Diabetes Genome Project: A Prospective Registry to Identify Genetic Variation Among Diabetic Patients (DGP)

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Steven P. Marso, Saint Luke's Health System
ClinicalTrials.gov Identifier:
NCT00428961
First received: January 29, 2007
Last updated: January 8, 2013
Last verified: January 2013
  Purpose

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.


Condition
Diabetes Mellitus
Insulin Resistance
Atherosclerosis

Study Type: Observational
Study Design: Observational Model: Cohort
Time Perspective: Cross-Sectional
Official Title: Diabetic Genome Project: A Multi-Phase Prospective Registry to Identify Genetic Variation Among Diabetic Patients Undergoing Coronary Revascularization

Resource links provided by NLM:


Further study details as provided by Saint Luke's Health System:

Biospecimen Retention:   Samples With DNA

Whole blood separated into 12 x1000µL, 10x500µL EDTA plasma, 2x1,000 µL and 20x200 µL of buffy coat (baseline only) and 2x1,000 µL of RBCs (baseline only)


Enrollment: 1607
Study Start Date: July 2002
Study Completion Date: July 2008
Primary Completion Date: July 2008 (Final data collection date for primary outcome measure)
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.

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   Yes
Sampling Method:   Non-Probability Sample
Study Population

Regional population attending a single-center specialty care clinic

Criteria

Inclusion Criteria:

  • Male or female gender
  • Diabetes mellitus or no diabetes mellitus
  • Candidate for percutaneous coronary intervention
  • Informed consent
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00428961

Locations
United States, Missouri
Saint Luke's Hospital Mid America Heart Institute
Kansas City, Missouri, United States, 64111
Sponsors and Collaborators
Saint Luke's Health System
Investigators
Principal Investigator: Steven P Marso, MD University of Missouri Kansas City, Saint Luke's Hospital
  More Information

Publications:
Additional publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: Steven P. Marso, Principal Investigator, Saint Luke's Health System
ClinicalTrials.gov Identifier: NCT00428961     History of Changes
Other Study ID Numbers: 03-102, ADA 7-04-CR-28
Study First Received: January 29, 2007
Last Updated: January 8, 2013
Health Authority: United States: Institutional Review Board

Keywords provided by Saint Luke's Health System:
diabetes mellitus
insulin resistance
atherosclerosis

Additional relevant MeSH terms:
Arteriosclerosis
Atherosclerosis
Diabetes Mellitus
Insulin Resistance
Arterial Occlusive Diseases
Cardiovascular Diseases
Endocrine System Diseases
Glucose Metabolism Disorders
Hyperinsulinism
Metabolic Diseases
Vascular Diseases

ClinicalTrials.gov processed this record on October 22, 2014