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NCT02417103 Clinical Trial

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
Secondary ID
Status Terminated
Phase Phase 3
First received
Last updated
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
Health authority
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%

Study Design

Related Conditions & MeSH terms

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
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