Antigen-Lipid-Driven Monoclonal Gammopathies Targeting Epicardial Fat

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.

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)

Conditions
-----------------
Monoclonal Gammopathies, Overweight, Obesity

Intervention / Treatment
-----------------
* Drug: Liraglutide


Participation Criteria
=================
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

Ages Eligible for Study
-----------------
Minimum Age: 18 Years
Maximum Age: 70 Years

Sexes Eligible for Study
-----------------
All

Accepts Healthy Volunteers
-----------------
No

Study Plan
=================
How is the study designed?
-----------------

Design Details

Primary Purpose: Treatment
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Liraglutide Group<br>Participants in this group will receive the Liraglutide intervention for 12 months | Drug: Liraglutide<br>* 1.8 mg Liraglutide administered subcutaneously once daily for 12 consecutive months<br>* Other names: Victoza;|

What is the study measuring?
-----------------
Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change in Epicardial Fat Thickness | Epicardial fat thickness measured in mm via ultrasound | Baseline, 12 months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change in serum immunoglobulins | Immunoglobin levels assessed in g/L will be evaluated using serum blood samples | Baseline, 12 months | 
| Change in plasma ceramide levels | Plasma ceramide levels will be evaluated in umol/L | Baseline, 12 months |