Metabolic Causes of Thrombosis in Type 2 Diabetes - Question 4

Early Phase 1

Completed

• Conditions: Type 2 Diabetes
• Interventions: Other: Hyperinsulinemic Hypoglycemic Clamp

• Registration Number: NCT00574340
• Lead Sponsor: University of Maryland, Baltimore

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.

Detailed Description

This study will test the hypothesis that 1) hypoglycemia causes a prothrombotic state and defective endothelial function and 2) episodes of repeated hypoglycemia will result in greater impairments of endothelial function and an increased prothrombotic tendency. Preliminary data in healthy men demonstrates that hypoglycemia can dramatically increase PAI-1 levels and the PAI-1 to tPA ratio, thereby creating a prothrombotic state. Whether this also occurs in type 2 DM patients is unknown. Furthermore, the effects of hypoglycemia on endothelial function in T2DM are also unknown.

Study Timeline

• Study Start: 2007-05
• Study First Submitted: 2007-12-13
• Study First Submitted QC: 2007-12-13
• Study First Posted: 2007-12-17
• Primary Completion: 2011-04
• Study Completion: 2011-04
• Results First Submitted: 2014-05-27
• Results First Submitted QC: 2014-08-22
• Results First Posted: 2014-09-01
• Status Verified: 2019-09
• Last Update Submitted: 2019-09-10
• Last Update Posted: 2019-09-12

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 20

Inclusion Criteria

Not provided

Exclusion Criteria

Not provided

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: CROSSOVER

Arm && Interventions

Group	Intervention	Description
Control study then antecedent hypoglycemia study group	Hyperinsulinemic Hypoglycemic Clamp	Day 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	Hyperinsulinemic Hypoglycemic Clamp	Day 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

Primary Outcome Measures

Name	Time	Method
Percent Changes in Endothelial Function as Measured by Flow Mediated Dilation by 2D Doppler Ultrasound on Day 2	baseline on day 2 and ~6 hours later at end of glucose clamp period	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.

Trial Locations

Locations (1)

University of Maryland, Baltimore; 🇺🇸 Baltimore, Maryland, United States