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

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

Status
Terminated
Phases
Phase 3
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT02417103
Enrollment
2
Registered
2015-04-15
Start date
2011-12-31
Completion date
2016-12-31
Last updated
2022-06-30

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Obesity

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

Interventions

DRUGGLP-1 (Liraglutide)

GLP-1 Analogon

DRUGPlacebo

Placebo

Sponsors

Universitätsklinikum Hamburg-Eppendorf
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
DOUBLE (Subject, Caregiver)

Eligibility

Sex/Gender
ALL
Age
18 Years to 77 Years
Healthy volunteers
No

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%

Design outcomes

Primary

MeasureTime frameDescription
weight reduction4 yearsto compare body weight with type 2 Diabetes scheduled for weight loss surgery after 8 weeks of preoperative treatment with either placebo or liragludite

Secondary

MeasureTime frameDescription
GLP-1 Levels4 yearsMeasurement of GLP-1 levels during the defined period

Countries

Germany

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026