Antigen-Lipid-Driven Monoclonal Gammopathies Targeting Epicardial Fat

NCT ID: NCT02920190

Last Updated: 2020-09-21

Study Results

Results pending

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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Recruitment Status

WITHDRAWN

Clinical Phase

PHASE4

Study Classification

INTERVENTIONAL

Study Start Date

2020-09-01

Study Completion Date

2021-12-31

Brief Summary

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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

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Conditions

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Monoclonal Gammopathies Overweight Obesity

Study Design

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Allocation Method

NA

Intervention Model

SINGLE_GROUP

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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Liraglutide Group

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

Group Type EXPERIMENTAL

Liraglutide

Intervention Type DRUG

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

Intervention Type DRUG

Other Intervention Names

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Victoza

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Maximum Eligible Age

70 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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University of Miami

OTHER

Sponsor Role lead

Responsible Party

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James Hoffman, MD

Assistant Professor

Responsibility Role PRINCIPAL_INVESTIGATOR

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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