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Antigen-Lipid-Driven Monoclonal Gammopathies Targeting Epicardial Fat

Primary Purpose

Monoclonal Gammopathies, Overweight, Obesity

Status
Withdrawn
Phase
Phase 4
Locations
Study Type
Interventional
Intervention
Liraglutide
Sponsored by
University of Miami
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Monoclonal Gammopathies

Eligibility Criteria

18 Years - 70 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

    Arms of the Study

    Arm 1

    Arm Type

    Experimental

    Arm Label

    Liraglutide Group

    Arm Description

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

    Outcomes

    Primary Outcome Measures

    Change in Epicardial Fat Thickness
    Epicardial fat thickness measured in mm via ultrasound

    Secondary Outcome Measures

    Change in serum immunoglobulins
    Immunoglobin levels assessed in g/L will be evaluated using serum blood samples
    Change in plasma ceramide levels
    Plasma ceramide levels will be evaluated in umol/L

    Full Information

    First Posted
    August 22, 2016
    Last Updated
    September 17, 2020
    Sponsor
    University of Miami
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    1. Study Identification

    Unique Protocol Identification Number
    NCT02920190
    Brief Title
    Antigen-Lipid-Driven Monoclonal Gammopathies Targeting Epicardial Fat
    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)
    Study Type
    Interventional

    2. Study Status

    Record Verification Date
    September 2020
    Overall Recruitment Status
    Withdrawn
    Why Stopped
    Lack of funds to cover the costs of the study medications
    Study Start Date
    September 1, 2020 (Anticipated)
    Primary Completion Date
    September 1, 2021 (Anticipated)
    Study Completion Date
    December 31, 2021 (Anticipated)

    3. Sponsor/Collaborators

    Responsible Party, by Official Title
    Principal Investigator
    Name of the Sponsor
    University of Miami

    4. Oversight

    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
    Data Monitoring Committee
    No

    5. 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.

    6. Conditions and Keywords

    Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
    Monoclonal Gammopathies, Overweight, Obesity

    7. Study Design

    Primary Purpose
    Treatment
    Study Phase
    Phase 4
    Interventional Study Model
    Single Group Assignment
    Masking
    None (Open Label)
    Allocation
    N/A
    Enrollment
    0 (Actual)

    8. Arms, Groups, and Interventions

    Arm Title
    Liraglutide Group
    Arm Type
    Experimental
    Arm Description
    Participants in this group will receive the Liraglutide intervention for 12 months
    Intervention Type
    Drug
    Intervention Name(s)
    Liraglutide
    Other Intervention Name(s)
    Victoza
    Intervention Description
    1.8 mg Liraglutide administered subcutaneously once daily for 12 consecutive months
    Primary Outcome Measure Information:
    Title
    Change in Epicardial Fat Thickness
    Description
    Epicardial fat thickness measured in mm via ultrasound
    Time Frame
    Baseline, 12 months
    Secondary Outcome Measure Information:
    Title
    Change in serum immunoglobulins
    Description
    Immunoglobin levels assessed in g/L will be evaluated using serum blood samples
    Time Frame
    Baseline, 12 months
    Title
    Change in plasma ceramide levels
    Description
    Plasma ceramide levels will be evaluated in umol/L
    Time Frame
    Baseline, 12 months

    10. Eligibility

    Sex
    All
    Minimum Age & Unit of Time
    18 Years
    Maximum Age & Unit of Time
    70 Years
    Accepts Healthy Volunteers
    No
    Eligibility Criteria
    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
    Overall Study Officials:
    First Name & Middle Initial & Last Name & Degree
    James Hoffman, MD
    Organizational Affiliation
    University of Miami
    Official's Role
    Principal Investigator

    12. IPD Sharing Statement

    Plan to Share IPD
    No

    Learn more about this trial

    Antigen-Lipid-Driven Monoclonal Gammopathies Targeting Epicardial Fat

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