To study the effect of Liraglutide (3.0 mg daily) on 9-month weight loss in low responders 3-months after bariatric surgery.
ID
Source
Brief title
Condition
- Other condition
- Gastrointestinal therapeutic procedures
Synonym
Health condition
obesitas
Research involving
Sponsors and support
Intervention
Outcome measures
Primary outcome
The primary objective is to study the effect of Liraglutide (3.0 mg daily) on
9-month weight loss in low responders after bariatric surgery.
Secondary outcome
There are three secondary objectives:
a) To describe the persistence of therapy and the average daily dose patients
used
b) To describe the gastro-intestinal symptoms and eating habits of the study
group
c) To study the weight loss up to 36 months after surgery
Background summary
Compared to life-style intervention programs, bariatric surgery has proven to
be a superior treatment for morbid obesity. However, in 20 * 30% of the
patients sufficient weight loss is not achieved (low responders) or weight
regain occurs. Secondary and/or tertiary bariatric procedures can lead to
successful weight loss and resolution of comorbid conditions, however morbidity
and mortality rates of these procedures are high. Therefore, additional
pharmacotherapy in post-bariatric patients has been suggested. Liraglutide is
one of the medications that might improve outcome in the post-bariatric
population.
Liraglutide is a Glucagon-like peptide-1 (GLP-1) receptor analogue developed to
treat type 2 diabetes. It causes glucose-dependent insulin secretion and
promotes satiety and inhibits glucagon secretion. In obese (non-bariatric)
patients, Liraglutide has shown to improve glycemic control, decrease blood
pressure, lower cardiovascular risk and decrease body weight.
There are only a few small retrospective trials assessing the effect of
additional pharmacotherapy in low responders after bariatric surgery. These
trials show promising results, with weight loss up to 9.7 % and limited
side-effects.
Study objective
To study the effect of Liraglutide (3.0 mg daily) on 9-month weight loss in low
responders 3-months after bariatric surgery.
Study design
Pragmatic trial.
Intervention
Addition of Liraglutide 3.0 mg daily for 6 months to standard care.
Study burden and risks
The burden of participation consists of extra usage of medication which
patients have to administer subcutaneously daily, the extra consultations and
questionnaires. The risk consists of side-effects, of which we think
gastro-intestinal side-effects will be most frequent.
Amersfoortseweg 43
Huis ter Heide 3812 BA
NL
Amersfoortseweg 43
Huis ter Heide 3812 BA
NL
Listed location countries
Age
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
Design
Recruitment
Medical products/devices used
Followed up by the following (possibly more current) registration
No registrations found.
Other (possibly less up-to-date) registrations in this register
No registrations found.
In other registers
| Register | ID |
|---|---|
| EudraCT | EUCTR2020-000548-71-NL |
| CCMO | NL73067.096.20 |