Diabetes MellitusDGPNCT00428961
Diabetes Genome Project: A Prospective Registry to Identify Genetic Variation Among Diabetic Patients
An observational study of Diabetes Mellitus and Insulin Resistance, run by Saint Luke's Health System at 1 site in United States.
Trial summary
Previous scientific research has found multiple genes that affect the risk for developing heart disease or complications during the treatment of heart disease. Less is currently known about how patients with heart disease may differ on the basis of other ailments they may have and how these other ailments may affect… Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Diabetes Mellitus, Insulin Resistance, Atherosclerosis
- How many people
- 1,607 participants
- Where
- 1 siteUnited States
- Study dates
- Jul 2002to Jul 2008
- Phase
- Observational
- 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
- Healthy volunteers accepted
- Adult, Older adult
Study population: Regional population attending a single-center specialty care clinic
Who may be able to join
- Male or female gender
- Diabetes mellitus or no diabetes mellitus
- Candidate for percutaneous coronary intervention
- Informed consent
Who cannot join
None listed.
Trial locations and contacts
1 site in 1 country.
United States1 site
Saint Luke's Hospital Mid America Heart Institute
Kansas City, Missouri, 64111
About this study
Official title: Diabetic Genome Project: A Multi-Phase Prospective Registry to Identify Genetic Variation Among Diabetic Patients Undergoing Coronary Revascularization
Previous scientific research has found multiple genes that affect the risk for developing heart disease or complications during the treatment of heart disease. Less is currently known about how patients with heart disease may differ on the basis of other ailments they may have and how these other ailments may affect their treatment and prognosis. For this reason, researchers at the Mid America Heart Institute are conducting this research to find out how genes affect heart disease and recovery following angioplasty. The study will include patients with diabetes in order to determine if their genes are different from patients without diabetes.
A total of 1,607 patients were enrolled. There were 2 groups of patients selected for this study. The first group of patients included into the study will be those that are scheduled to have a diagnostic angiogram only. The second group of patients were those that had along with the angiogram a percutaneous transluminal coronary angioplasty, PTCA and or the use of a device called a coronary "stent", designed to help prop open the artery and to help avoid collapse. Samples for both groups will be stored for 30 years. After this time, all samples will be destroyed. Ultimately, we are hopeful that we will identify genes that will identify groups of patients at risk for heart disease.
Read the detailed description
A single-center prospective registry which enrolled 1,607 patients. Following informed consent, patients underwent coronary angiography and/or percutaneous coronary intervention. This project was funded by an institution grant, philanthropy, industry, and a grant from the American Diabetes Association. The long-term goal is to better understand the biological underpinnings associated with diabetic atherosclerosis and vascular risk attributable to diabetes. All patients also provided informed consent for blood banking. Blood samples were collected at baseline (fasting) and in patients undergoing PCI (random) at 2,8 and 16 hours following arterial injury. These samples were separated in aliquots of 12 x1000µL, 10x500µL EDTA plasma, 2x1,000 µL and 20x200 µL of buffy coat (baseline only) and 2x1,000 µL of RBCs (baseline only). This protocol was designed to perform multiple biomarker studies as it avoids multiple freeze thaw cycles. A plaque imaging sub-study using the IVUS-VH software platform to characterize plaque tissue enrolled 209 patients.
- Conditions
- Diabetes Mellitus, Insulin Resistance, Atherosclerosis
- Keywords
- diabetes mellitus, insulin resistance, atherosclerosis
- Medical subject headings
- Diabetes Mellitus, Insulin Resistance, Atherosclerosis
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted30 Jan 2007 (estimated)
- Study startJul 2002
- Primary completionJul 2008
- Study completionJul 2008
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for Diabetes MellitusStudies 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
- Observational
- Observational model
- Cohort
- Time perspective
- Cross-sectional
- Enrolment
- 1,607 participants (actual)
Sponsor and investigators
- Lead sponsor
- Saint Luke's Health System
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Steven P Marso, MD, Principal investigator, University of Missouri Kansas City, Saint Luke's Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00428961
- Sponsor's protocol ID
- 03-102
- Other IDs
- ADA 7-04-CR-28
- Acronym
- DGP
- Status last verified
- Oct 2021
- First submitted
- 29 Jan 2007
- Last updated
- 19 Oct 2021
- Results posted
- No
- Data monitoring committee
- Yes
Publications
Marso SP, Mehta SK, Frutkin A, House JA, McCrary JR, Kulkarni KR. Low adiponectin levels are associated with atherogenic dyslipidemia and lipid-rich plaque in nondiabetic coronary arteries. Diabetes Care. 2008 May;31(5):989-94. doi: 10.2337/dc07-2024. Epub 2008 Feb 5.
