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

NCT ID: NCT02490124

Last Updated: 2016-01-13

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Total Enrollment

7 participants

Study Classification

OBSERVATIONAL

Study Start Date

2014-12-31

Study Completion Date

2015-06-30

Brief Summary

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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.

Detailed Description

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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.

Conditions

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Diabetes Type 1

Study Design

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Observational Model Type

COHORT

Study Time Perspective

PROSPECTIVE

Study Groups

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Type 1 Diabetic

Type 1 Diabetic

No interventions assigned to this group

Control

normal healthy control

No interventions assigned to this group

Eligibility Criteria

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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.
Minimum Eligible Age

18 Years

Maximum Eligible Age

40 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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University of Virginia

OTHER

Sponsor Role lead

Responsible Party

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Eugene Barrett

Professor Eugene Barrett MD PhD

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Eugene J. B, MD, PhD

Role: PRINCIPAL_INVESTIGATOR

University of Virginia

Locations

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University of Virginia

Charlottesville, Virginia, United States

Site Status

Countries

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United States

References

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Other Identifiers

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17099

Identifier Type: -

Identifier Source: org_study_id

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