[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-studies-list:{\"overallStatus\":[\"RECRUITING\",\"AVAILABLE\",\"NOT_YET_RECRUITING\"],\"leadSponsorName\":\"Carsten Dirksen\",\"orderBy\":\"LastUpdateSubmitDate:desc\",\"size\":25,\"offset\":0}":3,"health-study-condition:":62},{"pageToken":4,"total":5,"offset":6,"count":5,"results":7},null,2,0,[8,42],{"id":9,"slug":10,"hasResults":11,"nctId":12,"briefTitle":13,"officialTitle":14,"acronym":15,"eligibilityCriteria":16,"healthyVolunteers":11,"sex":17,"minAge":18,"maxAge":19,"enrollmentInfo":20,"targetDuration":4,"studyType":23,"phases":24,"briefSummary":26,"conditions":27,"keywords":4,"overallStatus":29,"whyStopped":4,"lastUpdateSubmitDate":30,"lastUpdatePostDateStruct":31,"startDateStruct":34,"completionDateStruct":36,"leadSponsor":38,"locationsCount":41},"100539853","intensive-weight-loss-intervention-versus-bariatric-surgery-for-adults-with-severe-and-complex-obesity-the-lightbar-randomised-trial-100539853",false,"NCT06309238","Intensive Weight Loss Intervention Versus Bariatric Surgery for Adults With Severe and Complex Obesity: the LightBAR Randomised Trial","Intensive Weight Loss Intervention Versus Bariatric Surgery for Adults With Severe and Complex Obesity: the LightBAR Randomised Trial. Lighthouse Consortium on Obesity Management (LightCOM) Trial no 4","LightBAR","Please note that participants need to be invited in order to take part in the trial.\n\nInclusion Criteria:\n\n* Aged 18 to 60 years (inclusive) at time of screening.\n* Eligible for and willing to undergo bariatric surgery, i.e., fulfilment of criteria for bariatric surgery from the respective national health authorities:\n\n  * DK: BMI ≥ 35 kg\u002Fm2 with one or more of the following: T2D, severe hypertension, sleep apnoea requiring treatment, symptomatic arthrosis in lower extremities, female infertility related to overweight, or BMI\\>40 kg\u002Fm2 with other strong medical reasons for weight loss (28). Prior to surgery, an 8% weight loss is required as well as smoking cessation.\n  * UK: BMI of 35 kg\u002Fm2 to 40 kg\u002Fm2 and other significant disease (e.g., type 2 diabetes or high blood pressure), or BMI ≥40 kg\u002Fm2. Has been or is willing to receive intensive management in a specialist tier 3 obesity service (29).\n* Fit for anaesthesia and surgery.\n* Informed consent.\n\nExclusion Criteria:\n\n* Prior bariatric or hiatal surgery, not including intragastric balloons or duodenal-jejunal bypass sleeve (Endobarrier™ or similar) if the device has been removed \\>1 year before screening.\n* Use of any WLM (including liraglutide and semaglutide for diabetes) within last 3 months.\n* Conditions that contraindicate or complicate total diet replacement (including type 1 diabetes or other diabetes requiring basal bolus insulin therapy or insulin pump therapy (for Denmark) and any diabetes requiring insulin therapy (for UK), phenylketonuria, or other conditions requiring strict adherence to special diets).\n* Conditions that contraindicate or complicate treatment with GLP-1 receptor analogues (including history of pancreatitis or known allergies).\n* Conditions that contraindicate or complicate bariatric surgery (GI motility disorders, large abdominal wall hernia, large hiatus hernia (\\>5cm), Crohn's disease, liver cirrhosis, or other conditions preventing laparoscopic bariatric surgery e.g. multiple previous abdominal surgery).\n* Conditions that contraindicate or complicate study adherence and bariatric surgery (mental disorder, unstable psychiatric disease, recent history of alcohol\u002Fmedication abuse, cancer treatment within 5 years).\n* Pregnant or planning pregnancy in the next two years or currently breast feeding.\n* Not achieving a 5% weight loss within 12 weeks prior to randomisation.\n* People taking part in other research involving multidisciplinary obesity treatment that would compromise their participation in this trial.\n* Another member of the household enrolled in the trial.