 15109346Collier B, Dossett LA, May AK, Diaz JJ. Glucose control and the inflammatory response. Nutr Clin Pract. 2008 Feb;23(1):3-15. doi: 10.1177/011542650802300103.
PubMed 18203960Griesdale DE, de Souza RJ, van Dam RM, Heyland DK, Cook DJ, Malhotra A, Dhaliwal R, Henderson WR, Chittock DR, Finfer S, Talmor D. Intensive insulin therapy and mortality among critically ill patients: a meta-analysis including NICE-SUGAR study data. CMAJ. 2009 Apr 14;180(8):821-7. doi: 10.1503/cmaj.090206. Epub 2009 Mar 24.
PubMed 19318387Sjoholm A, Nystrom T. Inflammation and the etiology of type 2 diabetes. Diabetes Metab Res Rev. 2006 Jan-Feb;22(1):4-10. doi: 10.1002/dmrr.568.
PubMed 15991254Sjoholm A, Nystrom T. Endothelial inflammation in insulin resistance. Lancet. 2005 Feb 12-18;365(9459):610-2. doi: 10.1016/S0140-6736(05)17912-4.
PubMed 15708106Campbell RK. Etiology and effect on outcomes of hyperglycemia in hospitalized patients. Am J Health Syst Pharm. 2007 May 15;64(10 Suppl 6):S4-8. doi: 10.2146/ajhp070100.
PubMed 17494892Van den Berghe G, Schetz M, Vlasselaers D, Hermans G, Wilmer A, Bouillon R, Mesotten D. Clinical review: Intensive insulin therapy in critically ill patients: NICE-SUGAR or Leuven blood glucose target? J Clin Endocrinol Metab. 2009 Sep;94(9):3163-70. doi: 10.1210/jc.2009-0663. Epub 2009 Jun 16.
PubMed 19531590Kotronen A, Lewitt M, Hall K, Brismar K, Yki-Jarvinen H. Insulin-like growth factor binding protein 1 as a novel specific marker of hepatic insulin sensitivity. J Clin Endocrinol Metab. 2008 Dec;93(12):4867-72. doi: 10.1210/jc.2008-1245. Epub 2008 Sep 16.
PubMed 18796514King GL. The role of inflammatory cytokines in diabetes and its complications. J Periodontol. 2008 Aug;79(8 Suppl):1527-34. doi: 10.1902/jop.2008.080246.
PubMed 18673007
Study at a glance
From the registry record, last updated by the sponsor on 23 Dec 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Effect of Insulin Infusion on Metabolic Control and Inflammation in Diabetic Patients During Cardio-vascular Intervention and/or Treatment for Acute Foot Ulcer Infection.
- ClinicalTrials.gov ID
- NCT00700154
- Acronym / sponsor ID
- IINDU / IICVS_00
- Conditions
- Diabetes Mellitus, Insulin Resistance, Hyperglycemia, Surgery, Ulcers, Infection
- Keywords
- Vascular Surgery, Complications, Hyperglycemia, Insulin infusion, Diabetic ulcers, Infection
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: participants are no longer being examined or receiving intervention
- Enrolment
- 40 participants (actual)
- Lead sponsor
- Karolinska InstitutetUniversity, hospital or other
- Study start
- Nov 2011 (actual)
- Primary completion
- 21 Dec 2020 (actual)
- Study completion
- 21 Dec 2020 (actual)
- First posted
- 18 Jun 2008 (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.
Normoglycemia is important for the outcome of surgical and medical conditions. Insulin infusions have been studied to achieve normoglycemia during these circumstances and have proved to be useful. Insulin given by subcutaneous injections has longer duration compared to intravenous given insulin which makes it more difficult to control. The hypothesis behind the trial is the concept that insulin infusion is more effective in reaching normoglycemia in diabetic subjects during treatment for ulcer infections and/or planned cardio-vascular surgery.
- The study evaluates a target controlled insulin infusion or conventional therapy as antidiabetic treatment during ulcer infection and after cardio- vascular surgery.
- Secondary efficacy parameter will be hospital stay, laboratories for inflammation and oxidative stress.
