Antigen-Lipid-Driven Monoclonal Gammopathies Targeting Epicardial Fat
Primary Purpose
Monoclonal Gammopathies, Overweight, Obesity
Status
Withdrawn
Phase
Phase 4
Locations
Study Type
Interventional
Intervention
Liraglutide
Sponsored by
About this trial
This is an interventional treatment trial for Monoclonal Gammopathies
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
Sites / Locations
Arms of the Study
Arm 1
Arm Type
Experimental
Arm Label
Liraglutide Group
Arm Description
Participants in this group will receive the Liraglutide intervention for 12 months
Outcomes
Primary Outcome Measures
Change in Epicardial Fat Thickness
Epicardial fat thickness measured in mm via ultrasound
Secondary Outcome Measures
Change in serum immunoglobulins
Immunoglobin levels assessed in g/L will be evaluated using serum blood samples
Change in plasma ceramide levels
Plasma ceramide levels will be evaluated in umol/L
Full Information
NCT ID
NCT02920190
First Posted
August 22, 2016
Last Updated
September 17, 2020
Sponsor
University of Miami
1. Study Identification
Unique Protocol Identification Number
NCT02920190
Brief Title
Antigen-Lipid-Driven Monoclonal Gammopathies Targeting Epicardial Fat
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)
Study Type
Interventional
2. Study Status
Record Verification Date
September 2020
Overall Recruitment Status
Withdrawn
Why Stopped
Lack of funds to cover the costs of the study medications
Study Start Date
September 1, 2020 (Anticipated)
Primary Completion Date
September 1, 2021 (Anticipated)
Study Completion Date
December 31, 2021 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
University of Miami
4. Oversight
Studies a U.S. FDA-regulated Drug Product
Yes
Studies a U.S. FDA-regulated Device Product
No
Product Manufactured in and Exported from the U.S.
No
Data Monitoring Committee
No
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Monoclonal Gammopathies, Overweight, Obesity
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 4
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
0 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Liraglutide Group
Arm Type
Experimental
Arm Description
Participants in this group will receive the Liraglutide intervention for 12 months
Intervention Type
Drug
Intervention Name(s)
Liraglutide
Other Intervention Name(s)
Victoza
Intervention Description
1.8 mg Liraglutide administered subcutaneously once daily for 12 consecutive months
Primary Outcome Measure Information:
Title
Change in Epicardial Fat Thickness
Description
Epicardial fat thickness measured in mm via ultrasound
Time Frame
Baseline, 12 months
Secondary Outcome Measure Information:
Title
Change in serum immunoglobulins
Description
Immunoglobin levels assessed in g/L will be evaluated using serum blood samples
Time Frame
Baseline, 12 months
Title
Change in plasma ceramide levels
Description
Plasma ceramide levels will be evaluated in umol/L
Time Frame
Baseline, 12 months
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
70 Years
Accepts Healthy Volunteers
No
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
James Hoffman, MD
Organizational Affiliation
University of Miami
Official's Role
Principal Investigator
12. IPD Sharing Statement
Plan to Share IPD
No
Learn more about this trial
Antigen-Lipid-Driven Monoclonal Gammopathies Targeting Epicardial Fat
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