Status:
COMPLETED
Metabolic Causes of Thrombosis in Type 2 Diabetes Mellitus
Lead Sponsor:
University of Maryland, Baltimore
Collaborating Sponsors:
National Heart, Lung, and Blood Institute (NHLBI)
Conditions:
Type 2 Diabetes
Eligibility:
All Genders
18-60 years
Phase:
EARLY_PHASE1
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 propose...
Detailed Description
Currently 75-80% of diabetes mellitus (DM) patients die due to thrombotic causes. Data from the Centers for Disease Control and Prevention released in 2000 indicated that mortality due to coronary art...
Eligibility Criteria
Inclusion
- Inclusion Criteria
- 16 Type 2 diabetic patients age 18 - 60 yrs
- 16 Non-diabetic controls age 18-60 yrs
- Body mass index \>20 kg/m2
- Female volunteers of childbearing potential: negative urine pregnancy test
- Volunteers over 40 years old: an ECG with no clinically significant conduction or ischemic changes.
- For those with type 2 diabetes: HBA1C \> 5.5%
- For those with type 2 diabetes: C-peptide \>0.2 nmol, If C-peptide is abnormal or there is a clinical suspicion for type 1 diabetes, MODY or LADA, anti-islet cell and anti-GAD antibodies will be assessed to establish the diagnosis of type 2 diabetes vs. type 1/LADA/MODY.
- PT (time) 12.8-14.6 seconds, PTT (time) 25-38 seconds
- Exclusion Criteria
- Any current disease condition that alters carbohydrate metabolism (other than type 2 DM) and/or evidence for clinically significant cardiac disease
- Uncontrolled hypertension
- Pregnancy
- Subjects unable to give voluntary informed consent
- Subjects with history of pancreatitis
- Subjects on anticoagulant drugs, anemic, or with known bleeding diseases
- Subjects with history of GI bleeding requiring treatment
- Tobacco Use
- Subjects with history of heparin-induced thrombocytopenia or heparin allergy
- Subjects with severe egg or legume (soybean) allergy
- Abnormal results following screening tests and physical examination that is clinically significant:
- Medical history/Physical Exam Exclusion Criteria
- Fever greater than 38 degrees C at screening or study initiation
- Uncontrolled severe hypertension (i.e., blood pressure greater than 160/100)
- Cardiac Abnormalities (e.g. Heart Failure, Arrhythmia, Cardiomyopathy, ischemic tachycardia, S-T segment deviations, etc.,) from history or ECG testing in subjects \> 40 years old.
- Diagnosed Pneumonia
- Hepatic Failure/Jaundice
- Clinically significant coagulopathy
- Renal Failure
- Acute Cerebrovascular/ Neurological deficit
- Screening Laboratory Tests Exclusion Criteria according to protocol
Exclusion
Key Trial Info
Start Date :
July 1 2009
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
April 1 2014
Estimated Enrollment :
31 Patients enrolled
Trial Details
Trial ID
NCT00829699
Start Date
July 1 2009
End Date
April 1 2014
Last Update
September 12 2019
Active Locations (1)
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1
Univerisity of Maryland, Baltimore
Baltimore, Maryland, United States, 21201