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Clinical Trial NCT06287307 (SEABAR) for Obesity, Obesity, Morbid, Weight Gain is not yet recruiting. See the Trial Radar Card View and AI discovery tools for all the details. Or ask anything here. | ||
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Semaglutide 2.4mg for Low Responders After Bariatric Surgery (SEABAR) Phase 4 152
Clinical Trial NCT06287307 (SEABAR) is designed to study Treatment for Obesity, Obesity, Morbid, Weight Gain. This Phase 4 interventional study is not yet recruiting. Enrollment is planned to begin on May 1, 2024 until the study accrues 152 participants. Led by Zuyderland Medisch Centrum, this study is expected to complete by September 1, 2026. The latest data from ClinicalTrials.gov was last updated on March 1, 2024.
Brief Summary
In 20 - 30% of the patients, the low responders, sufficient weight loss is not achieved 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. Semaglutide is one of the medications that might improve outc...Show More
Detailed Description
The treatment of obesity can be divided into three different fields: non-surgical interventions (e.g. endoscopic techniques, swallowable gastric balloon), pharmacological, and surgical treatment. All these different fields have, as their cornerstone of treatment, lifestyle interventions. Lifestyle interventions have an emphasis on regulation of energy intake and improvement of physical activity. All treatment options...Show More
Official Title
Semaglutide 2.4mg for Low Responders After Bariatric Surgery
Conditions
ObesityObesity, MorbidWeight GainPublications
Scientific articles and research papers published about this clinical trial:Other Study IDs
- SEABAR
- NOK000024
NCT ID Number
Start Date (Actual)
2024-05
Last Update Posted
2024-03-01
Completion Date (Estimated)
2026-09
Enrollment (Estimated)
152
Study Type
Interventional
PHASE
Phase 4
Status
Not yet recruiting
Keywords
Obesity
Semaglutide
GLP-1
Bariatric Surgery
Weight Loss
Semaglutide
GLP-1
Bariatric Surgery
Weight Loss
Primary Purpose
Treatment
Design Allocation
Randomized
Interventional Model
Parallel
Masking
Double
Arms / Interventions
| Participant Group/Arm | Intervention/Treatment |
|---|---|
Active ComparatorSemaglutide 2.4mg Patients in this group will receive the active comparator semaglutide 2.4mg. This is a medication which is distributed by an intramuscular injection once weekly. | Semaglutide 2.4 MG/0.75 ML Subcutaneous Solution [WEGOVY] The semaglutide will be used in the allocated group in addition to our lifestyle program for the duration of 68 weeks in total. |
Placebo ComparatorPlacebo Patients in this group will receive the placebo. This is a placebo which is distributed by an intramuscular injection once weekly. | Placebo The placebo will be used in the allocated group in addition to our lifestyle program for the duration of 68 weeks in total. |
Primary Outcome Measures
Secondary Outcome Measures
| Outcome Measure | Measure Description | Time Frame |
|---|---|---|
Weight change from start study at 3 months post operative until 15 months later | To study the weight change from 3 until 18 months after surgery (% total weight loss, TWL) in low responders after bariatric surgery who are treated with Semaglutide 2.4 mg and a lifestyle intervention | 15 months |
Difference between placebo group and treatment group in weight change | compare change in weight to patients receiving placebo and a lifestyle intervention | 15 months |
| Outcome Measure | Measure Description | Time Frame |
|---|---|---|
Weight loss 3 months after surgery | To study the weight loss at 3 months after surgery (before semaglutide start) | 3 months |
Weight loss 6 months after surgery | To study the weight loss at 6 months after surgery (3 months after semaglutide start) | 6 months |
Weight loss 12 months after surgery | To study the weight loss at 12 months after surgery (9 months after semaglutide start) | 12 months |
Weight loss 18 months after surgery | To study the weight loss at18 months after surgery (15 months after semaglutide start) | 18 months |
Metabolic health before surgery (bloodpressure) | To study metabolic health before surgery (before semaglutide start) by using the following parameter: bloodpressure in mmHg | Screening for surgery |
Metabolic health before surgery (HbA1c) | To study metabolic health before surgery (before semaglutide start) by using the following parameter: HbA1c in mmol/mol | Screening for surgery |
Metabolic health before surgery (glucose) | To study metabolic health before surgery (before semaglutide start) by using the following parameter: glucose in mmol/l | Screening for surgery |
Metabolic health before surgery (triglyceride) | To study metabolic health before surgery (before semaglutide start) by using the following parameter: triglycerides in mmol/l | Screening for surgery |
Metabolic health before surgery (LDL) | To study metabolic health before surgery (before semaglutide start) by using the following parameter: LDL in mmol/l | Screening for surgery |
