Early Phase 1 N=20 Randomized Single-blind Prevention

Metabolic Causes of Thrombosis in Type 2 Diabetes - Question 4

Type 2 Diabetes

Bottom Line

View on ClinicalTrials.gov: NCT00574340 ↗

Enrolled (actual)

Serious AEs

0.0%

Results posted

Sep 2014

Primary outcome: Primary: Percent Changes in Endothelial Function as Measured by Flow Mediated Dilation by 2D Doppler Ultrasound on Day 2 — 2; 7 percentage of change

Study Design & Population

Study type: Interventional
Phase: Early Phase 1
Interventions: Hyperinsulinemic Hypoglycemic Clamp (Other)
Age: Adult · 18+ yrs
Sex: All
Sponsor: University of Maryland, Baltimore
Primary completion: Apr 2011

Outcome Measures

Outcome	Result	p-value
PRIMARY Percent Changes in Endothelial Function as Measured by Flow Mediated Dilation by 2D Doppler Ultrasound on Day 2	2; 7	—

Summary

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.

Eligibility Criteria

Inclusion Criteria

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 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

View full record on ClinicalTrials.gov →

Data sourced from ClinicalTrials.gov (NCT00574340). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.