DiabetesUSCDPNCT00646438
United States Coronary Artery Bypass Surgery (CABG) Diabetes Project (USCDP) Pilot Study
A study of Diabetes and Coronary Artery Disease, run by Providence Heart & Vascular Institute at 1 site in United States.
Trial summary
Standard care for patients with diabetes having CABG surgery at Providence St. Vincent Medical Center includes strict control of blood sugar (glucose) levels for 3 days after surgery. Read more about this study
- Who is it for?
- Ages 18 to 80 years
- Conditions the study is for
- Diabetes, Coronary Artery Disease
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 120 participants
- Where
- 1 siteUnited States
- Study dates
- Mar 2009to Dec 2012
- 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 80 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Patients 18 - 80 years old
- Pre-op diagnosis of diabetes
- Scheduled for elective or urgent CABG surgery
- Able to sign informed consent for research study
Who cannot join
- Patients less than 18 years old or greater than 80 years old
- Emergent or salvage CABG surgery
- Other surgical intervention planned in same setting ( Valve surgery, TMR, MAZE...)
Trial locations and contacts
1 site in 1 country.
United States1 site
Providence St. Vincent Medical Center
Portland, Oregon, 97225
Eric M. Johnson, BA/CCRC, 503-216-2075, eric.johnson@providence.org
Tony Furnary, MD, 503-297-1419, tfurnary@mac.com
About this study
Official title: United States CABG Diabetes Project (USCDP) Pilot Study
Standard care for patients with diabetes having CABG surgery at Providence St. Vincent Medical Center includes strict control of blood sugar (glucose) levels for 3 days after surgery. This is done through frequent monitoring of blood sugar levels and by giving insulin continuously through a needle into a vein (intravenously). This intensive glucose control has resulted in fewer complications such as serious infections and death, and has shortened the length of the hospital stay for patients.
This study treatment is different from standard treatment in that it extends the intensive glucose control beyond the third postoperative day to one full year. Once discharged from the hospital following the CABG procedure, the intense glucose control is done using subcutaneous insulin (a shot under the skin), oral medications, and by measuring blood sugar levels frequently.
The purpose of this study is to see how safe and effective strict glucose control is when extended beyond 3 days and hospital discharge for one year. Another purpose is to see how well patients can comply with the daily management of intensive glucose control for one-year as well as the study follow-up schedule.
Read the detailed description
Purpose Pilot study to gather information for "United States CABG Diabetes Project" (USCDP) Multi-center Randomized Trial.
For 14 years our research team has successfully implemented an increasingly aggressive series of intravenous insulin protocols that normalize blood glucose levels for 3 postoperative days in patients with diabetes who undergo cardiac surgery. This has resulted in significant reductions in mortality, infection and length of stay (LOS) and has normalized those outcomes to those of the population without diabetes (DM). The current protocol ends on the morning of the 3rd postoperative day.
We believe that a logical expansion of this groundbreaking work is to extend the duration of intensive glycemic control beyond the third postoperative day and into the outpatient period. However it would be impossible to do so with the continued use of CII therapy. Therefore, we propose to employ intensive subcutaneous insulin therapies and oral hypoglycemic agents to affect continued tight glycemic control following discontinuation of CII and continue such therapy beyond hospital discharge for a period of at least one year.
We hypothesize that this will lead to further reductions in major adverse cardiac outcomes in the high-risk diabetes coronary artery bypass grafts (CABG) subgroup. The optimal method to test this hypothesis is with a very large, multi-center clinical trial. However, before embarking on such a resource-consuming endeavor, we intend to test the concepts, methods, implementation strategies, patient acceptability and compliance, proposed biomarkers and clinical outcomes of such a trial with this proposed limited pilot study.
If the information obtained from this pilot study is favorable, we will submit for full funding of the multicenter USCDP clinical trial to the NIDDK and NHLBI divisions of the NIH. In order to test all aspects of the proposed trial, we intend to randomize patients into this pilot study.
