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Completed

NCT Number: NCT03534479

Human IgGs and Endothelial Function in Vivo in Humans

Endothelial dysfunction and insulin resistance play a key role in the onset and development of atherosclerosis, cardiovascular diseases, and diabetes. Data in mice models have recently demonstrated that circulating immunoglobulins G (IgG) could be involved in the process. Patients with common variable immunodeficiency (CVID), who are characterized by low circulating levels of IgG, might represent an ideal model to clarify the role played in vivo in humans by circulating IgG. Polyclonal IgG, obtained from multiple donors, given intravenously (IVIgG), are used to treat various immunodeficiencies and autoimmune diseases, including CVID. By using this disease and its treatment by IVIgG as a model, aim of the current study is to clarify whether IgG affect endothelial function and insulin sensitivity in humans in vivo and whether the action of IgG on the endothelium involves a direct interaction with the endothelial cells.

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Key information

Conditions

Common Variable Immunodeficiency Immune System Diseases Immunologic Deficiency Syndromes

Age range

18 year–70 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Federico II University Hospital

Naples, 80131, Italy

About this study

For this purposes, 24 patients with CVID, receiving the last therapeutic dose of IVIgG infusion 5-weeks before the baseline measurements (CVID-IVIgG group), are studied. In all subjects, endothelial function is evaluated as flow mediated dilation (FMD) of the brachial artery, measured by ultrasonographic technique at baseline and 1, 7, 14, and 21 days after IVIgG infusion. FMD is also measured in a group of IVIgG naive CVID patients (number of patients recruited depending on availability) and a group of control healthy subjects. The latter FMD measurements serve only as a mere reference of pathological or normal values in condition of deficiency or normal levels of circulating IgG and are not used for primary outcome evaluation. To dissect further the mechanisms of improved endothelial function after IVIgG infusion, we investigate the role of human IgG on the production of Nitric Oxide (NO) in vitro on Human Coronary Artery Endothelial Cells (HCAEC) isolated from normal human coronary arteries.

Who can participate

Healthy volunteers accepted: No

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

Inclusion criteria

  • Common Variable Immunodeficiency

Exclusion criteria

  • Cancer, liver Cirrhosis, recent acute myocardial infarction, treatment with nitroderivates, Reynaud syndrome, heart failure

Treatment and study plan

Polyclonal IgG

Drug

Measurement of vascular reactivity before and after Infusion of plyclonal Immunoglobulins G in patients with Common variable immunodeficiency

Other names: Immunoglobulins

Primary outcomes

  1. Change in Endothelial Mediated Vascular Reactivity

    Time frame: 1 day, 1 week, 2 weeks or three weeks after polyclonal IgG infusion

    Change in vascular reactivity measured by Flow Mediated Dilation of the brachial artery

Secondary outcomes

  1. Change in insulin sensitivity

    Time frame: 1 day, 1 week, 2 weeks or three weeks after polyclonal IgG infusion

    Change in insulin sensitivity measured as change in the Homeostasis model assessment (HOMA-IR) index

Sponsors and collaborators

Lead sponsor

Federico II University

Other

Registry information

Official study title

Effects of Intravenous Human Polyclonal Immunoglobulins G Infusion on Endothelial Function and Insulin Sensitivity in Humans

Acronym: HIGH

Important dates

Study start
2010
Primary completion
2013
Study completion
2013
First posted
May 23, 2018
Registry last updated
May 23, 2018

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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