iraglutide for low-responders after bariatric surgery
Withdrawn
- Conditions
- obesitasbariatric surgeryObesity10017998
- Registration Number
- NL-OMON49525
- Lead Sponsor
- ederlandse Obesitas Kliniek
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Withdrawn
- Sex
- Not specified
- Target Recruitment
- 100
Inclusion Criteria
* Patient is *18 and <75 years old
* BMI before surgery was * 35.0 kg/m2
* Patient is treated with group consultation at the NOK
* Patient has undergone a primary Roux-en-Y gastric bypass (RYGB) or sleeve
gastrectomy (SG)
* Patient is in the lowest %TWL quartile, 3 months after surgery and will be
enrolled in the plus module.
Exclusion Criteria
* Type 1 or type 2 diabetes
* Decreased renal function (creatinine clearance < 30 ml/min)
* Liver failure (all)
* Congestive heart failure or angina pectoris NYHA class III and IV
* Malignancy in history
* Pancreatitis (in history)
* Pregnancy / breast-feeding
* Inflammatory Bowel Disease
* Thyroid malignancy in history
* Use of warfarin or other coumarin derivates
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method <p>The primary objective is to study the effect of Liraglutide (3.0 mg daily) on<br /><br>9-month weight loss in low responders after bariatric surgery. </p><br>
- Secondary Outcome Measures
Name Time Method <p>There are three secondary objectives:<br /><br>a) To describe the persistence of therapy and the average daily dose patients<br /><br>used<br /><br>b) To describe the gastro-intestinal symptoms and eating habits of the study<br /><br>group<br /><br>c) To study the weight loss up to 36 months after surgery</p><br>