Pretreatment of patients with Type 2 diabetes mellitus with expected weight loss surgery (Roux-en-Y Gastric Bypass) MedDRA version: 14.1 Level: PT Classification code 10012601 Term: Diabetes mellitus System Organ Class: 10027433 - Metabolism and nutrition disorders
Conditions
Interventions
Trade Name: Victoza®
Pharmaceutical Form: Injection
INN or Proposed INN: LIRAGLUTIDE
CAS Number: 204656-20-2
Concentration unit: mg/ml milligram(s)/millilitre
Concentration type: equal
Concentration n
Sponsors
University Medical Center Hamburg-Eppendorf
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: 1. Signed and dated informed consent obtained before any trial-related activities or procedures 2. Male or female 3. Aged 18 - 70 years 4. BMI of 35 – 50 kg/m² 5. Fasting blood glucose > 140 mg / dL 6. Diabetes mellitus type 2 7. Oral antidiabetic treatment 8. Scheduled for bariatric surgery Are the trial subjects under 18? no Number of subjects for this age range: F.1.2 Adults (18-64 years) yes F.1.2.1 Number of subjects for this age range 41 F.1.3 Elderly (>=65 years) yes F.1.3.1 Number of subjects for this age range 5
Exclusion criteria
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. Serious thyroid dysfunction (ft4 > 2 times normal value) 9. Heart insufficiency (NYHA 3 – 4) 10. Renal failure (GFR < 50 L/min) 11. Suspected or known drug or alcohol abuse 12. Participation in another clinical trial 13. Any condition which in the opinion of the investigator makes the patient unsuitable for inclusion
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: 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 Objective: To asses liver size (right and left liver lobe), operative time, GLP-1 levels prior and post 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 assess change of body weight after a 8 week preoperative treatment at 1, 2 and 3 days after surgery;Primary end point(s): - Weight prior to surgery ;Timepoint(s) of evaluation of this end point: Visit 2 | — |
Secondary
| Measure | Time frame |
|---|---|
| Secondary end point(s): - 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 - Change in Liver size (right-, and left liver lobe) as assessed by ultrasound at V1 and after 8 weeks of Liraglutide application prior to surgery at V2 - Operative time defined as time between section and suture - Quantification of intraoperative complications - Pre and post operative GLP – 1 levels - Quantification of postoperative vomiting - Extend of postoperative nausea as assessed by patient’s perception - Postoperative nausea and vomiting as assessed by questionnaires 1, 2, 3 days post surgery and at discharge - Duration of hospitalization ;Timepoint(s) of evaluation of this end point: see above | — |
Countries
Germany
Contacts
Public ContactPrincipal Investigator
University Medical Center Hamburg-Eppendorf
Outcome results
None listed