Preoperative Tirzepatide for Bariatric Surgery
试验速览
- 阶段
- 4 期
- 状态
- 招募中
- 发起方
- 入组人数
- 50
- 试验地点
- 2
- 主要终点
- Change in inflammatory markers c reactive protein (CRP)
研究概览
简要总结
This clinical trial will test whether preoperative tirzepatide treatment improves outcomes after bariatric surgery. The outcome of this study could impact therapeutic guidelines for the multimodal treatment of obesity.
The major objectives are:
- To evaluate whether pre-operative tirzepatide treatment reduces tissue and circulating inflammatory markers at the time of surgery.
- To establish the relationship of these changes with postoperative improvements in weight loss, metabolic and inflammatory profiles, comorbidity resolution (glycemic control, blood pressure, lipid profile), and 30-day surgical complications. Researchers will compare data from patients taking tirzepatide to data from patients not taking tirzepatide before their planned bariatric surgery to see if tirzepatide reduces inflammation and improves health outcomes after bariatric surgery.
Participants will:
Take or not take tirzepatide, depending on what study group they are in, once a week for 3 months.
Visit the endocrine clinic once a month for 3 months to be prescribed the drug and for checkups regarding side effects due to the drug.
Keep a diary to document taking the drug and any side effects. Continue with their planned bariatric surgery and post-surgery follow-ups according to their healthcare provider.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •adults who have been enrolled in the multidisciplinary metabolic and bariatric surgery program at the UK HealthCare Weight Loss Surgery Clinic and are scheduled to receive laparoscopic or robotic sleeve gastrectomy, or gastric bypass surgery
- •BMI greater than or equal to 40 kg/m2 with one or more obesity-related comorbidities
- •have demonstrated abstinence from any form of nicotine use, confirmed by serum nicotine and metabolite testing
- •enrollment in the ADORE Bariatric Tissue Bank (IRB #69767)
排除标准
- •any contraindication to the use of tirzepatide (per package insert)
- •Personal or family history of medullary thyroid carcinoma
- •Patients with Multiple Endocrine Neoplasm syndrome type 2
- •Hypersensitivity to tirzepatide
- •History of pancreatitis
- •Type 1 Diabetes
- •patients with active, untreated or symptomatic cholelithiasis or jaundice
- •consistent use of a GLP-1 or GLP-1/GIP receptor agonist, over the past 90 days
- •diagnosed autoimmune disease
- •current use of immunosuppressive agents or use within the past 30 days
- •moderate or severe substance use disorder according to DSM-5 criteria
- •uncontrolled significant psychiatric disorder as assessed by specialized bariatric psychologist
- •female participant who is pregnant, breast-feeding, or intends to become pregnant with in 1 year following surgery
- •a prisoner
研究组 & 干预措施
Standard of Care Alone
干预措施: Standard of Care (Behavioral)
Standard of Care plus Drug
Participant receives drug for 3 months prior to surgery
干预措施: tirzepatide (Drug)
结局指标
主要结局
Change in inflammatory markers c reactive protein (CRP)
时间窗: Baseline and 3 months post-drug
Inflammatory marker will be measured by ELISA in blood samples drawn from patient.
Change in inflammatory markers interleukin 6 (IL-6)
时间窗: Baseline and 3 months post-drug
Inflammatory marker will be measured by ELISA in blood samples drawn from patient.
Change in inflammatory markers tumor necrosis factor (TNF)
时间窗: Baseline and 3 months post-drug
Inflammatory marker will be measured by ELISA in blood samples drawn from patient.
change in inflammatory markers (leptin)
时间窗: Baseline and 3 months post-drug
Inflammatory marker will be measured by ELISA in blood samples drawn from patient.
change in inflammatory markers (adiponectin)
时间窗: Baseline and 3 months post-drug
Inflammatory marker will be measured by ELISA in blood samples drawn from patient.
change in inflammatory markers renin-angiotensin-aldosterone system (RAAS)
时间窗: Baseline and 3 months post-drug
Inflammatory markers will be measured by ELISA in blood samples drawn from patient.
RNA sequencing
时间窗: at time of surgery
Bulk RNA sequencing analyses will be performed on tissue samples of fat and liver collected at the time of surgery
次要结局
- Change in weight(Baseline, 3 months post-drug, 1-, 3-, 6-, and 12-months post surgery)
- 30-day surgical complications(1-, 3-, 6-, and 12-months post surgery)
- change in inflammatory markers c reactive protein (CRP)(1-, 3-, 6-, and 12-months post surgery)
- change in inflammatory markers interleukin 6 (IL-6)(1-, 3-, 6-, and 12-months post surgery)
- change in inflammatory markers tumor necrosis factor (TNF)(1-, 3-, 6-, and 12-months post surgery)
- change in inflammatory markers (leptin)(1-, 3-, 6-, and 12-months post surgery)
- change in inflammatory markers (adiponectin)(1-, 3-, 6-, and 12-months post surgery)
- change in inflammatory markers renin-angiotensin-aldosterone system (RAAS)(1-, 3-, 6-, and 12-months post surgery)
- change in blood pressure(Baseline, 3 months post-drug, 1-, 3-, 6-, and 12-months post surgery)
- Change in Hemoglobin A1c(Baseline, 3 months post-drug, 1-, 3-, 6-, and 12-months post surgery)
- change in blood glucose(Baseline, 3 months post-drug, 1-, 3-, 6-, and 12-months post surgery)
- change in cholesterol(Baseline, 3 months post-drug, 1-, 3-, 6-, and 12-months post surgery)
- change in high-density lipoprotein (HDL)(Baseline, 3 months post-drug, 1-, 3-, 6-, and 12-months post surgery)
- change in low-density lipoprotein (LDL)(Baseline, 3 months post-drug, 1-, 3-, 6-, and 12-months post surgery)
- change in triglycerides(Baseline, 3 months post-drug, 1-, 3-, 6-, and 12-months post surgery)
- change in insulin(Baseline, 3 months, post-drug, 1-, 6-, and 12-months post surgery)
研究者
Marlene Starr
Associate Professor
University of Kentucky