Metabolic Causes of Thrombosis in Type 2 Diabetes - Question 4

Completed · Early Phase 1

Conditions studied: Type 2 Diabetes

In brief

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.

Key facts

Study ID

NCT00574340

Run by

University of Maryland, Baltimore

People needed

20

Starts

2007-05-01

Expected to finish

2011-04-01

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…

• 14 (7 female/ 7 male) Type 2 diabetic patients age 18-60 yrs
• 14 (7 female/ 7 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

You may not qualify if…

• 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

Where it is running

• University of Maryland, Baltimore — Baltimore, Maryland, United States

Full record on ClinicalTrials.gov

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