PubMed 18252902Lindsey JB, House JA, Kennedy KF, Marso SP. Diabetes duration is associated with increased thin-cap fibroatheroma detected by intravascular ultrasound with virtual histology. Circ Cardiovasc Interv. 2009 Dec;2(6):543-8. doi: 10.1161/CIRCINTERVENTIONS.109.876672. Epub 2009 Oct 13.
PubMed 20031772
Study at a glance
From the registry record, last updated by the sponsor on 19 Oct 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Diabetic Genome Project: A Multi-Phase Prospective Registry to Identify Genetic Variation Among Diabetic Patients Undergoing Coronary Revascularization
- ClinicalTrials.gov ID
- NCT00428961
- Acronym / sponsor ID
- DGP / 03-102
- Conditions
- Diabetes Mellitus, Insulin Resistance, Atherosclerosis
- Keywords
- diabetes mellitus, insulin resistance, atherosclerosis
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 1,607 participants (actual)
- Lead sponsor
- Saint Luke's Health SystemUniversity, hospital or other
- Study start
- Jul 2002
- Primary completion
- Jul 2008 (actual)
- Study completion
- Jul 2008 (actual)
- First posted
- 30 Jan 2007 (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.
Previous scientific research has found multiple genes that affect the risk for developing heart disease or complications during the treatment of heart disease. Less is currently known about how patients with heart disease may differ on the basis of other ailments they may have and how these other ailments may affect their treatment and prognosis. For this reason, researchers at the Mid America Heart Institute are conducting this research to find out how genes affect heart disease and recovery following angioplasty. The study will include patients with diabetes in order to determine if their genes are different from patients without diabetes.
A total of 1,607 patients were enrolled. There were 2 groups of patients selected for this study. The first group of patients included into the study will be those that are scheduled to have a diagnostic angiogram only. The second group of patients were those that had along with the angiogram a percutaneous transluminal coronary angioplasty, PTCA and or the use of a device called a coronary "stent", designed to help prop open the artery and to help avoid collapse. Samples for both groups will be stored for 30 years. After this time, all samples will be destroyed. Ultimately, we are hopeful that we will identify genes that will identify groups of patients at risk for heart disease.
Detailed description
A single-center prospective registry which enrolled 1,607 patients. Following informed consent, patients underwent coronary angiography and/or percutaneous coronary intervention. This project was funded by an institution grant, philanthropy, industry, and a grant from the American Diabetes Association. The long-term goal is to better understand the biological underpinnings associated with diabetic atherosclerosis and vascular risk attributable to diabetes. All patients also provided informed consent for blood banking. Blood samples were collected at baseline (fasting) and in patients undergoing PCI (random) at 2,8 and 16 hours following arterial injury. These samples were separated in aliquots of 12 x1000µL, 10x500µL EDTA plasma, 2x1,000 µL and 20x200 µL of buffy coat (baseline only) and 2x1,000 µL of RBCs (baseline only). This protocol was designed to perform multiple biomarker studies as it avoids multiple freeze thaw cycles. A plaque imaging sub-study using the IVUS-VH software platform to characterize plaque tissue enrolled 209 patients.
Study design
- Observational model
- Cohort
- Time perspective
- Cross-sectional
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
- Study population
- Regional population attending a single-center specialty care clinic
Key inclusion criteria (4 listed)
- Male or female gender
- Diabetes mellitus or no diabetes mellitus
- Candidate for percutaneous coronary intervention
- Informed consent
Key exclusion criteria (0 listed)
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Not reported in the source record.
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 19 Oct 2021.
- Results publication: PubMed 18252902Marso SP, Mehta SK, Frutkin A, House JA, McCrary JR, Kulkarni KR. Low adiponectin levels are associated with atherogenic dyslipidemia and lipid-rich plaque in nondiabetic coronary arteries. Diabetes Care. 2008 May;31(5):989-94. doi: 10.2337/dc07-2024. Epub 2008 Feb 5.
- Derived from this study: PubMed 20031772Lindsey JB, House JA, Kennedy KF, Marso SP. Diabetes duration is associated with increased thin-cap fibroatheroma detected by intravascular ultrasound with virtual histology. Circ Cardiovasc Interv. 2009 Dec;2(6):543-8. doi: 10.1161/CIRCINTERVENTIONS.109.876672. Epub 2009 Oct 13.
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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.
Steven P Marso, MD principal investigator
University of Missouri Kansas City, Saint Luke's Hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Diabetes Mellitus and Insulin Resistance, run by Saint Luke's Health System 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 0 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 19 Oct 2021. 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?
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.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT00428961, which also lists 2 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 19 Oct 2021.