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

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

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.

Study Overview

• Status: Terminated
• Conditions: Obesity
• Intervention / Treatment: Drug: Placebo; Drug: GLP-1 (Liraglutide)

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 Type: Interventional
• Enrollment (Actual): 2
• Phase: Phase 3

Contacts and Locations

Study Locations

• Germany
  • Hamburg, Germany, 20246
    • University Medical Center Hamburg

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 77 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Double

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Active Comparator: GLP-1 (Liraglutide); 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); GLP-1 Analogon; Other Names: Victoza
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; Placebo; Other Names: PL1 PR1

What is the study measuring?

Primary Outcome Measures

Outcome Measure	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 Outcome Measures

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

Collaborators and Investigators

• Sponsor: Universitätsklinikum Hamburg-Eppendorf
• Investigators: Principal Investigator: Jens Aberle, MD, Universitatsklinikum Hamburg-Eppendorf

Study record dates

Study Major Dates

• Study Start: December 1, 2011
• Primary Completion (Actual): September 1, 2016
• Study Completion (Actual): December 1, 2016

Study Registration Dates

• First Submitted: April 10, 2015
• First Submitted That Met QC Criteria: April 14, 2015
• First Posted (Estimate): April 15, 2015

Study Record Updates

• Last Update Posted (Actual): June 30, 2022
• Last Update Submitted That Met QC Criteria: June 29, 2022
• Last Verified: June 1, 2022

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Hypoglycemic Agents; Physiological Effects of Drugs; Hormones; Hormones, Hormone Substitutes, and Hormone Antagonists; Incretins; Liraglutide
• Other Study ID Numbers: GLP1Bariatric