Effect of Hyperglycemia on Microvascular Perfusion in Healthy Adults (EJB050)

April 20, 2022 updated by: Eugene Barrett, University of Virginia
The investigators are studying the effects of Hyperglycemia on vascular function and insulin sensitivity on healthy adults

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Detailed Description

The investigators will study 22 healthy subjects (18-35 yrs) four times as follows:

  1. Saline + Octreotide + euglycemia;
  2. Octreotide + hyperglycemia;
  3. Octreotide + hyperglycemia + insulin clamp and
  4. Octreotide + Euglycemia + insulin clamp.

The sequence of admissions will be assigned randomly. The investigators will assess function in conduit (pulse wave velocity-PWV, augmentation index-AI and flow-mediated dilation-FMD), resistance (post-ischemic flow velocity-PIFV) and heart and skeletal muscle microvascular (contrast enhanced ultrasound-CEU) vessels.

This work will:

a) identify whether vascular stiffness and indices of NO action are impaired throughout the arterial tree with hyperglycemia.

Study Type

Interventional

Enrollment (Actual)

15

Phase

  • Early Phase 1

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • Virginia
      • Charlottesville, Virginia, United States, 22908
        • University of Virginia

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 35 years (ADULT)

Accepts Healthy Volunteers

Yes

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • Healthy with no chronic illness
  • Age 18-35
  • Normal BMI (18-25)
  • Normal screening labs or no clinically significant values

Exclusion Criteria:

  • First degree relative with Type 2 Diabetes
  • Smoking presently or in the past 6 months
  • Medications that affect the vasculature
  • Overweight or other indications of insulin resistance
  • Elevated LDL cholesterol > 160
  • Elevated BP > 140/90
  • History of congestive heart failure, ischemic heart disease, severe pulmonary disease, liver or kidney disease, bleeding disorders
  • Any vascular disease such as myocardial infarction, stroke, peripheral vascular disease
  • Presence of an intracardiac or intrapulmonary shunt (we will screen for this by auscultation during the physical exam by PI).
  • Pregnant or breastfeeding.
  • Known hypersensitivity to perflutren (contained in Definity)

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: BASIC_SCIENCE
  • Allocation: RANDOMIZED
  • Interventional Model: CROSSOVER
  • Masking: NONE

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
ACTIVE_COMPARATOR: Octreotide- Euglycemia
octreotide is 30 ng/kg/min x 240 min insulin 0.15mU/kg/min x 240 min Dextrose 20% at variable rate to maintain euglycemia for 240 min
Drug: Octreotide
we are using it to block insulin secretion from the pancreas
Drug: Insulin
we are using to replace basal insulin and in two protocols to raise insulin concentrations during the insulin clamp
Drug: Dextrose 20% solution
We are using dextrose to maintain glycemia level
ACTIVE_COMPARATOR: Octreotide - Euglycemia- insulin clamp
octreotide is 30 ng/kg/min x 330 min insulin 0.15mU/kg/min x 210 min insulin 1.0mU/kg/min x 120 min Dextrose 20% at variable rate to maintain euglycemia for 330 min
Drug: Octreotide
we are using it to block insulin secretion from the pancreas
Drug: Insulin
we are using to replace basal insulin and in two protocols to raise insulin concentrations during the insulin clamp
Drug: Dextrose 20% solution
We are using dextrose to maintain glycemia level
ACTIVE_COMPARATOR: Octreotide- hyperglycemia
octreotide is 30 ng/kg/min x 330 min insulin 0.15mU/kg/min x 330 min Dextrose 20% at variable rate to maintain euglycemia for 90 min Dextrose 20% at variable rate to maintain hyperglycemia for 240 min
Drug: Octreotide
we are using it to block insulin secretion from the pancreas
Drug: Insulin
we are using to replace basal insulin and in two protocols to raise insulin concentrations during the insulin clamp
Drug: Dextrose 20% solution
We are using dextrose to maintain glycemia level
ACTIVE_COMPARATOR: Octreotide- hyperglycemia - insulin clamp
octreotide is 30 ng/kg/min x 330 min insulin 0.15mU/kg/min x 210 min insulin 1.0mU/kg/min x 120 min Dextrose 20% at variable rate to maintain euglycemia for 90 min Dextrose 20% at variable rate to maintain hyperglycemia for 240 min
Drug: Octreotide
we are using it to block insulin secretion from the pancreas
Drug: Insulin
we are using to replace basal insulin and in two protocols to raise insulin concentrations during the insulin clamp
Drug: Dextrose 20% solution
We are using dextrose to maintain glycemia level

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Change in Flow Mediated Dilation (FMD) Between Baseline and After 2 Hour Insulin Clamp
Time Frame: baseline and after 2 hour insulin clamp
Flow mediated dilation measures the change in brachial diameter in response to 5 minutes of ischemia using B-mode ultrasound. It provides an index of nitric oxide generation by the endothelium .
baseline and after 2 hour insulin clamp

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Change in Augmentation Index Between Baseline and After 2 Hour Insulin Clamp
Time Frame: baseline and after 2 hour insulin clamp
The augmentation index (AIx) measured at the radial artery is a measure of systemic arterial stiffness, and is defined as the ratio of augmentation (Δ P) to central pulse pressure and expressed as percent. AIx = (ΔP/PP) x 100, where P = pressure and PP = Pulse Pressure. Higher percentages indicate increased arterial stiffness.
baseline and after 2 hour insulin clamp
Change in Pulse Wave Velocity (PWV) Between Baseline and After 2 Hour Insulin Clamp
Time Frame: baseline and after 2 hour insulin clamp
The time required for a blood pressure wave to travel from the carotid to the femoral artery was measured in meter/sec. This is a measurement of central artery stiffness. Higher numbers indicate stiffer vessels
baseline and after 2 hour insulin clamp

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

University of Virginia

Collaborators

National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (ACTUAL)

February 4, 2019

Primary Completion (ACTUAL)

April 1, 2021

Study Completion (ACTUAL)

April 1, 2021

Study Registration Dates

First Submitted

March 8, 2018

First Submitted That Met QC Criteria

May 8, 2018

First Posted (ACTUAL)

May 9, 2018

Study Record Updates

Last Update Posted (ACTUAL)

May 13, 2022

Last Update Submitted That Met QC Criteria

April 20, 2022

Last Verified

April 1, 2022

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 19948
  • T32DK007646 (NIH)

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

Yes

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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