Liraglutide for Low-responders After Bariatric Surgery

Obesity Clinical Trial

— LIBAR  

Official title:

Liraglutide for Low-responders After Bariatric Surgery

Clinical Trial Details — Status: Withdrawn

Administrative data

• NCT number: NCT04643301
• Other study ID #: NOK0020
• Status: Withdrawn
• Phase: N/A
• Start date: December 21, 2020
• Est. completion date: December 31, 2021

Study information

• Verified date: April 2021
• Source: Zuyderland Medisch Centrum
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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

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.

Recruitment information / eligibility

• Status: Withdrawn
• Enrollment: 0
• Est. completion date: December 31, 2021
• Est. primary completion date: December 31, 2021
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 75 Years

Eligibility

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

Related Conditions & MeSH terms

• Obesity
• Obesity, Morbid

Intervention

Drug:
• Liraglutide Pen Injector
Daily subcutaneous injection of 3.0mg liraglutide (GLP-1 antagonist) for low-responders 3 months after bariatric surgery.

Locations

Country	Name	City	State
n/a

Sponsors (2)

Lead Sponsor	Collaborator
Zuyderland Medisch Centrum	Nederlandse Obesitas Kliniek

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	%TWL (%TWL)	To study of the effect of six months treatment with Liraglutide (3.0 mg daily) on 9-month weight loss (%TWL) in low responders after bariatric surgery.	6 months
Secondary	Persistence	To describe the persistence of therapy. Number and percentage of patients who are able to tolerate the treatment throughout the study.	6 months
Secondary	GI symptoms	To describe the gastro-intestinal symptoms of the study group. Gastro-intestinal symptoms and eating habits of the patients will be assessed in two ways, first by adverse event rapportage and second with the "eating habits and physical problems" scales of the BODY-Q questionnaire (see F1 questionnaire) which will be administered at study start and at 14 weeks after study start.	6 months
Secondary	%TWL	To study the weight change at 12, 18, 24 and 36 months after surgery	12, 18, 24 and 36 months
Secondary	Dosage in mg	To describe the average daily dose patients use: Number and percentage of patients in whom dose escalation was according to protocol.; Number and percentage of patients who used 3.0 mg as a daily dose for 22 weeks.; Average daily dose of all patients (after the dose escalation)	6 months
Secondary	Eating habits	To describe the eating habits of the study group. Gastro-intestinal symptoms and eating habits of the patients will be assessed in two ways, first by adverse event rapportage and second with the "eating habits and physical problems" scales of the BODY-Q questionnaire (see F1 questionnaire) which will be administered at study start and at 14 weeks after study start.	6 months