Antigen-Lipid-Driven Monoclonal Gammopathies Targeting Ep... | NCT02920190

Studies
Antigen-Lipid-Driven Monoclonal Gammopathies Targeting Epicardial Fat

NCT02920190

Sponsor

University of Miami

Status

Withdrawn

Last Update Posted

Sep 21, 2020Actual

Enrollment

0Actual

Phase

Phase 4

Conditions

Monoclonal Gammopathies
Overweight
Obesity

Interventions

Liraglutide

Countries

Not provided

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Sep 2020

Overall Recruitment Status or Expanded Access Status

Withdrawn

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Lack of funds to cover the costs of the study medications

Expanded Access Info

Start Date

Sep 1, 2020Estimated

Primary Completion Date

Sep 1, 2021Estimated

Completion Date

Dec 31, 2021Estimated

First Submitted Date

Aug 22, 2016

First Submission Date that Met QC Criteria

Sep 28, 2016

First Posted Date

Sep 30, 2016Estimated

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Sep 17, 2020

Last Update Posted Date

Sep 21, 2020Actual

Oversight Module

Has Data Monitoring Committee (DMC)

Is FDA Regulated Drug

Yes

Is FDA Regulated Device

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

FDAAA801 Violation

Not provided

Design Module

Study Type

Interventional

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Not provided

Target Follow-Up Duration

Not provided

Phases

Phase 4

Interventional Study Design

Allocation

Biospecimen

No data available

No data is available for this block.

Enrollment

0Actual

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
Liraglutide Group	Experimental	Participants in this group will receive the Liraglutide intervention for 12 months	Drug: Liraglutide

Interventions

Name	Type	Description	Arm Group Labels	Other Names
Liraglutide	Drug	1.8 mg Liraglutide administered subcutaneously once daily for 12 consecutive months	Liraglutide Group

Outcomes Module

Primary Outcomes

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

Secondary Outcomes

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

Other Outcomes

Not provided

Eligibility Module

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

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

18 Years

Maximum Age

70 Years

Standard Ages

AdultOlder Adult

Study Population

Not provided

Sampling Method

Not provided

Name	Affiliation	Role
James Hoffman, MD	University of Miami	Principal Investigator

IPD Sharing Statement Module

Plan to Share IPD

Description

Not provided

Types

Not provided

Time Frame

Not provided

Access Criteria

Not provided

URL

Not provided

Condition Browse Module

MeSH Terms

ID	Term
D010265	Paraproteinemias
D050177	Overweight
D009765	Obesity

Ancestor Terms

ID	Term
D001796	Blood Protein Disorders
D006402	Hematologic Diseases
D006425	Hemic and Lymphatic Diseases
D007160	Immunoproliferative Disorders

Browse Leaves

Not provided

Browse Branches

Not provided

Intervention Browse Module

MeSH Terms

ID	Term
D000069450	Liraglutide

Ancestor Terms

ID	Term
D052216	Glucagon-Like Peptide 1
D004763	Glucagon-Like Peptides
D052336	Proglucagon
D005768	Gastrointestinal Hormones

Browse Leaves

Not provided

Browse Branches

Not provided