Antigen-Lipid-Driven Monoclonal Gammopathies Targeting Epicardial Fat

Obesity Clinical Trial

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)

Clinical Trial Details — Status: Withdrawn

Administrative data

• NCT number: NCT02920190
• Other study ID #: 20160568
• Status: Withdrawn
• Phase: Phase 4
• Start date: September 1, 2020
• Est. completion date: December 31, 2021

Study information

• Verified date: September 2020
• Source: University of Miami
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Withdrawn
• Enrollment: 0
• Est. completion date: December 31, 2021
• Est. primary completion date: September 1, 2021
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 70 Years

Eligibility

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

Related Conditions & MeSH terms

• Monoclonal Gammopathies
• Monoclonal Gammopathy of Undetermined Significance
• Obesity
• Overweight
• Paraproteinemias

Intervention

Drug:
• Liraglutide
1.8 mg Liraglutide administered subcutaneously once daily for 12 consecutive months

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
University of Miami

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Change in Epicardial Fat Thickness	Epicardial fat thickness measured in mm via ultrasound	Baseline, 12 months
Secondary	Change in serum immunoglobulins	Immunoglobin levels assessed in g/L will be evaluated using serum blood samples	Baseline, 12 months
Secondary	Change in plasma ceramide levels	Plasma ceramide levels will be evaluated in umol/L	Baseline, 12 months