Metabolic Causes of Thrombosis in Type 2 Diabetes - Question 4
SCCOR in Hemostatic and Thrombotic Diseases Project 5 - Metabolic Causes of Thrombosis in Type 2 Diabetes
2 other identifiers
interventional
20
1 country
1
Brief 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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P25-P50 for early_phase_1 type-2-diabetes
Started May 2007
Typical duration for early_phase_1 type-2-diabetes
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
Study Start
First participant enrolled
May 1, 2007
CompletedFirst Submitted
Initial submission to the registry
December 13, 2007
CompletedFirst Posted
Study publicly available on registry
December 17, 2007
CompletedPrimary Completion
Last participant's last visit for primary outcome
April 1, 2011
CompletedStudy Completion
Last participant's last visit for all outcomes
April 1, 2011
CompletedResults Posted
Study results publicly available
September 1, 2014
CompletedSeptember 12, 2019
September 1, 2019
3.9 years
December 13, 2007
May 27, 2014
September 10, 2019
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Percent Changes in Endothelial Function as Measured by Flow Mediated Dilation by 2D Doppler Ultrasound on Day 2
A measure of the baseline arterial dilation on day 2 is compared to the post intervention measure of dilation of the brachial artery on Day 2.
baseline on day 2 and ~6 hours later at end of glucose clamp period
Study Arms (2)
Control study then antecedent hypoglycemia study group
ACTIVE COMPARATORDay 1 euglycemia, day 2 hypoglycemia Hyperinsulinemic Hypoglycemic Clamp: hyperinsulinemic glucose clamp separated by 8 weeks then participants proceeded to antecedent hypoglycemia study Day 1 hypoglycemia, Day 2 hypoglycemia
Antecedent Hypoglycemic clamp study
ACTIVE COMPARATORDay 1 hypoglycemia, day 2 hypoglycemia Hyperinsulinemic Hypoglycemic Clamp: hyperinsulinemic glucose clamp separated by 8 weeks then participants proceeded to control study Day 1 euglycemia, Day 2 hypoglycemia
Interventions
all participants received (2) hyperinsulinemic glucose clamp studies separated by 8 weeks
Eligibility Criteria
You may qualify if:
- (7 female/ 7 male) Type 2 diabetic patients age 18-60 yrs
- (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
- 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
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
University of Maryland, Baltimore
Baltimore, Maryland, 21201, United States
Related Publications (2)
Joy NG, Tate DB, Younk LM, Davis SN. Effects of Acute and Antecedent Hypoglycemia on Endothelial Function and Markers of Atherothrombotic Balance in Healthy Humans. Diabetes. 2015 Jul;64(7):2571-80. doi: 10.2337/db14-1729. Epub 2015 Feb 18.
PMID: 25695946RESULTGogitidze Joy N, Hedrington MS, Briscoe VJ, Tate DB, Ertl AC, Davis SN. Effects of acute hypoglycemia on inflammatory and pro-atherothrombotic biomarkers in individuals with type 1 diabetes and healthy individuals. Diabetes Care. 2010 Jul;33(7):1529-35. doi: 10.2337/dc09-0354.
PMID: 20587723DERIVED
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Results Point of Contact
- Title
- Dr. Stephen N. Davis
- Organization
- University of Maryland, Baltimore
Study Officials
- PRINCIPAL INVESTIGATOR
Stephen N. Davis, MD
University of Maryland, Baltimore
Publication Agreements
- PI is Sponsor Employee
- Yes
- Restrictive Agreement
- No
Study Design
- Study Type
- interventional
- Phase
- early phase 1
- Allocation
- RANDOMIZED
- Masking
- SINGLE
- Who Masked
- PARTICIPANT
- Purpose
- PREVENTION
- Intervention Model
- CROSSOVER
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- Professor
Study Record Dates
First Submitted
December 13, 2007
First Posted
December 17, 2007
Study Start
May 1, 2007
Primary Completion
April 1, 2011
Study Completion
April 1, 2011
Last Updated
September 12, 2019
Results First Posted
September 1, 2014
Record last verified: 2019-09