Metabolic health before surgery (HDL) | To study metabolic health before surgery (before semaglutide start) by using the following parameter: HDL in mmol/l | Screening for surgery |
Metabolic health before surgery (total cholesterol) | To study metabolic health before surgery (before semaglutide start) by using the following parameter: total cholesterol in mmol/l | Screening for surgery |
Metabolic health 3 months after surgery (Bloodpressure) | To study metabolic health 3 months after surgery (at semaglutide start) by using the following parameter: bloodpressure in mmHg | 3 months |
Metabolic health 3 months after surgery (HbA1c) | To study metabolic health 3 months after surgery (at semaglutide start) by using the following parameter: HbA1c mmol/mol | 3 months |
Metabolic health 3 months after surgery (glucose) | To study metabolic health 3 months after surgery (at semaglutide start) by using the following parameter: glucose in mmol/l | 3 months |
Metabolic health 3 months after surgery (triglyceride) | To study metabolic health 3 months after surgery (at semaglutide start) by using the following parameter: triglycerides in mmol/l | 3 months |
Metabolic health 3 months after surgery (LDL) | To study metabolic health 3 months after surgery (at semaglutide start) by using the following parameter: LDL in mmol/l | 3 months |
Metabolic health 3 months after surgery (HDL) | To study metabolic health 3 months after surgery (at semaglutide start) by using the following parameter: HDL in mmol/l | 3 months |
Metabolic health 3 months after surgery (total cholesterol) | To study metabolic health 3 months after surgery (at semaglutide start) by using the following parameter: total cholesterol in mmol/l | 3 months |
Metabolic health at 6 months after surgery (bloodpressure) | To study metabolic health 6 months after surgery (3 after semaglutide start) by using the following parameter: bloodpressure in mmHg | 6 months |
Metabolic health at 6 months after surgery (HbA1c) | To study metabolic health 6 months after surgery (3 after semaglutide start) by using the following parameter: HbA1c in mmol/mol | 6 months |
Metabolic health at 6 months after surgery (glucose) | To study metabolic health 6 months after surgery (3 after semaglutide start) by using the following parameter: glucose mmol/l | 6 months |
Metabolic health at 6 months after surgery (triglyceride) | To study metabolic health 6 months after surgery (3 after semaglutide start) by using the following parameter: triglycerides in mmol/l | 6 months |
Metabolic health at 6 months after surgery (LDL) | To study metabolic health 6 months after surgery (3 after semaglutide start) by using the following parameter: LDL in mmol/l | 6 months |
Metabolic health at 6 months after surgery (HDL) | To study metabolic health 6 months after surgery (3 after semaglutide start) by using the following parameter: HDL in mmol/l | 6 months |
Metabolic health at 6 months after surgery (total cholesterol) | To study metabolic health 6 months after surgery (3 after semaglutide start) by using the following parameter: total cholesterol in mmol/l | 6 months |
Metabolic health at 12 months after surgery (bloodpressure) | To study metabolic health 12 months after surgery (9 months after semaglutide start) by using the following parameter: bloodpressure in mmHg | 12 months |
Metabolic health at 12 months after surgery (HbA1c) | To study metabolic health 12 months after surgery (9 months after semaglutide start) by using the following parameter: HbA1c in mmol/mol | 12 months |
Metabolic health at 12 months after surgery (glucose) | To study metabolic health 12 months after surgery (9 months after semaglutide start) by using the following parameter: glucose in mmol/l | 12 months |
Metabolic health at 12 months after surgery (triglyceride) | To study metabolic health 12 months after surgery (9 months after semaglutide start) by using the following parameter: triglycerides in mmol/l | 12 months |
Metabolic health at 12 months after surgery (LDL) | To study metabolic health 12 months after surgery (9 months after semaglutide start) by using the following parameter: LDL in mmol/l | 12 months |
Metabolic health at 12 months after surgery (HDL) | To study metabolic health 12 months after surgery (9 months after semaglutide start) by using the following parameter: HDL in mmol/l | 12 months |
Metabolic health at 12 months after surgery (total cholesterol) | To study metabolic health 12 months after surgery (9 months after semaglutide start) by using the following parameter: total cholesterol in mmol/l | 12 months |
Metabolic health at 18 months after surgery (bloodpressure) | To study metabolic health 18 months after surgery (15 months after semaglutide start) by using the following parameter: bloodpressure in mmHg | 18 months |
Metabolic health at 18 months after surgery (HbA1c) | To study metabolic health 18 months after surgery (15 months after semaglutide start) by using the following parameter: HbA1c in mmol/mol | 18 months |
