Pretreatment of Patients Expecting Bariatric Surgery With... | NCT02417103

Studies
Pretreatment of Patients Expecting Bariatric Surgery With the GLP-1 Analogon Liraglutid

NCT02417103

Sponsor

Universitätsklinikum Hamburg-Eppendorf

Status

Terminated

Last Update Posted

Jun 30, 2022Actual

Enrollment

2Actual

Phase

Phase 3

Conditions

Obesity

Interventions

GLP-1 (Liraglutide)
Placebo

Countries

Germany

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

Annotation Module

Unposted Annotation

Unposted Responsible Party

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Jun 2022

Overall Recruitment Status or Expanded Access Status

Terminated

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Recruiting failure

Expanded Access Info

Start Date

Dec 2011

Primary Completion Date

Sep 2016Actual

Completion Date

Dec 2016Actual

First Submitted Date

Apr 10, 2015

First Submission Date that Met QC Criteria

Apr 14, 2015

First Posted Date

Apr 15, 2015Estimated

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

Jun 29, 2022

Last Update Posted Date

Jun 30, 2022Actual

Oversight Module

Has Data Monitoring Committee (DMC)

Is FDA Regulated Drug

Not provided

Is FDA Regulated Device

Not provided

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

Brief Summary

The aim of this study is to investigate the effect of the treatment with the GLP-1 Analogon Liraglutide on the lipid metabolism an inflammation in adipose tissue.

Detailed Description

The aim of this study is to investigate the effect of the treatment with the GLP-1 Analogon Liraglutide on the lipid metabolism an inflammation in adipose tissue. As GLP-1 is presumed to improve insulin sensitivity and associated parameters the investigators hypothesize that this might be due to changes in lipid metabolism which might be involved in the regulation of insulin sensitivity. Therefore the investigators intend to investigate changes of metabolic pathways before and after treatment with the GLP-1 analog liraglutide that could play a crucial role in pathogenesis as well as regulation of insulin sensitivity and atherogenic dyslipidemia such as: de novo lipogenesis and reverse cholesterol transport

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 3

Interventional Study Design

Allocation

Biospecimen

No data available

No data is available for this block.

Enrollment

2Actual

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
GLP-1 (Liraglutide)	Active Comparator	Daily subcutaneous injection of Lirglutide over 9 weeks prior to bariatric surgery with a dosing of 0,6-1,8 mg	Drug: GLP-1 (Liraglutide)
Placebo Comparator	Placebo Comparator	Daily subcutaneous injection of PL1/PR1 Placebo over 9 weeks prior to bariatric surgery with a dosing of 0,6-1,8 mg	Drug: Placebo

Interventions

Name	Type	Description	Arm Group Labels	Other Names
GLP-1 (Liraglutide)	Drug	GLP-1 Analogon	GLP-1 (Liraglutide)	Victoza

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
weight reduction	to compare body weight with type 2 Diabetes scheduled for weight loss surgery after 8 weeks of preoperative treatment with either placebo or liragludite	4 years

Secondary Outcomes

Measure	Description	Time Frame
GLP-1 Levels	Measurement of GLP-1 levels during the defined period	4 years

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

BMI 35-55 Kg/m2
Fasting Blood glucose >140mg/dl
Planned bariatric surgery
Diabetic Medication (Metformin, Sulfonylurea, Insuline)

Exclusion Criteria:

Known hypersensitivity against Liraglutid
Pretreatment DPP-4 Inhibitors or GLP-1 Analogue the last 3 months
HbA1c >10%

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

18 Years

Maximum Age

77 Years

Standard Ages

AdultOlder Adult

Study Population

Not provided

Sampling Method

Not provided

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Name	Affiliation	Role
Jens Aberle, MD	Universitätsklinikum Hamburg-Eppendorf	Principal Investigator

Locations

Facility	Status	City	State	ZIP	Country	Contacts
University Medical Center Hamburg		Hamburg		20246	Germany

Type	Date	Date Unknown
Release	Jul 14, 2022
Reset	May 25, 2023

Release Date	Unrelease Date	Unrelease Date Unknown	Reset Date	MCP Release Number
Jul 14, 2022			May 25, 2023

Condition Browse Module

MeSH Terms

ID	Term
D009765	Obesity

Ancestor Terms

ID	Term
D050177	Overweight
D044343	Overnutrition
D009748	Nutrition Disorders
D009750	Nutritional and Metabolic Diseases

Browse Leaves

Not provided

Browse Branches

Not provided

Intervention Browse Module

MeSH Terms

ID	Term
D052216	Glucagon-Like Peptide 1
D000069450	Liraglutide

Ancestor Terms

ID	Term
D004763	Glucagon-Like Peptides
D052336	Proglucagon
D005768	Gastrointestinal Hormones
D006728	Hormones

Browse Leaves

Not provided

Browse Branches

Not provided