Clinical trial NCT04643301: Liraglutide for Low-responders After Bariatric Surgery
Official title: Liraglutide for Low-responders After Bariatric Surgery
Study type: INTERVENTIONAL
Overall status: WITHDRAWN
Phase: NA
Conditions: Obesity
Obesity, Morbid
Keywords: Obesity
Liraglutide
GLP-1
Bariatric Surgery
Weight loss
Low-responders
Lead sponsor: Zuyderland Medisch Centrum
Sponsor class: OTHER
Collaborators: name: Nederlandse Obesitas Kliniek
First posted: 2020-11-25
Enrollment: 0
Sex: ALL
Minimum age (years): 18
Maximum age (years): 75
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Intervention model description: The study cohort will be compared to a retrospective matched cohort based on BMI before surgery, gender and type of surgery
Primary purpose: OTHER

Brief summary: To study the effect of Liraglutide (3.0 mg daily) on 9-month weight loss in low responders 3-months after bariatric surgery.

Detailed description: Rationale: In 20 - 30% of the patients sufficient weight loss is not achieved (low responders) after bariatric surgery. Secondary and/or tertiary bariatric procedures can lead to successful weight loss and resolution of comorbid conditions though, morbidity and mortality rates of these procedures are high. Therefore, additional pharmacotherapy has been suggested. Liraglutide is one of the medications that might improve outcome in the post-bariatric population. It is a Glucagon-like peptide-1 receptor analogue developed to treat type 2 diabetes which 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.

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.

Study population: Bariatric patients with a pre-operative BMI ≥ 35.0 kg/m2 who have undergone a primary Roux-en-Y gastric bypass or sleeve gastrectomy, are treated with group consultations by the Nederlandse Obesitas Kliniek and are low responders at 3-months follow-up for which they will be treated with the plus module. A low responder is defined by comparing the measured percentage total weight loss (%TWL) at the 3-month follow-up with the expected weight loss. When %TWL is below the 25% quartile of expected weight loss the patient is considered a low responder. The plus module is an extra intervention our clinic provides for the patients who are considered low responders at the 3-month follow-up moment after surgery, this is part of our standard care program.

Intervention: Addition of Liraglutide 3.0 mg daily for 6 months to standard care.

Main study parameters/endpoints: 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. The secondary objectives are the description of persistence of therapy and used daily dose, gastro-intestinal symptoms and eating habits and weight loss up to 36 months after surgery.

Nature and extent of the burden and risks associated with participation, benefit and group relatedness: The burden of participation consists of extra usage of medication which patients have to administer subcutaneously daily, the extra consultations and two questionnaires. The risks consist of the mainly gastro-intestinal side-effects.

Eligibility criteria: Inclusion Criteria:

* 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

Primary outcomes:
measure: %TWL (%TWL)
timeFrame: 6 months
Secondary outcomes:
measure: Persistence
timeFrame: 6 months
measure: GI symptoms
timeFrame: 6 months
measure: %TWL
timeFrame: 12, 18, 24 and 36 months
measure: Dosage in mg
timeFrame: 6 months
measure: Eating habits
timeFrame: 6 months
Other outcomes:
Locations:
Study officials:
affiliation: Nederlandse Obesitas Kliniek/Zuyderland Medisch Centrum
name: J.W. Greve, MD, PHD
role: PRINCIPAL_INVESTIGATOR
References: