Metabolic Causes of Thrombosis in Type 2 Diabetes - Question 1
SCCOR in Hemostatic and Thrombotic Diseases Project 5 - Metabolic Causes of Thrombosis in Type 2 Diabetes
2 other identifiers
interventional
32
1 country
1
Brief Summary
The purpose of this study is to learn more about why patients with diabetes have increased heart attacks, strokes and other illnesses due to blood clots causing blockage of a blood vessel. The proposed protocol will study the separate and combined effects of hyperglycemia and hyperinsulinemia on endothelial function and fibrinolytic balance in Type 2 DM. Our hypothesis is that hyperglycemia, rather than hyperinsulinemia, is responsible for the dysregulation of fibrinolytic balance in diabetics.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P25-P50 for not_applicable type-2-diabetes
Started Oct 2006
Longer than P75 for not_applicable type-2-diabetes
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
Study Start
First participant enrolled
October 1, 2006
CompletedFirst Submitted
Initial submission to the registry
December 13, 2007
CompletedFirst Posted
Study publicly available on registry
December 17, 2007
CompletedPrimary Completion
Last participant's last visit for primary outcome
December 1, 2009
CompletedStudy Completion
Last participant's last visit for all outcomes
December 1, 2010
CompletedDecember 11, 2014
December 1, 2014
3.2 years
December 13, 2007
December 10, 2014
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Endothelial function and fibrinolytic balance
2 years
Study Arms (1)
1
EXPERIMENTALInterventions
Eligibility Criteria
You may qualify if:
- ( 8 female/ 8 male) Type 2 diabetic patients age 18-60 yrs
- ( 8 female/ 8 male) Non-diabetic controls age and weight matched
- Body mass index 25-52 kgm2
- Female volunteers of childbearing potential: negative HCG pregnancy test
- Volunteers over 40 years old: normal baseline ECG
- For those with type 2 diabetes: HBA1C 6.5-10%
You may not qualify if:
- Prior history of poor health: any current or prior disease condition that alters carbohydrate metabolism and prior cardiac events and/or evidence for cardiac disease
- Uncontrolled hypertension
- History of cerebrovascular incidents
- Pregnancy
- Subjects unable to give voluntary informed consent
- Subjects with a recent medical illness
- Subjects with known liver or kidney disease
- Subjects on anticoagulant drugs, anemic, or with known bleeding diseases
- Tobacco Use
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
Vanderbilt University
Nashville, Tennessee, 37232, United States
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Stephen N. Davis, MD
Vanderbilt University
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- SINGLE
- Who Masked
- PARTICIPANT
- Purpose
- PREVENTION
- Intervention Model
- FACTORIAL
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- Department Chair
Study Record Dates
First Submitted
December 13, 2007
First Posted
December 17, 2007
Study Start
October 1, 2006
Primary Completion
December 1, 2009
Study Completion
December 1, 2010
Last Updated
December 11, 2014
Record last verified: 2014-12