Antigen-Lipid-Driven Monoclonal Gammopathies Targeting Epicardial Fat
NCT ID: NCT02920190
Last Updated: 2020-09-21
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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WITHDRAWN
PHASE4
INTERVENTIONAL
2020-09-01
2021-12-31
Brief Summary
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Detailed Description
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Conditions
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Study Design
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NA
SINGLE_GROUP
TREATMENT
NONE
Study Groups
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Liraglutide Group
Participants in this group will receive the Liraglutide intervention for 12 months
Liraglutide
1.8 mg Liraglutide administered subcutaneously once daily for 12 consecutive months
Interventions
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Liraglutide
1.8 mg Liraglutide administered subcutaneously once daily for 12 consecutive months
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* 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
* 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
18 Years
70 Years
ALL
No
Sponsors
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University of Miami
OTHER
Responsible Party
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James Hoffman, MD
Assistant Professor
Principal Investigators
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James Hoffman, MD
Role: PRINCIPAL_INVESTIGATOR
University of Miami
Other Identifiers
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20160568
Identifier Type: -
Identifier Source: org_study_id
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