- Conditions
- Diabetes, Coronary Artery Disease
- Being tested
- Strict Glycemic Control for one year post-op CABG
- Keywords
- Diabetes, CABG
- Medical subject headings
- Diabetes Mellitus, Coronary Artery Disease
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Strict Glycemic Control for one year post-op CABGDrug
Also called USCDP, Portlan Protocol
The CDE and Study Coordinator will also meet with the patient in the hospital to show how the Lifescan One-Touch Ultra II glucometer works and review the study follow-up schedule. Patients will be sent home with the Lifescan One-Touch Ultra II glucometer and a supply of strips.
Post-Discharge Period Patients will meet alternatively with the CDE and study doctor on a specific schedule including every week for the first month, every 2 weeks in the second month, and every month thereafter till the 12th month. During these sessions the BG records will be downloaded from the Lifescan One-Touch Ultra II glucometer and reviewed to see patterns and any areas that could be improved or changed.
For all patients in the study arm, the medications that are being taken and the results of glucose monitoring charts will be reviewed weekly with endocrinologists so that any additional recommendations may be made to improve glucose control.
| Study group | Role | What they receive |
|---|---|---|
| 1 | Active comparator | strict glucose control (study arm) Receives: Drug: Strict Glycemic Control for one year post-op CABG |
| 2 | No intervention | standard insulin treatment (control arm) |
What is being measured
The primary outcome is the main question the study is designed to answer.
The purpose of this study is to see how safe and effective strict glucose control is when extended beyond 3 days and hospital discharge for one year.
Measured: 3 years
Secondary outcomes (1)
Another purpose is to see how well patients can comply with the daily management of intensive glucose control for one-year as well as the study follow-up schedule.
Measured: 3 Years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted28 Mar 2008 (estimated)
- Study startMar 2009
- Primary completionFeb 2012 (estimated)
- Study completionDec 2012 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for DiabetesStudies of the same condition, open and under way.
- 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
- 120 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Providence Heart & Vascular Institute
- Sponsor type
- University, hospital or other
- Collaborators
- Sanofi, LifeScan
- Investigators
- Anthony Furnary, MD, Principal investigator, Providence Heart & Vascular Institute
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00646438
- Sponsor's protocol ID
- USCDP
- Acronym
- USCDP
- Status last verified
- Mar 2008
- First submitted
- 25 Mar 2008
- Last updated
- 4 Feb 2009
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 4 Feb 2009. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- United States CABG Diabetes Project (USCDP) Pilot Study
- ClinicalTrials.gov ID
- NCT00646438
- Acronym / sponsor ID
- USCDP / USCDP
- Conditions
- Diabetes, Coronary Artery Disease
- Keywords
- Diabetes, CABG
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 120 participants (estimated)
- Lead sponsor
- Providence Heart & Vascular InstituteUniversity, hospital or other
- Collaborators
- Sanofi, LifeScan
- Study start
- Mar 2009
- Primary completion
- Feb 2012 (estimated)
- Study completion
- Dec 2012 (estimated)
- First posted
- 28 Mar 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.
Standard care for patients with diabetes having CABG surgery at Providence St. Vincent Medical Center includes strict control of blood sugar (glucose) levels for 3 days after surgery. This is done through frequent monitoring of blood sugar levels and by giving insulin continuously through a needle into a vein (intravenously). This intensive glucose control has resulted in fewer complications such as serious infections and death, and has shortened the length of the hospital stay for patients.
This study treatment is different from standard treatment in that it extends the intensive glucose control beyond the third postoperative day to one full year. Once discharged from the hospital following the CABG procedure, the intense glucose control is done using subcutaneous insulin (a shot under the skin), oral medications, and by measuring blood sugar levels frequently.
The purpose of this study is to see how safe and effective strict glucose control is when extended beyond 3 days and hospital discharge for one year. Another purpose is to see how well patients can comply with the daily management of intensive glucose control for one-year as well as the study follow-up schedule.
