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

Obesity Clinical Trial

Official title:

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

Clinical Trial Details — Status: Terminated

Administrative data

• NCT number: NCT02417103
• Other study ID #: GLP1Bariatric
• Status: Terminated
• Phase: Phase 3
• Start date: December 2011
• Est. completion date: December 2016

Study information

• Verified date: June 2022
• Source: Universitätsklinikum Hamburg-Eppendorf
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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

Recruitment information / eligibility

• Status: Terminated
• Enrollment: 2
• Est. completion date: December 2016
• Est. primary completion date: September 2016
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 77 Years

Eligibility

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%

Related Conditions & MeSH terms

• Obesity

Intervention

Drug:
• GLP-1 (Liraglutide)
GLP-1 Analogon
• Placebo
Placebo

Locations

Country	Name	City	State
Germany	University Medical Center Hamburg	Hamburg

Sponsors (1)

Lead Sponsor	Collaborator
Universitätsklinikum Hamburg-Eppendorf

Country where clinical trial is conducted

Germany, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	GLP-1 Levels	Measurement of GLP-1 levels during the defined period	4 years