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)
Conditions
Interventions
Drugs
Trial Snapshot
- Phase
- Phase 4
- Status
- Withdrawn
- Sponsor
- University of Miami
- 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
James Hoffman, MD
Assistant Professor
University of Miami
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