Pretreatment of patients expecting bariatric surgery with the GLP-1- Analogon Liraglutid

Phase 4

Recruiting

Conditions: E66.82
E11.90

Registration Number: DRKS00004203

Lead Sponsor: niversitätsklinikum Hamburg-Eppendorf

Brief Summary: Not available

Detailed Description: Not available

Recruitment & Eligibility

Status: Recruiting

Sex: All

Target Recruitment: 46

Inclusion Criteria

1. Signed and dated informed consent obtained before any trial-related activities or procedures
2.BMI of 35 – 50 kg/m²
3.Fasting blood glucose > 140 mg / dL
4.Diabetes mellitus type 2
5.Oral antidiabetic treatment with Metformin and/or Sulfonylurea before and during the trial
6.Scheduled for bariatric surgery

Exclusion Criteria

1.Contraindication for liraglutide treatment as defined in the Summary of Product Characteristics (SmPC)
2.Suspected or known hypersensitivity to liraglutide or any of its components
3.Women of childbearing potential who are either breastfeeding, pregnant or not using a medically acceptable method of birth control
4.Treatment with DPP IV inhibitors or GLP-1 analogues within the last three months
5.Treatment with Insulin
6.Pre-treatment with Liraglutide
7.Type 1 diabetes mellitus
8.HbA1c > 10 %

9.Serious thyroid dysfunction (ft4 > 2 times normal value)
10.Heart insufficiency (NYHA 3 – 4)
11.Renal failure (GFR < 50 L/min)
12.Suspected or known drug or alcohol abuse
13.Participation in another clinical trial

Study & Design

Study Type: interventional

Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
To compare body weight of patients with type 2 DM scheduled for weight loss surgery (RYGB) after 8 weeks of preoperative treatment with liraglutide to patients with type 2 DM treated with placebo

Secondary Outcome Measures

Name	Time	Method
Secondary objectives are the assessment of liver size (left liver lobe and right liver lobe)(Baseline compared to day of surgery), operative time, GLP-1 levels prior and post Operation (baseline, operation day, Day 1, day 2, day 3 after Operation) and the incidence and quantification of postoperative nausea and vomiting. Also the length of hospital stay and intraoperative complication rate will be analyzed. Furthermore to asses the change of body weight after a 8 week preoperative treatment phase at V2 and at 1, 2 and 3 days after surgery compared to preoperative weight at V1