Obesity Clinical Trial
— SEABAROfficial title:
Semaglutide 2.4mg for Low Responders After Bariatric Surgery
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 outcome in the post-bariatric population. Semaglutide is a Glucagon-like peptide-1 (GLP-1) receptor analogue developed to treat type 2 diabetes. It causes glucose-dependent insulin secretion, promotes satiety and inhibits glucagon secretion. In obese (non-bariatric) patients, semaglutide has shown to improve glycemic control, decrease blood pressure, lower cardiovascular risk, and decrease body weight.
Status | Not yet recruiting |
Enrollment | 152 |
Est. completion date | September 2026 |
Est. primary completion date | February 2026 |
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 (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. Exclusion Criteria: - 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 |
Country | Name | City | State |
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n/a |
Lead Sponsor | Collaborator |
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Zuyderland Medisch Centrum | Nederlandse Obestias Kliniek (NOK) |
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* Note: There are 23 references in all — Click here to view all references
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | 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 | |
Primary | Difference between placebo group and treatment group in weight change | compare change in weight to patients receiving placebo and a lifestyle intervention | 15 months | |
Secondary | Weight loss 3 months after surgery | To study the weight loss at 3 months after surgery (before semaglutide start) | 3 months | |
Secondary | Weight loss 6 months after surgery | To study the weight loss at 6 months after surgery (3 months after semaglutide start) | 6 months | |
Secondary | Weight loss 12 months after surgery | To study the weight loss at 12 months after surgery (9 months after semaglutide start) | 12 months | |
Secondary | Weight loss 18 months after surgery | To study the weight loss at18 months after surgery (15 months after semaglutide start) | 18 months | |
Secondary | 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 | |
Secondary | 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 | |
Secondary | 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 | |
Secondary | 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 | |
Secondary | 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 | |
Secondary | 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 | |
Secondary | 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 | |
Secondary | 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 | |
Secondary | 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 | |
Secondary | 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 | |
Secondary | 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 | |
Secondary | 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 | |
Secondary | 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 | |
Secondary | 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 | |
Secondary | 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 | |
Secondary | 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 | |
Secondary | 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 | |
Secondary | 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 | |
Secondary | 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 | |
Secondary | 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 | |
Secondary | 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 | |
Secondary | 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 | |
Secondary | 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 | |
Secondary | 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 | |
Secondary | 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 | |
Secondary | 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 | |
Secondary | 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 | |
Secondary | 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 | |
Secondary | 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 | |
Secondary | 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 | |
Secondary | 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 | |
Secondary | 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 | |
Secondary | 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 | |
Secondary | 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 | |
Secondary | 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 | |
Secondary | 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 | |
Secondary | 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 | |
Secondary | 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 | |
Secondary | 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 | |
Secondary | 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 | |
Secondary | 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 | |
Secondary | 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 | |
Secondary | 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 | |
Secondary | 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 | |
Secondary | 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 | |
Secondary | 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 | |
Secondary | 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 | |
Secondary | To describe the persistence of therapy | The number of patients who persisted the therapy given in the study | 15 months | |
Secondary | To describe the average weekly dose | The number of patient on all possible dosages at the end of the study. | 15 months |
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