Detailed description
Introduction:
Normoglycemia is important for the outcome of acute surgical and medical conditions. Different insulin infusions have been studied to achieve normoglycemia and have proved to be useful. Insulin given by subcutaneous injections has duration between 3- 36 hours depending on the insulin brand and injection site compared to 10 minutes for intravenous given insulin. Different insulin infusions have been studied to achieve normoglycemia but the biological and chemical effects of insulin infusions have not been studied in routine operative care of patients with diabetes. Therefore, we aim to investigate the importance of normoglycemia for the optimal treatment of ulcer infection and/ or during routine cardio- vascular surgery care among diabetics.
Hypothesis:
Target controlled insulin infusion is more effective in reducing hyperglycemia, improve healing of inflammation and infection in diabetics compared to conventional antidiabetic therapy.
The infusion starts when patients who met the eligibility criteria has signed the informed consent. The intervention group continues for tree full days with insulin infusion. After the transition day (the fourth day) multiple doses of mixinsulin continues until the study ends 4 weeks after the randomization.
Study Design:
This is a randomized prospective, open controlled trial of target controlled insulin infusion vs conventional antidiabetic therapy in diabetic patients. Diabetics planned treated for ulcer infection and/ or after elective cardio- vascular surgery, who met inclusion, not exclusion criteria and choose to participate will be included and randomized.
Duration of study:
The infusion starts when patients who met the eligibility criteria have signed the informed consent and for the surgery group prior the surgery the operation day for all patients and stops during the postoperative care in the control group (conventional therapy). The intervention group continues for three full days with insulin infusion. After the transition day (the fourth day) multiple doses of mixinsulin continues until the study ends 4 weeks after the randomization.
Selection of patients:
Patients with diabetic ulcer infection and/or planned cardio-vascular intervention will be enrolled.
Treatment:
Eligible patients will be randomized to insulin infusion (group 1) for 3 days or therapy according to clinical practise (group 2).
Group 1 (intervention group):
The insulin infusion starts when the patients full fill the eligibility criteria, has signed the informed consent and for the surgery group prior the start of the operation. It controls by regular capillary plasma glucose tests and continues for three days. The infusion stop on the fourth day, the insulin demand is estimated from the last 24 infusion hours by a specific algorithm and divided to 2-4 equal mealtime doses of mixinsulin. The first mealtime dose is given to the breakfast on the fourth day and the infusion continues for another 2 hours where after it is stopped. After the transition day (the fourth day) multiple doses of mixinsulin continues until the study ends 4 weeks after the randomization.
All patients will have a stop visit at the study end.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Insulin infusion (aspart) | Experimental | Procedure: Insulin infusion |
| Standard care | No intervention | –Glucose control according to standard care at the ward, i.e., sliding scale insulin at the discretion of responsible physician. |
Who may qualify
- Ages
- 18 to 99 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- Patients are eligible for inclusion if the following criteria are fulfilled:
Key exclusion criteria (7 listed)
- Patients having any of the following at randomization will not be included in the study:
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 |
|---|---|---|
| Insulin infusionAlso: Insulin aspart: NovoRapidThe infusion, a fast acting insulin analog in 1 Unit/ml of NaCl, starts prior the surgery the operation day for all patients and stops during the postoperative care in the control group (conventional therapy), the intervention group continues for three full days with insulin infusion. After the transition day (the fourth day) multiple doses of mixinsulin continues until the study ends 4 weeks after the randomization. | Procedure or surgery | Insulin infusion (aspart) |
Primary outcome
Plasma glucose levels
Time frame: 4 weeks
3 secondary outcomes
Hospital stay
Time frame: 4 weeks
HbA1c
Time frame: 4 weeks
laboratories for inflammation and oxidative stress
Time frame: 4 weeks
Results and safety
The study was stopped early (reason given: participants are no longer being examined or receiving intervention). Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 23 Dec 2020.
- Background: PubMed 16779879Malmstedt J, Wahlberg E, Jorneskog G, Swedenborg J. Influence of perioperative blood glucose levels on outcome after infrainguinal bypass surgery in patients with diabetes. Br J Surg. 2006 Nov;93(11):1360-7. doi: 10.1002/bjs.5466.
