Clinical Trials Logo

Clinical Trial Details — Status: Withdrawn

Administrative data

NCT number NCT04643301
Other study ID # NOK0020
Secondary ID
Status Withdrawn
Phase N/A
First received
Last updated
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
Health authority
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

Study Design


Related Conditions & MeSH terms


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
See also
  Status Clinical Trial Phase
Recruiting NCT04101669 - EndoBarrier System Pivotal Trial(Rev E v2) N/A
Recruiting NCT04243317 - Feasibility of a Sleep Improvement Intervention for Weight Loss and Its Maintenance in Sleep Impaired Obese Adults N/A
Terminated NCT03772886 - Reducing Cesarean Delivery Rate in Obese Patients Using the Peanut Ball N/A
Completed NCT03640442 - Modified Ramped Position for Intubation of Obese Females. N/A
Completed NCT04506996 - Monday-Focused Tailored Rapid Interactive Mobile Messaging for Weight Management 2 N/A
Recruiting NCT06019832 - Analysis of Stem and Non-Stem Tibial Component N/A
Active, not recruiting NCT05891834 - Study of INV-202 in Patients With Obesity and Metabolic Syndrome Phase 2
Active, not recruiting NCT05275959 - Beijing (Peking)---Myopia and Obesity Comorbidity Intervention (BMOCI) N/A
Recruiting NCT04575194 - Study of the Cardiometabolic Effects of Obesity Pharmacotherapy Phase 4
Completed NCT04513769 - Nutritious Eating With Soul at Rare Variety Cafe N/A
Withdrawn NCT03042897 - Exercise and Diet Intervention in Promoting Weight Loss in Obese Patients With Stage I Endometrial Cancer N/A
Completed NCT03644524 - Heat Therapy and Cardiometabolic Health in Obese Women N/A
Recruiting NCT05917873 - Metabolic Effects of Four-week Lactate-ketone Ester Supplementation N/A
Active, not recruiting NCT04353258 - Research Intervention to Support Healthy Eating and Exercise N/A
Completed NCT04507867 - Effect of a NSS to Reduce Complications in Patients With Covid-19 and Comorbidities in Stage III N/A
Recruiting NCT03227575 - Effects of Brisk Walking and Regular Intensity Exercise Interventions on Glycemic Control N/A
Completed NCT01870947 - Assisted Exercise in Obese Endometrial Cancer Patients N/A
Recruiting NCT06007404 - Understanding Metabolism and Inflammation Risks for Diabetes in Adolescents
Recruiting NCT05972564 - The Effect of SGLT2 Inhibition on Adipose Inflammation and Endothelial Function Phase 1/Phase 2
Recruiting NCT05371496 - Cardiac and Metabolic Effects of Semaglutide in Heart Failure With Preserved Ejection Fraction Phase 2