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Clinical Trials/NCT02920190
NCT02920190WithdrawnPhase 4

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)

University of Miami0 sitesStarted: September 1, 2020Last updated:
Conditions
Interventions
Drugs

Trial Snapshot

Phase
Phase 4
Status
Withdrawn
Primary Endpoint
Change in Epicardial Fat Thickness

Study Overview

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.

Study Design

Study Type
Interventional
Allocation
Na
Intervention Model
Single Group
Primary Purpose
Treatment
Masking
None

Eligibility Criteria

Ages
18 Years to 70 Years (Adult, Older Adult)
Sex
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

Arms & Interventions

Liraglutide Group

Experimental

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

Intervention: Liraglutide (Drug)

Outcomes

Primary Outcomes

Change in Epicardial Fat Thickness

Time Frame: Baseline, 12 months

Epicardial fat thickness measured in mm via ultrasound

Secondary Outcomes

  • Change in serum immunoglobulins(Baseline, 12 months)
  • Change in plasma ceramide levels(Baseline, 12 months)

Investigators

Sponsor Class
Other
Responsible Party
Principal Investigator
Principal Investigator

James Hoffman, MD

Assistant Professor

University of Miami

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