The Effect of Type 1 Diabetes on Pan-Arterial Vascular Function and Insulin Sensitivity in Humans

Diabetes Type 1 Clinical Trial

— EJB046  

Official title:

The Effect of Type 1 Diabetes on Pan-Arterial Vascular Function and Insulin Sensitivity in Humans

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02490124
• Other study ID #: 17099
• Status: Completed
• Phase: N/A
• First received: July 1, 2015
• Last updated: January 12, 2016
• Start date: December 2014
• Est. completion date: June 2015

Study information

• Verified date: January 2016
• Source: University of Virginia
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Institutional Review Board
• Study type: Observational

Clinical Trial Summary

Arterial vascular disease is the major cause of morbidity and mortality for Type 1 diabetic patients (DM1). Metabolic insulin resistance (metIR), even in the absence of hyperglycemia, conveys a 1.5 to 3-fold increased CVD risk in the general population. Metabolic Insulin Resistance (MetIR) has been repeatedly shown to be prevalent in adults and adolescents with DM1. MetIR in obesity and DM2 are accompanied by vascular insulin resistance (vasIR) which is characterized by impaired vasodilatory action of insulin on resistance or microvascular vessels. VasIR has not been systematically studied in DM1. We hypothesize that in young adults DM1 impairs both baseline and insulin-responsive vascular function throughout the arterial vasculature.

Description:

In our study, 20 healthy control subjects will be compared to 20 DM1 patients (18-40 yrs). We will assess function in conduit (pulse wave velocity-PWV, flow-mediated dilation-FMD and augmentation index-AI), resistance (post-ischemic flow velocity-PIFV) and heart and skeletal muscle microvascular (contrast enhanced ultrasound-CEU) vessels before and after 2 hrs of a euglycemic insulin clamp.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 7
• Est. completion date: June 2015
• Est. primary completion date: June 2015
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Both
• Age group: 18 Years to 40 Years

Eligibility

Inclusion Criteria:

• Age 18-40

• BMI = 25

• Healthy with no chronic illness (control group only)

• Normal screening labs or no clinically significant values

• DM1 subjects will have been on insulin for at least 5 years and HbA1c <9

Exclusion Criteria:

• First degree relative with Type 1 or 2 Diabetes (for control group only)

• Smoking presently or in the past 6 months

• Medications that affect the vasculature (except ACE or ARB in DM1 subjects, although they will need to be off these drugs for 2 weeks prior to study).

• Elevated LDL cholesterol > 160

• BP <100/60 or >160/90

• Pulse oximetry <90%

• Pregnant or breastfeeding

• History of cardiovascular disease, cerebral vascular disease, peripheral vascular disease, liver disease

• Presence of an intracardiac or intrapulmonary shunt (we will screen for this by auscultation during the physical exam ).

• Known hypersensitivity to perflutren (contained in Definity)

• For DM1 group:

• HbA1c = 9

• Microalbuminuria

• Retinipathy

• Ketoacidosis within the past year.

Study Design

Observational Model: Cohort, Time Perspective: Prospective

Related Conditions & MeSH terms

• Diabetes Mellitus, Type 1
• Diabetes Type 1

Locations

Country	Name	City	State
United States	University of Virginia	Charlottesville	Virginia

Sponsors (1)

Lead Sponsor	Collaborator
University of Virginia

Country where clinical trial is conducted

United States, 

References & Publications (58)

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* Note: There are 58 references in all — Click here to view all references

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Augmentation Index	vascular measure	baseline	No
Primary	Pulse Wave Velocity	vascular measure	baseline	No
Primary	Flow Mediated Dilation	vascular measure	Baseline	No
Primary	Contrast Enhanced Ultrasound	vascular measure	baseline	No
Primary	Augmentation Index	vascular measure	after 2 hour insulin clamp	No
Primary	Pulse Wave Velocity	vascular measure	after 2 hour insulin clamp	No
Primary	Flow Mediated Dilation	vascular measure	after 2 hour insulin clamp	No
Primary	Contrast Enhanced Ultrasound	vascular measure	after 2 hour insulin clamp	No