- Background: PubMed 12542559Bonnier M, Lonnroth P, Gudbjornsdottir S, Attvall S, Jansson PA. Validation of a glucose-insulin-potassium infusion algorithm in hospitalized diabetic patients. J Intern Med. 2003 Feb;253(2):189-93. doi: 10.1046/j.1365-2796.2003.01085.x.
- Background: PubMed 17065355Van den Berghe G, Wilmer A, Milants I, Wouters PJ, Bouckaert B, Bruyninckx F, Bouillon R, Schetz M. Intensive insulin therapy in mixed medical/surgical intensive care units: benefit versus harm. Diabetes. 2006 Nov;55(11):3151-9. doi: 10.2337/db06-0855.
- Background: PubMed 16613757Bastard JP, Maachi M, Lagathu C, Kim MJ, Caron M, Vidal H, Capeau J, Feve B. Recent advances in the relationship between obesity, inflammation, and insulin resistance. Eur Cytokine Netw. 2006 Mar;17(1):4-12.
- Background: PubMed 7521354Brismar K, Fernqvist-Forbes E, Wahren J, Hall K. Effect of insulin on the hepatic production of insulin-like growth factor-binding protein-1 (IGFBP-1), IGFBP-3, and IGF-I in insulin-dependent diabetes. J Clin Endocrinol Metab. 1994 Sep;79(3):872-8. doi: 10.1210/jcem.79.3.7521354.
- Background: PubMed 18200806Hadi HA, Suwaidi JA. Endothelial dysfunction in diabetes mellitus. Vasc Health Risk Manag. 2007;3(6):853-76.
- Background: PubMed 15109346Abourizk NN, Vora CK, Verma PK. Inpatient diabetology. The new frontier. J Gen Intern Med. 2004 May;19(5 Pt 1):466-71. doi: 10.1111/j.1525-1497.2004.30133.x.
- Background: PubMed 18203960Collier B, Dossett LA, May AK, Diaz JJ. Glucose control and the inflammatory response. Nutr Clin Pract. 2008 Feb;23(1):3-15. doi: 10.1177/011542650802300103.
- Background: PubMed 19318387Griesdale DE, de Souza RJ, van Dam RM, Heyland DK, Cook DJ, Malhotra A, Dhaliwal R, Henderson WR, Chittock DR, Finfer S, Talmor D. Intensive insulin therapy and mortality among critically ill patients: a meta-analysis including NICE-SUGAR study data. CMAJ. 2009 Apr 14;180(8):821-7. doi: 10.1503/cmaj.090206. Epub 2009 Mar 24.
- Background: PubMed 15991254Sjoholm A, Nystrom T. Inflammation and the etiology of type 2 diabetes. Diabetes Metab Res Rev. 2006 Jan-Feb;22(1):4-10. doi: 10.1002/dmrr.568.
- Background: PubMed 15708106Sjoholm A, Nystrom T. Endothelial inflammation in insulin resistance. Lancet. 2005 Feb 12-18;365(9459):610-2. doi: 10.1016/S0140-6736(05)17912-4.
- Background: PubMed 17494892Campbell RK. Etiology and effect on outcomes of hyperglycemia in hospitalized patients. Am J Health Syst Pharm. 2007 May 15;64(10 Suppl 6):S4-8. doi: 10.2146/ajhp070100.
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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.
Kerstin Brismar, Professor study director
Karolinska Institutet
Mats Bonnier, M.D principal investigator
Karolinska Institutet
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Insulin infusion in people with Diabetes Mellitus and Insulin Resistance, run by Karolinska Institutet at 1 site in Sweden.
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 6 inclusion and 7 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: stopped early, as of the sponsor's last update on 23 Dec 2020. 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 Sweden. 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 was stopped early (reason given: participants are no longer being examined or receiving intervention). Results are not available in the source record.
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?
Plasma glucose levels (time frame: 4 weeks). 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 NCT00700154, which also lists 23 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 23 Dec 2020.