Metabolic Causes of Thrombosis in Type 2 Diabetes Mellitus
Completed · Early Phase 1
Conditions studied: Type 2 Diabetes
In brief
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 high glucose and high fats on certain cardiovascular responses in Type 2 DM.
Key facts
- Study ID
- NCT00829699
- Run by
- University of Maryland, Baltimore
- People needed
- 31
- Starts
- 2009-07-01
- Expected to finish
- 2014-04-01
- Last updated by the study team
- 2019-09-12
Who can join
Age: 18 and older, up to 60. Sex: any. Healthy volunteers: accepted.
You may qualify if…
- 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
You may not qualify if…
- 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
Where it is running
- Univerisity of Maryland, Baltimore — Baltimore, Maryland, United States
Full record on ClinicalTrials.gov
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