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临床试验 NCT06132477 针对病态肥胖，代谢综合征，糖尿病，高血压，成人阻塞性睡眠呼吸暂停目前招募中。请查看临床试验雷达卡片视图和 AI 发现工具了解所有详情，或在此提出任何问题。 | ||
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密苏里大学哥伦比亚分校Impact GLP-1 Agonists Following Bariatric IV期 150 微生物组 随机化
临床试验详情主要以英语提供。然而，试验雷达 AI可以提供帮助！只需点击“试验详解”即可查看和讨论您选择的语言的试验信息。
临床试验NCT06132477旨在研究治疗，主要针对病态肥胖，代谢综合征，糖尿病，高血压，成人阻塞性睡眠呼吸暂停。这是一项IV期 干预性研究试验，目前试验状态为招募中。试验始于2024年2月1日，计划招募150名患者。该研究由密苏里大学哥伦比亚分校主导，预计于2030年7月1日完成。试验数据来源于ClinicalTrials.gov，最后更新时间为2026年1月22日。
简要概括
Glucagon-like peptide 1 (GLP-1) is a hormone that helps regulate blood glucose levels through improved insulin sensitivity and release of insulin from the pancreas, control hunger, induce satiety and plays a role in the metabolic health of a person. GLP-1 receptor agonists (GLP1-RAs) have been shown to be effective in achieving weight loss in patients with type 2 diabetes while improving blood glucose control. Bariat...显示更多
详细描述
Preliminary Work To date we have established a randomized controlled clinical trial where we are comparing groups of patients with variable lengths of biliopancreatic limb lengths during gastric bypass. VSG patients serve as a control surgical group, and we have gathered both serum and stool in over 200 patients. We have collaborated with both the institutional metagenomics and proteomics centers to process samples a...显示更多
官方标题
Biometabolic Impact of Continuation of GLP-1 Agonists Following Bariatric
疾病
病态肥胖代谢综合征糖尿病高血压成人阻塞性睡眠呼吸暂停出版物
关于此临床试验发表的科学文章和研究论文：其他研究标识符
- 2098885
NCT编号
实际开始日期
2024-02-01
最近更新发布
2026-01-22
预计完成日期
2030-07
计划入组人数
150
研究类型
干预性研究
试验分期 (阶段)
IV期
试验状态
招募中
关键词
glp-1 agonist
Morbid Obesity
Bariatric Surgery
Metabolic syndrome
Diabetes Mellitus
Hypertension
Obstructive Sleep Apnea
Morbid Obesity
Bariatric Surgery
Metabolic syndrome
Diabetes Mellitus
Hypertension
Obstructive Sleep Apnea
主要目的
治疗方法
分配方式
随机
干预模型
交叉设计
盲法
无（开放性试验）
试验组/干预措施
| 参与者组/试验组 | 干预措施/治疗方法 |
|---|---|
阳性对照GLP-1 Agonist Group This cohort will consist of patients undergoing bariatric surgery who are currently receiving a GLP-1 Agonists for weight loss and/or diabetes management, that will be maintained on their preoperative dose of GLP-1 agonist following their bariatric surgery. This includes semaglutide, tirzepitide, among others. The dosage will be variable, but will be the same dose the patient is on prior to the bariatric surgery. Dur...显示更多 | GLP-1 receptor agonist Randomized to continue or discontinue GLP-1 receptor agonists after bariatric surgery |
无干预Non-GLP-1 Agonist Group This cohort will consist of patients undergoing bariatric surgery who are currently receiving a GLP-1 Agonist for weight loss and/or diabetes management that will be required to stop taking their preoperative dose of GLP-1 agonist following their bariatric surgery. Dosage preoperative will be variable based on what the patient is currently taking, as well as the medication being taken. | 不适用 |
主要终点
| 结果指标 | 度量标准描述 | 时间框架 |
|---|---|---|
Effect of GLP1-RA on weight loss | To investigate the effects of GLP1-RAs on weight loss reflected as change in BMI (kg per meter sq) in patients undergoing metabolic surgery | 6 months |
Effect of GLP1-RA on circulating bile acids and metabolites | Determine the impact of GLP1-RA on circulating bile acids and other metabolites | 6 months |
Effector of GLP1-RA on gut microbiome diversity | To determine the impact of GLP1-RAs after bariatric surgery on changes in the gut microbiome | 6 months |
Effect of GLP1-RA on satiety and hunger | To assess the impact of GLP-1 agonists on satiety and hunger in patients who undergo metabolic surgery. Scale will be a validated scoring system, "Daily Eats Questionnaire," with scores ranging from 0-10, with a 0 indicating no hunger, and 10 indicating extreme hunger | 6 months |
Effect of GLP1-RA on Glycemic control | HGBA1C levels will be measured at 3 and 6 months after surgery to determine if HGBA1C drops more in patients maintained on GLP1-RA | 6 months |
参与助手
资格标准
适龄参与研究
成人, 老年人
最低年龄要求
18 Years
适龄性别
全部
- Greater than 18 years of age
- Participation in care by one of the surgeons at MU Health Care
- Undergoing surgical weight loss through the Weight Management and Metabolic Center
- Body mass index of 30-80 kg/m2
- Meet insurance criteria, as set forth by the patient's insurance policy, to qualify for coverage for weight loss surgery or as a self-pay patient for the weight loss procedure
- Planned laparoscopic Roux-en-Y gastric bypass, sleeve gastrectomy, revisional weight loss surgery, or duodenal switch or modification of. If patients are not willing to be randomized they will not be enrolled as randomized but can still participate having samples collected.
- Willingness to have blood collected before and after surgical procedure at defined points or at minimum have clinical data collected.
- Willingness to have clinical data entered into a prospective database
- Additional specimens collected as stated in the protocol will be offered but collection not mandated.
5. Taking a GLP-1 agonist as part of their routine medical care apart from any planned surgical procedure. The current standard of care regarding continuation or discontinuation of GLP-1 agonists has not been established and is at the discretion of members of the patient's medical team but to be included the patient and medical care team must be willing to continue or discontinue the GLP-1 agonist after surgery depending on the randomized group.
- Pregnant patient
- Desire to not participate
- Age less than 18
- Patient fails to fulfill insurance mandated criteria and is not interested in paying cash for their procedure
- Not taking a GLP-1 agonist as part of standard medical care
- Unwilling to follow-up at required postoperative visits
- Unwilling to stop GLP-1 agonist if randomized into group to stop GLP-1 agonist or unwilling to continue the GLP-1 agonist if randomized into that respective group. If chooses to continue or discontinue the medication apart from randomization the patient can still participate as a non-randomized participant
密苏里大学哥伦比亚分校94 个活跃的临床试验可供探索American Society for Metabolic and Bariatric Surgery研究责任方
Andrew Wheeler, 主要研究者, Assistant Professor of Surgery, University of Missouri-Columbia
研究中心联系人
联系人: Jennifer Randolph, 573-882-4387, [email protected]
1 位于 1 个国家/地区的研究中心
Missouri
University of Missouri Hospital, Columbia, Missouri, 65201, United States
Andrew Wheeler, MD, 联系人, 573-882-5609, [email protected]
Milot Thaqi, MD, 联系人, 7086421788, [email protected]
招募中