Human IgGs and Endothelial Function in Vivo in Humans

NCT03534479 | Completed

• 1 other identifier: HypoIgG1
• Study Type: interventional
• Target: 24
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Common Variable Immunodeficiency

Outcome Measures

Primary Outcomes (1)

• Change in Endothelial Mediated Vascular Reactivity

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

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

Secondary Outcomes (1)

• Change in insulin sensitivity

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

Study Arms (1)

CVID-IVIgG, polyclonal IgG i.v. infusion

EXPERIMENTAL

The patients of the CVID-IVIgG, polyclonal IgG infusion, group are studied five weeks from their last therapeutic polyclonal IgG i.v. infusion (IVIgG). On the mornings of day 0, vascular reactivity of the brachial artery, assessed as Flow mediated dilation (FMD), is measured and blood collected for biochemistry (baseline). Immediately after the FMD measurements and the blood collection, the 24 patients receive half dose of IVIgG necessary to treat their disease (400 mg/kg body weight in 10% solution). Twenty-four hours later, before infusing the second half of the dose of the IVIgG, vascular reactivity is again measured and blood collected. Vascular reactivity is again measured 1, 2, and 3 weeks after the first IVIgG infusion.

Drug: Polyclonal IgG

Interventions

Polyclonal IgG DRUG

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

Also known as: Immunoglobulins

CVID-IVIgG, polyclonal IgG i.v. infusion

Eligibility Criteria

• Age: 18 Years - 70 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Common Variable Immunodeficiency

You may not qualify if:

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

Sponsors & Collaborators

• Federico II University: lead

Study Sites (1)

Federico II University Hospital

Napoli, 80131, Italy

Location

MeSH Terms

Conditions

Common Variable Immunodeficiency

Interventions

technetium TC 99m polyclonal IgG; Immunoglobulins

Condition Hierarchy (Ancestors)

Immunologic Deficiency Syndromes; Immune System Diseases

Intervention Hierarchy (Ancestors)

Immunoproteins; Blood Proteins; Proteins; Amino Acids, Peptides, and Proteins; Serum Globulins; Globulins

Study Officials

• RAFFAELE NAPOLI, MD

  1990

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: BASIC SCIENCE
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Associate Professor

Study Record Dates

• First Submitted: May 10, 2018
• First Posted: May 23, 2018
• Study Start: April 1, 2010
• Primary Completion: April 1, 2013
• Study Completion: April 1, 2013
• Last Updated: May 23, 2018

Record last verified: 2018-05

Data Sharing

• IPD Sharing: Will not share

Locations

IT (1)