Working…
COVID-19 is an emerging, rapidly evolving situation.
Get the latest public health information from CDC: https://www.coronavirus.gov.

Get the latest research information from NIH: https://www.nih.gov/coronavirus.
ClinicalTrials.gov
ClinicalTrials.gov Menu

Antigen-Lipid-Driven Monoclonal Gammopathies Targeting Epicardial Fat

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT02920190
Recruitment Status : Withdrawn (Lack of funds to cover the costs of the study medications)
First Posted : September 30, 2016
Last Update Posted : September 21, 2020
Sponsor:
Information provided by (Responsible Party):
James Hoffman, MD, University of Miami

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
Monoclonal Gammopathies Overweight Obesity Drug: Liraglutide Phase 4

Layout table for study information
Study Type : Interventional  (Clinical Trial)
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)
Estimated Study Start Date : September 1, 2020
Estimated Primary Completion Date : September 1, 2021
Estimated Study Completion Date : December 31, 2021


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 Name: Victoza




Primary Outcome Measures :
  1. Change in Epicardial Fat Thickness [ Time Frame: Baseline, 12 months ]
    Epicardial fat thickness measured in mm via ultrasound


Secondary Outcome Measures :
  1. Change in serum immunoglobulins [ Time Frame: Baseline, 12 months ]
    Immunoglobin levels assessed in g/L will be evaluated using serum blood samples

  2. Change in plasma ceramide levels [ Time Frame: Baseline, 12 months ]
    Plasma ceramide levels will be evaluated in umol/L



Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Layout table for eligibility information
Ages Eligible for Study:   18 Years to 70 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02920190


Sponsors and Collaborators
University of Miami
Investigators
Layout table for investigator information
Principal Investigator: James Hoffman, MD University of Miami
Layout table for additonal information
Responsible Party: James Hoffman, MD, Assistant Professor, University of Miami
ClinicalTrials.gov Identifier: NCT02920190    
Other Study ID Numbers: 20160568
First Posted: September 30, 2016    Key Record Dates
Last Update Posted: September 21, 2020
Last Verified: September 2020
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

Layout table for additional information
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:
Layout table for MeSH terms
Paraproteinemias
Monoclonal Gammopathy of Undetermined Significance
Overweight
Body Weight
Blood Protein Disorders
Hematologic Diseases
Immunoproliferative Disorders
Immune System Diseases
Hypergammaglobulinemia
Liraglutide
Hypoglycemic Agents
Physiological Effects of Drugs
Incretins
Hormones
Hormones, Hormone Substitutes, and Hormone Antagonists