\n* Diagnosis of or treatment for severe eating disorder within the last 6 months.","ALL","18 Years","60 Years",{"count":21,"type":22},500,"ESTIMATED","INTERVENTIONAL",[25],"NA","With this trial, the aim is to assess the benefits and harms of a non-surgical intensive weight loss intervention that includes total dietary replacements, behavioural support and weight-loss medication compared with bariatric surgery for people with severe and complex obesity. The interpretation of the results will help inform future care pathways for people with obesity in whom bariatric surgery is currently the only available effective treatment option.",[28],"Obesity","RECRUITING","2026-08-20",{"date":32,"type":33},"2026-08-21","ACTUAL",{"date":35,"type":33},"2024-05-08",{"date":37,"type":22},"2048-12",{"name":39,"class":40},"Carsten Dirksen","OTHER",14,{"id":43,"slug":44,"hasResults":11,"nctId":45,"briefTitle":46,"officialTitle":47,"acronym":48,"eligibilityCriteria":49,"healthyVolunteers":11,"sex":17,"minAge":18,"maxAge":19,"enrollmentInfo":50,"targetDuration":4,"studyType":23,"phases":52,"briefSummary":53,"conditions":54,"keywords":4,"overallStatus":29,"whyStopped":4,"lastUpdateSubmitDate":55,"lastUpdatePostDateStruct":56,"startDateStruct":58,"completionDateStruct":60,"leadSponsor":61,"locationsCount":41},"100540793","intensive-weight-loss-intervention-versus-usual-care-for-adults-with-severe-and-complex-obesity-100540793","NCT06321458","Intensive Weight Loss Intervention Versus Usual Care for Adults With Severe and Complex Obesity","Intensive Weight Loss Intervention Versus Usual Care for Adults With Severe and Complex Obesity: the LightWAY Randomised Trial: Lighthouse Consortium on Obesity Management (LightCOM) Trial no 3","LightWAY","Please note that participants need to be invited in order to take part in the trial\n\nInclusion Criteria:\n\n1. Age ≥18 years and ≤60 years old at screening.\n2. Has severe and complex obesity i.e. BMI\\>35 or \\>32.5 in people with South Asian, Chinese, other Asian, Middle Eastern, Black African or African-Caribbean family backgrounds and with one or more of these specific adiposity-related chronic diseases of cardiovascular disease, type 2 diabetes, hypertension, non-alcoholic steatosis, or sleep apnoea.\n3. Provides informed consent.\n\nExclusion Criteria:\n\n1. Intending to become pregnant in the next two years or pregnant or breastfeeding.\n2. Use of WLM or GLP-1 agonist treatment within the last three months.\n3. Currently being treated for cancer other than oestrogen antagonist therapy or non-melanoma skin cancer.\n4. Prior bariatric surgery, not including laparoscopic gastric banding, intragastric balloons or duodenal-jejunal bypass sleeve (Endobarrier™ or similar) if the device has been removed \\>1 year before screening.\n5. Diagnosis of or treatment for severe eating disorder within the last 6 months.\n6. Any other disease that markedly compromises the participant's ability to adhere to the treatment programme or follow-up or is likely to mean that weight loss will not improve the person's length or quality of life, such as conditions limiting life expectancy.\n7. Conditions that contraindicate or complicate TDR (including type 1 diabetes or other diabetes requiring insulin therapy, phenylketonuria, or other conditions requiring special diets).\n8. Conditions that contraindicate or complicate GLP-1 treatment (including history of pancreatitis)\n9. Taking part in other research involving multidisciplinary obesity treatment would compromise participation in this trial.\n10. Another member of the household enrolled in the trial.",{"count":51,"type":22},600,[25],"In this trial, the aim is to assess the clinical benefits and harms, as well as cost-effectiveness of an intensive weight loss (IWL) intervention that includes total dietary replacements, behavioural support and weight-loss medication compared with existing weight management programmes within primary care for people with severe and complex obesity.",[28],"2025-11-27",{"date":57,"type":33},"2025-12-01",{"date":59,"type":33},"2024-04-29",{"date":37,"type":22},{"name":39,"class":40},""]