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

NCT ID: NCT02417103

Last Updated: 2022-06-30

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

TERMINATED

Clinical Phase

PHASE3

Total Enrollment

2 participants

Study Classification

INTERVENTIONAL

Study Start Date

2011-12-31

Study Completion Date

2016-12-31

Brief Summary

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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

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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

Conditions

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Obesity

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

DOUBLE

Participants Caregivers

Study Groups

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GLP-1 (Liraglutide)

Daily subcutaneous injection of Lirglutide over 9 weeks prior to bariatric surgery with a dosing of 0,6-1,8 mg

Group Type ACTIVE_COMPARATOR

GLP-1 (Liraglutide)

Intervention Type DRUG

GLP-1 Analogon

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

Group Type PLACEBO_COMPARATOR

Placebo

Intervention Type DRUG

Placebo

Interventions

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GLP-1 (Liraglutide)

GLP-1 Analogon

Intervention Type DRUG

Placebo

Placebo

Intervention Type DRUG

Other Intervention Names

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Victoza PL1 PR1

Eligibility Criteria

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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%
Minimum Eligible Age

18 Years

Maximum Eligible Age

77 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Universitätsklinikum Hamburg-Eppendorf

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Jens Aberle, MD

Role: PRINCIPAL_INVESTIGATOR

Universitätsklinikum Hamburg-Eppendorf

Locations

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University Medical Center Hamburg

Hamburg, , Germany

Site Status

Countries

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Germany

Other Identifiers

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GLP1Bariatric

Identifier Type: -

Identifier Source: org_study_id

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