Detailed description
Purpose Pilot study to gather information for "United States CABG Diabetes Project" (USCDP) Multi-center Randomized Trial.
For 14 years our research team has successfully implemented an increasingly aggressive series of intravenous insulin protocols that normalize blood glucose levels for 3 postoperative days in patients with diabetes who undergo cardiac surgery. This has resulted in significant reductions in mortality, infection and length of stay (LOS) and has normalized those outcomes to those of the population without diabetes (DM). The current protocol ends on the morning of the 3rd postoperative day.
We believe that a logical expansion of this groundbreaking work is to extend the duration of intensive glycemic control beyond the third postoperative day and into the outpatient period. However it would be impossible to do so with the continued use of CII therapy. Therefore, we propose to employ intensive subcutaneous insulin therapies and oral hypoglycemic agents to affect continued tight glycemic control following discontinuation of CII and continue such therapy beyond hospital discharge for a period of at least one year.
We hypothesize that this will lead to further reductions in major adverse cardiac outcomes in the high-risk diabetes coronary artery bypass grafts (CABG) subgroup. The optimal method to test this hypothesis is with a very large, multi-center clinical trial. However, before embarking on such a resource-consuming endeavor, we intend to test the concepts, methods, implementation strategies, patient acceptability and compliance, proposed biomarkers and clinical outcomes of such a trial with this proposed limited pilot study.
If the information obtained from this pilot study is favorable, we will submit for full funding of the multicenter USCDP clinical trial to the NIDDK and NHLBI divisions of the NIH. In order to test all aspects of the proposed trial, we intend to randomize patients into this pilot study.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| 1 | Active comparator | Drug: Strict Glycemic Control for one year post-op CABGstrict glucose control (study arm) |
| 2 | No intervention | –standard insulin treatment (control arm) |
Who may qualify
- Ages
- 18 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- Patients 18 - 80 years old
- Pre-op diagnosis of diabetes
- Scheduled for elective or urgent CABG surgery
- Able to sign informed consent for research study
Key exclusion criteria (3 listed)
- Patients less than 18 years old or greater than 80 years old
- Emergent or salvage CABG surgery
- Other surgical intervention planned in same setting ( Valve surgery, TMR, MAZE...)
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 |
|---|---|---|
| Strict Glycemic Control for one year post-op CABGAlso: USCDP, Portlan ProtocolThe CDE and Study Coordinator will also meet with the patient in the hospital to show how the Lifescan One-Touch Ultra II glucometer works and review the study follow-up schedule. Patients will be sent home with the Lifescan One-Touch Ultra II glucometer and a supply of strips. Post-Discharge Period Patients will meet alternatively with the CDE and study doctor on a specific schedule including every week for the first month, every 2 weeks in the second month, and every month thereafter till the 12th month. During these sessions the BG records will be downloaded from the Lifescan One-Touch Ultra II glucometer and reviewed to see patterns and any areas that could be improved or changed. For all patients in the study arm, the medications that are being taken and the results of glucose monitoring charts will be reviewed weekly with endocrinologists so that any additional recommendations may be made to improve glucose control. | Drug | 1 |
Primary outcome
The purpose of this study is to see how safe and effective strict glucose control is when extended beyond 3 days and hospital discharge for one year.
Time frame: 3 years
1 secondary outcome
Another purpose is to see how well patients can comply with the daily management of intensive glucose control for one-year as well as the study follow-up schedule.
Time frame: 3 Years
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 4 Feb 2009.
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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.
Anthony Furnary, MD principal investigator
Providence Heart & Vascular Institute
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study of Diabetes and Coronary Artery Disease, run by Providence Heart & Vascular Institute at 1 site in United States.
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 3 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 4 Feb 2009. 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 States. 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Eric M. Johnson, BA/CCRC (503-216-2075, eric.johnson@providence.org), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
The purpose of this study is to see how safe and effective strict glucose control is when extended beyond 3 days and hospital discharge for one year. (time frame: 3 years). 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 4 Feb 2009.