Study of Semaglutide for Weight Loss in Obesity Patients with Low Response After Bariatric Surgery

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What is this study about?

This clinical trial is focused on studying obesity in individuals who have undergone weight-loss surgery, known as bariatric surgery. The study will use a medication called Semaglutide, which is given as an injection. The purpose of the study is to observe changes in weight from 3 to 18 months after surgery in patients who have not lost as much weight as expected. These patients will receive Semaglutide along with lifestyle guidance, and their progress will be compared to those receiving a placebo and lifestyle guidance.

Participants in the study will receive Semaglutide injections and follow a lifestyle program. The study will last for about 68 weeks, during which time participants’ weight and other health factors will be monitored. The main focus is on the percentage of total weight loss over this period. Additionally, the study will look at other health aspects such as metabolic health, which includes factors like blood pressure and cholesterol levels, as well as quality of life and any gastrointestinal symptoms.

Throughout the study, participants will have regular check-ups to measure their body weight, body mass index (BMI), and other health indicators. These check-ups will help researchers understand how Semaglutide affects weight loss and overall health after bariatric surgery. The study aims to provide insights into the effectiveness of Semaglutide in helping patients achieve better weight loss results and improve their health following surgery.

1 start of study

The study begins 3 months after bariatric surgery. At this point, the patient is identified as a low responder based on the percentage of total weight loss (%TWL).

The patient will start treatment with semaglutide 2.4 mg, which is a solution for injection. This medication is administered once a week.

2 initial assessments

Before starting the medication, several health parameters are assessed. These include body weight, body mass index (BMI), waist circumference, and waist/hip ratio.

Metabolic health is evaluated by measuring blood pressure, blood sugar levels (HbA1c and glucose), and cholesterol levels (triglycerides, LDL, HDL, and total cholesterol).

Gastro-intestinal symptoms and eating habits are assessed using a questionnaire. Quality of life is also evaluated using the same questionnaire.

3 treatment phase

The patient receives semaglutide injections weekly for a total of 68 weeks. The dose may be adjusted according to the protocol.

During this period, the patient also participates in a lifestyle intervention program.

4 follow-up assessments

Follow-up assessments occur at 3, 6, 12, and 18 months after surgery. These include measurements of body weight, BMI, waist circumference, and waist/hip ratio.

Metabolic health parameters are reassessed at each follow-up to monitor any changes or improvements.

Gastro-intestinal symptoms, eating habits, and quality of life are evaluated again using the questionnaire.

5 cardiorespiratory fitness assessment

Cardiorespiratory fitness is assessed using the Åstrand test, which involves cycling on a stationary bike for 6 minutes at a submaximal level. This test is conducted before surgery and at 3, 6, 12, and 18 months after surgery.

6 liver health assessment

Liver fat and liver stiffness are measured at the start of the study and after 68 weeks of semaglutide treatment using a method called vibration controlled transient elastography.

7 end of study

The study concludes 18 months after surgery. The main goal is to evaluate the change in %TWL from 3 to 18 months after surgery.

Secondary outcomes include changes in metabolic health, quality of life, gastro-intestinal symptoms, cardiorespiratory fitness, and liver health.

Who Can Join the Study?

The patient must be at least 18 years old and younger than 75 years old.
The patient’s BMI (Body Mass Index) before surgery must have been 35.0 kg/m² or higher. BMI is a measure that uses height and weight to estimate body fat.
The patient must be receiving group consultation at the Dutch Obesity Clinic (DOC).
The patient must have had a primary (banded) RYGB or (banded) sleeve gastrectomy (SG). RYGB stands for Roux-en-Y gastric bypass, and sleeve gastrectomy is a type of weight-loss surgery.
The patient must be in the lowest quartile for %TWL (percent total weight loss) three months after surgery and will be enrolled in the plus module. This means the patient is among those who lost the least weight compared to others in the study.

Who Cannot Join the Study?

Patients who have not undergone bariatric surgery cannot participate. Bariatric surgery is a type of surgery that helps with weight loss by making changes to the digestive system.
Patients who are not considered low responders after bariatric surgery are excluded. Low responders are individuals who do not lose as much weight as expected after the surgery.
Patients who are not willing to follow a lifestyle intervention program cannot join. A lifestyle intervention program includes changes in diet and physical activity to help with weight loss.
Patients who are not able to take the study medication, Semaglutide, are excluded. Semaglutide is a medication used to help with weight loss.
Patients who are not within the specified age range for the study cannot participate. The study is open to adults.
Patients who are part of a vulnerable population are not eligible. Vulnerable populations include groups who may have difficulty giving informed consent or are at higher risk of harm.

Where you can join this trial?

Verified and Recommended Sites

No sites found in this category

Verified Sites

Site Name	City	Country	Status
Zuyderland Medisch Centrum Stichting	Geleen	The Netherlands

Other Sites

Site Name	City	Country	Status
St. Antonius Ziekenhuis	Nieuwegein	The Netherlands
Rode Kruis Ziekenhuis B.V.	Beverwijk	The Netherlands

Trial status

Country	Status	Recruitment Start
The Netherlands	Recruiting	04.12.2023

Trial locations

Investigated drugs:

Semaglutide

Semaglutide is a medication used in this trial to help with weight loss. It is given to patients who have had bariatric surgery but did not lose as much weight as expected. The medication works by helping to control appetite and reduce food intake, which can lead to weight loss.

Lifestyle Intervention is a program included in the trial that focuses on helping patients make changes to their daily habits. This can include guidance on healthy eating, physical activity, and other behaviors that support weight loss and overall health. The goal is to help patients maintain a healthy weight after surgery.

Investigated diseases:

Obesity

Obesity – Obesity is a condition characterized by excessive body fat accumulation that may negatively impact health. It develops when calorie intake consistently exceeds calorie expenditure, leading to weight gain. Over time, this can result in increased body mass index (BMI) and may contribute to various health issues. The progression of obesity can lead to complications such as metabolic disorders, cardiovascular problems, and joint issues. It is often associated with lifestyle factors, including diet and physical activity levels. Obesity can also be influenced by genetic, environmental, and psychological factors.

Trial ID:

2022-502164-20-01

Protocol code:

NOK0024 / Z2023097

Trial Phase:

Therapeutic confirmatory (Phase III)

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Study of Semaglutide for Weight Loss in Obesity Patients with Low Response After Bariatric Surgery

What is this study about?

Who Can Join the Study?

Who Cannot Join the Study?