Metabolic health at 18 months after surgery (glucose) | To study metabolic health 18 months after surgery (15 months after semaglutide start) by using the following parameter: glucose mmol/l | 18 months |
Metabolic health at 18 months after surgery (triglyceride) | To study metabolic health 18 months after surgery (15 months after semaglutide start) by using the following parameter: triglycerides in mmol/l | 18 months |
Metabolic health at 18 months after surgery (LDL) | To study metabolic health 18 months after surgery (15 months after semaglutide start) by using the following parameter: LDL in mmol/l | 18 months |
Metabolic health at 18 months after surgery (HDL) | To study metabolic health 18 months after surgery (15 months after semaglutide start) by using the following parameter: HDL in mmol/l | 18 months |
Metabolic health at 18 months after surgery (total cholesterol) | To study metabolic health 18 months after surgery (15 months after semaglutide start) by using the following parameter: total cholesterol mmol/l | 18 months |
Health-related quality of life also related to gastro intestinal symptoms before surgery | To study health-related quality of life (HRQOL) also related to gastro-intestinal symptoms before surgery (before semaglutide start) using the BODY-Q questionnaire | Screening for surgery |
Health-related quality of life also related to gastro intestinal symptoms 3 months after surgery | To study health-related quality of life (HRQOL) also related to gastro-intestinal symptoms at start of treatment (at semaglutide start) questionnaire | 3 months |
Health-related quality of life also related to gastro intestinal symptoms 6 months after surgery | To study health-related quality of life (HRQOL) also related to gastro-intestinal symptoms 6 months after surgery (3 months after semaglutide start) questionnaire | 6 months |
Health-related quality of life also related to gastro intestinal symptoms | To study health-related quality of life (HRQOL) also related to gastro-intestinal symptoms 12 months after surgery (9 months after semaglutide start) questionnaire | 12 months |
Health-related quality of life also related to gastro intestinal symptoms | To study health-related quality of life (HRQOL) also related to gastro-intestinal symptoms 18 months after surgery (15 months after semaglutide start) questionnaire | 18 months |
Cardiorespiratory fitness level before surgery | To evaluate the change in cardiorespiratory fitness level of the participants before surgery (before semaglutide start ) using a VO2 max test | Screening for surgery |
Cardiorespiratory fitness level 3 months after surgery | To evaluate the change in cardiorespiratory fitness level of the participants 3 months after surgery (at semaglutide start) using a VO2 max test | 3 months |
Cardiorespiratory fitness level 6 months after surgery | To evaluate the change in cardiorespiratory fitness level of the participants 6 months after surgery (3 months after semaglutide start) using a VO2 max test | 6 months |
Cardiorespiratory fitness level 12 months after surgery | To evaluate the change in cardiorespiratory fitness level of the participants 12 months after surgery (9 months after semaglutide start) using a VO2 max test | 12 months |
Cardiorespiratory fitness level 18 months after surgery | To evaluate the change in cardiorespiratory fitness level of the participants 18 months after surgery (15 months after semaglutide start) using a VO2 max test | 18 months |
Change in liver fat and liver stiffness at start of treatment | To study the change in liver fat and liver stiffness, measured with vibration controlled transient elastography, at start of treatment with semaglutide | Screening for study |
Change in liver fat and liver stiffness 15 months after semaglutide start | To study the change in liver fat and liver stiffness, measured with vibration controlled transient elastography, 15 months after semaglutide start | 15 months |
To describe the persistence of therapy | The number of patients who persisted the therapy given in the study | 15 months |
To describe the average weekly dose | The number of patient on all possible dosages at the end of the study. | 15 months |
Participation Assistant
Eligibility Criteria
Eligible Ages
Adult, Older Adult
Minimum Age
18 Years
Eligible Sexes
All
- BMI before surgery was ≥ 35.0 kg/m2
- Patient is treated with group consultation at the NOK
- Patient has undergone a primary (banded) RYGB or (banded) sleeve gastrectomy (SG)
- Patient is in the lowest %TWL quartile, 3 months after surgery and will be enrolled in the plus module.
- Gastropareses or gastro-intestinal complaints after bariatric surgery
- Type 1 or type 2 diabetes and/or diabetic retinopathy
- 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)
- (expected) Pregnancy / breast-feeding
- Inflammatory Bowel Disease
- Thyroid malignancy in history
- Use of warfarin or other coumarin derivates
Zuyderland Medisch CentrumNederlandse Obesitas KliniekStudy Central Contact
Contact: Marijn Jense, MD, +3188-4599719, [email protected]
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