2024 Tirzepatide-Bariatric Surgery

Официальное название

Preoperative Tirzepatide for Bariatric Surgery

Обзор

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: 1. To evaluate whether pre-operative tirzepatide treatment reduces tissue and circulating inflammatory markers at the time of surgery. 2. 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.

Вмешательства

• Препарат tirzepatide
  Participants will be educated on dietary and lifestyle changes. Participants will self inject 2.5 mg tirzepatide subcutaneously once weekly and maintain a drug administration diary. Dose escalation will proceed per package directions if instructed by study team at follow up visits.
• Поведенческое Standard of Care
  Participants will be educated on dietary and lifestyle changes

Первичные конечные точки

• Change in inflammatory markers c reactive protein (CRP) [Срок оценки: Baseline and 3 months post-drug]
• Change in inflammatory markers interleukin 6 (IL-6) [Срок оценки: Baseline and 3 months post-drug]
• Change in inflammatory markers tumor necrosis factor (TNF) [Срок оценки: Baseline and 3 months post-drug]
• change in inflammatory markers (leptin) [Срок оценки: Baseline and 3 months post-drug]
• change in inflammatory markers (adiponectin) [Срок оценки: Baseline and 3 months post-drug]
• change in inflammatory markers renin-angiotensin-aldosterone system (RAAS) [Срок оценки: Baseline and 3 months post-drug]
• RNA sequencing [Срок оценки: at time of surgery]

Вторичные конечные точки (12)

• Change in weight [Срок оценки: Baseline, 3 months post-drug, 1-, 6-, and 12-months post surgery]
• 30-day surgical complications [Срок оценки: 1-,6-, and 12-months post surgery]
• change in inflammatory markers c reactive protein (CRP) [Срок оценки: 1-, 6-, and 12-months post surgery]
• change in inflammatory markers interleukin 6 (IL-6) [Срок оценки: 1-, 6-, and 12-months post surgery]
• change in inflammatory markers tumor necrosis factor (TNF) [Срок оценки: 1-, 6-, and 12-months post surgery]
• change in inflammatory markers (leptin) [Срок оценки: 1-, 6-, and 12-months post surgery]
• change in inflammatory markers (adiponectin) [Срок оценки: 1-, 6-, and 12-months post surgery]
• change in inflammatory markers renin-angiotensin-aldosterone system (RAAS) [Срок оценки: 1-, 6-, and 12-months post surgery]
• change in blood pressure [Срок оценки: Baseline, 3 months post-drug, 1-, 6-, and 12-months post surgery]
• Change in Hemoglobin A1c [Срок оценки: Baseline, 3 months post-drug, 1-, 6-, and 12-months post surgery]
• change in blood glucose [Срок оценки: Baseline, 3 months post-drug, 1-, 6-, and 12-months post surgery]
• change in cholesterol [Срок оценки: Baseline, 3 months post-drug, 1-, 6-, and 12-months post surgery]

Критерии участия

Критерии включения

• 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)

Критерии исключения

• 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

Критерии приведены из реестра в оригинале (на английском). Окончательную оценку соответствия проводит исследовательский центр.

Здоровые добровольцы: Нет

Дизайн исследования

Распределение

Рандомизированное

Модель

Параллельные группы

Маскирование

Открытое

Основная цель

Лечение

Центры проведения

США · 1 центр

• University of Kentucky — Lexington

Публикации

• Jain V, McMullen CA, Kimbrough JI, Rockich AK, Davenport DL, Hawk GS, Nikolajczyk BS, Kern PA, Fisher SJ, Steiner JP, Inabnet WB 3rd, Starr ME. Preoperative Glucagon-like Peptide-1 Therapy in Bariatric Surgery Patients With Morbid Obesity (PreMO): Rationale and Study Design for a Randomized Controlled Trial. J Surg Res. 2026 Mar;319:58-65. doi: 10.1016/j.jss.2026.01.004. Epub 2026 Feb 4. PMID 41643256

Идентификаторы

NCT: NCT06721507 · 97933

Первоисточники (государственные реестры)

• ClinicalTrials.gov (NIH, США)

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