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

Phase 3

Terminated

• Conditions: Obesity
• Interventions: Drug: GLP-1 (Liraglutide); Drug: Placebo

• Registration Number: NCT02417103
• Lead Sponsor: Universitätsklinikum Hamburg-Eppendorf

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

Study Timeline

• Study Start: 2011-12
• Study First Submitted: 2015-04-10
• Study First Submitted QC: 2015-04-14
• Study First Posted: 2015-04-15
• Primary Completion: 2016-09
• Study Completion: 2016-12
• Status Verified: 2022-06
• Last Update Submitted: 2022-06-29
• Last Update Posted: 2022-06-30

Recruitment & Eligibility

• Status: TERMINATED
• Sex: All
• Target Recruitment: 2

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%

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

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

Primary Outcome Measures

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

Secondary Outcome Measures

Name	Time	Method
GLP-1 Levels	4 years	Measurement of GLP-1 levels during the defined period

Trial Locations

Locations (1)

University Medical Center Hamburg; 🇩🇪 Hamburg, Germany