Antigen-Lipid-Driven Monoclonal Gammopathies Targeting Epicardial Fat

Phase 4

Withdrawn

• Conditions: Monoclonal Gammopathies; Overweight; Obesity
• Interventions: Drug: Liraglutide

• Registration Number: NCT02920190
• Lead Sponsor: 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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2016-08-22
• Study First Submitted QC: 2016-09-28
• Study First Posted: 2016-09-30
• Status Verified: 2020-09
• Study Start: 2020-09-01
• Last Update Submitted: 2020-09-17
• Last Update Posted: 2020-09-21
• Primary Completion: 2021-09-01
• Study Completion: 2021-12-31

Recruitment & Eligibility

• Status: WITHDRAWN
• Sex: All
• Target Recruitment: Not specified

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

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

Primary Outcome Measures

Name	Time	Method
Change in Epicardial Fat Thickness	Baseline, 12 months	Epicardial fat thickness measured in mm via ultrasound

Secondary Outcome Measures

Name	Time	Method
Change in serum immunoglobulins	Baseline, 12 months	Immunoglobin levels assessed in g/L will be evaluated using serum blood samples
Change in plasma ceramide levels	Baseline, 12 months	Plasma ceramide levels will be evaluated in umol/L