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Antigen-Lipid-Driven Monoclonal Gammopathies Targeting Epicardial Fat

Sponsor
University of Miami (Other)
Overall Status
Withdrawn
CT.gov ID
NCT02920190
Collaborator
(none)
0
Enrollment
1
Arm
16
Anticipated Duration (Months)

Study Details

Study Description

Brief Summary

The purpose of this research study is to learn about the effect of Liraglutide (Victoza) on the fat of the heart and some fat cells in blood.

Condition or Disease Intervention/Treatment Phase
Phase 4

Study Design

Study Type:
Interventional
Actual Enrollment :
0 participants
Allocation:
N/A
Intervention Model:
Single Group Assignment
Masking:
None (Open Label)
Primary Purpose:
Treatment
Official Title:
Reduction of Antigen-Lipid-Driven Monoclonal Gammopathies by Targeting Epicardial Fat and Its Lipids Content With Liraglutide: A Glucagon Like Peptide-1 Receptor Analogue (GLP-1RA)
Anticipated Study Start Date :
Sep 1, 2020
Anticipated Primary Completion Date :
Sep 1, 2021
Anticipated Study Completion Date :
Dec 31, 2021

Arms and Interventions

Arm Intervention/Treatment
Experimental: Liraglutide Group

Participants in this group will receive the Liraglutide intervention for 12 months

Drug: Liraglutide
1.8 mg Liraglutide administered subcutaneously once daily for 12 consecutive months
Other Names:
  • Victoza

    		•

    Outcome Measures

    Primary Outcome Measures

    1. Change in Epicardial Fat Thickness [Baseline, 12 months]

      Epicardial fat thickness measured in mm via ultrasound

    Secondary Outcome Measures

    1. Change in serum immunoglobulins [Baseline, 12 months]

      Immunoglobin levels assessed in g/L will be evaluated using serum blood samples

    2. Change in plasma ceramide levels [Baseline, 12 months]

      Plasma ceramide levels will be evaluated in umol/L

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    18 Years to 70 Years
    Sexes Eligible for Study:
    All
    Accepts Healthy Volunteers:
    No
    Inclusion Criteria:

    • BMI ≥27 kg/m2

    • At least one overweight/obesity related comorbidity (such as type 2 diabetes, pre-diabetes [IFG, IGT], hypertension, dyslipidemia)

    • Age > 18 and < 70 years old

    Exclusion Criteria:

    • Known contra-indications to Liraglutide, such as previous history of pancreatitis or medullary thyroid carcinoma, personal or family history of MEN, in accordance with risks and safety information included in the latest updated Prescribing Information for Victoza®

    • Type 1 diabetes, as defined by American Diabetes Association (ADA) criteria

    • Insulin dependent or treated type 2 diabetes

    • Current use of other injectable incretins

    • History of diabetes ketoacidosis

    • Advanced Chronic Kidney Disease, as defined by Glomerular Filtration Rate (GFR) < 30 mL/min/1.73m2

    • Clinical signs or symptoms of New York Heart Association (NYHA) class III-IV heart failure

    • Clinical or laboratory evidences of chronic active liver diseases

    • Acute or chronic infective diseases

    • Known or suspected allergy to Liraglutide, excipients, or related products

    • Pregnant, breast-feeding or the intention of becoming pregnant

    • Females of childbearing potential who are not using adequate contraceptive methods

    Contacts and Locations

    Locations

    No locations specified.

    Sponsors and Collaborators

    • University of Miami

    Investigators

    • Principal Investigator: James Hoffman, MD, University of Miami

    Study Documents (Full-Text)

    None provided.

    More Information

    Publications

    None provided.
    Responsible Party:
    James Hoffman, MD, Assistant Professor, University of Miami
    ClinicalTrials.gov Identifier:
    NCT02920190
    Other Study ID Numbers:
    • 20160568
    First Posted:
    Sep 30, 2016
    Last Update Posted:
    Sep 21, 2020
    Last Verified:
    Sep 1, 2020
    Individual Participant Data (IPD) Sharing Statement:
    No
    Plan to Share IPD:
    No
    Studies a U.S. FDA-regulated Drug Product:
    Yes
    Studies a U.S. FDA-regulated Device Product:
    No
    Product Manufactured in and Exported from the U.S.:
    No
    Additional relevant MeSH terms:
    Paraproteinemias
    Monoclonal Gammopathy of Undetermined Significance
    Overweight
    Liraglutide

    Study Results

    No Results Posted as of Sep 21, 2020