Liraglutide for Low-responders After Bariatric Surgery (LIBAR)

April 22, 2021 updated by: Zuyderland Medisch Centrum
To study the effect of Liraglutide (3.0 mg daily) on 9-month weight loss in low responders 3-months after bariatric surgery.

Study Overview

Status

Withdrawn

Conditions

Intervention / Treatment

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.

Study Type

Interventional

Phase

  • Not Applicable

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

16 years to 73 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Other
  • Allocation: N/A
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Adding Liraglutide to current treatment program
Adding 3,0mg of Liraglutide to the current treatment program of low-responders 3 months after bariatric surgery.
Drug: Liraglutide Pen Injector
Daily subcutaneous injection of 3.0mg liraglutide (GLP-1 antagonist) for low-responders 3 months after bariatric surgery.
Other Names:
  • Saxenda

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
%TWL (%TWL)
Time Frame: 6 months
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 Outcome Measures

Outcome Measure
Measure Description
Time Frame
Persistence
Time Frame: 6 months
To describe the persistence of therapy. Number and percentage of patients who are able to tolerate the treatment throughout the study.
6 months
GI symptoms
Time Frame: 6 months
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
%TWL
Time Frame: 12, 18, 24 and 36 months
To study the weight change at 12, 18, 24 and 36 months after surgery
12, 18, 24 and 36 months
Dosage in mg
Time Frame: 6 months

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
Eating habits
Time Frame: 6 months
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

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Zuyderland Medisch Centrum

Collaborators

Nederlandse Obesitas Kliniek

Investigators

  • Principal Investigator: J.W. Greve, MD, PHD, Nederlandse Obesitas Kliniek/Zuyderland Medisch Centrum

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Anticipated)

December 21, 2020

Primary Completion (Anticipated)

December 31, 2021

Study Completion (Anticipated)

December 31, 2021

Study Registration Dates

First Submitted

November 2, 2020

First Submitted That Met QC Criteria

November 18, 2020

First Posted (Actual)

November 25, 2020

Study Record Updates

Last Update Posted (Actual)

April 26, 2021

Last Update Submitted That Met QC Criteria

April 22, 2021

Last Verified

April 1, 2021

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • NOK0020

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

Undecided

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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