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SCCOR in Hemostatic and Thrombotic Diseases Project 5 - Metabolic Causes of Thrombosis in Type 2 Diabetes

This study is currently Recruiting

July 2011 By University of Maryland

First Recieved on December 13, 2007

Last Updated on July 31, 2011

Sponsor: University of Maryland
Collaborators: National Heart, Lung, and Blood Institute (NHLBI)
Information provided by: University of Maryland
Identifier: NCT00574340

Purpose

Hypoglycemia (low blood glucose level) occurs frequently in intensively treated patients with diabetes. Although hypoglycemia was thought to occur almost exclusively in T1DM, with the advent of improved metabolic control in T2DM, the incidence of hypoglycemia is rising in these patients. Therefore in this application, we will test the novel hypothesis that prior hypoglycemia will result in (cardiovascular complications) during subsequent hypoglycemia.

Study Type: Interventional
Study Design: Allocation: Randomized, Intervention Model: Factorial Assignment, Masking: Single Blind (Subject), Primary Purpose: Prevention

Eligibility

Ages Eligible for Study:18 Years
Genders Eligible for Study:Both
Accepts Healthy Volunteers:Accepts Healthy Volunteers
Criteria

Inclusion Criteria - 16 (8 female/ 8 male) Type 2 diabetic patients age 18-60 yrs - 16 (8 female/ 8 male) Non-diabetic controls age and weight matched - Body mass index >20 kg/m2 - Normal results of routine blood test to screen for hepatic, renal, and hematological abnormalities - Female volunteers of childbearing potential: negative HCG pregnancy test - Volunteers over 40 years old: normal baseline cardiac stress test - For those with type 2 diabetes: HBA1C >5.5% - For those with type 2 diabetes: diabetes < 20 years - For those with type 2 diabetes: C-peptide >0.2 nmol (1.1-4.4 ng/ml). If c-peptide is abnormal or there is a clinical suspicion of type 1 diabetes, MODY, or LADA, Anti-Islet cell (negative) and Glutamic Acid Decarboxylase (GAD) antibody negative (0.0-1.5 U/ml) will be performed Exclusion Criteria - Uncontrolled hypertension - History of cerebrovascular incidents - Pregnancy - Subjects unable to give voluntary informed consent - Subjects with a recent medical illness - Subjects on anticoagulant drugs, anemic, or with known bleeding diseases - Tobacco Use Physical Exam Exclusion Criteria - Blood Pressure greater than 150/95 - Clinically significant Cardiac Abnormalities (e.g. Heart Failure, Arrhythmias, ischemic tachycardia, S-T segment deviations, ect.) from history or from cardiac stress testing - Pneumonia - Hepatic Failure/Jaundice - Renal Failure - Acute Cerebrovascular/ Neurological deficit - Fever greater than 38.0 C Screening blood tests exclusions according to protocol

Investigators

  • Investigator: Stephen N. Davis, MD - Principal Investigator - University of Maryland

Locations

  • University of Maryland, Baltimore

    Baltimore, Maryland 21201 United States

Conditions related to this trial:

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