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

Universitätsklinikum Hamburg-Eppendorf

Status and phase: Terminated; Phase 3

Conditions: Obesity

Treatments: Drug: Placebo; Drug: GLP-1 (Liraglutide)

Study type: Interventional

Funder types: Other

Identifiers

NCT02417103

GLP1Bariatric

Details and patient eligibility

About

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.

Full 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

Enrollment: 2 patients

Sex: All

Ages: 18 to 77 years old

Volunteers: No Healthy Volunteers

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%

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Double Blind

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2 participants in 2 patient groups, including a placebo group

GLP-1 (Liraglutide)

Active Comparator group

Description:

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

Treatment:

Drug: GLP-1 (Liraglutide)

Placebo Comparator

Placebo Comparator group

Description:

Daily subcutaneous injection of PL1/PR1 Placebo over 9 weeks prior to bariatric surgery with a dosing of 0,6-1,8 mg

Treatment:

Drug: Placebo