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Completed

NCT Number: NCT03520569

Effect of Hyperglycemia on Microvascular Perfusion in Healthy Adults

The investigators are studying the effects of Hyperglycemia on vascular function and insulin sensitivity on healthy adults

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Key information

Conditions

Vascular Stiffness Glucose Metabolism Disorders Hyperinsulinism Insulin Resistance Insulin Sensitivity Metabolic Diseases Nutritional and Metabolic Diseases

Age range

18 year–35 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Early Phase 1

Primary location

University of Virginia

Charlottesville, Virginia, 22908, United States

About this study

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

  • Saline + Octreotide + euglycemia;
  • Octreotide + hyperglycemia;
  • Octreotide + hyperglycemia + insulin clamp and
  • 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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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)

Treatment and study plan

Octreotide

Drug

we are using it to block insulin secretion from the pancreas

Insulin

Drug

we are using to replace basal insulin and in two protocols to raise insulin concentrations during the insulin clamp

Dextrose 20% solution

Drug

We are using dextrose to maintain glycemia level

Primary outcomes

  1. 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 .

Secondary outcomes

  1. 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.

  2. 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

Sponsors and collaborators

Lead sponsor

University of Virginia

Other

Collaborators

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

Registry information

Acronym: EJB050

Important dates

Study start
2019
Primary completion
2021
Study completion
2021
First posted
May 9, 2018
Registry last updated
May 13, 2022

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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