Clinical and Neurobehavioral Changes With Weight Loss Drug Discontinuation and Reinitiation

Официальное название

Clinical and Neurobehavioral Changes With GLP-1 (Glucagon-like Peptide-1) Discontinuation

Обзор

The goal of this clinical study with research procedures is to learn how stopping and restarting tirzepatide (a medication that helps regulate blood sugar and appetite) affects brain activity, behavior, and health in adults ages 18-70 who are currently taking tirzepatide. Specifically, the study aims to examine how a short pause in tirzepatide affects hunger, mood, sleep, and daily functioning; how stopping and restarting tirzepatide alters brain chemistry and brain responses to food-related images; and how these changes relate to health measures such as quality of life and emotional well-being. There is no comparison group; instead, researchers will assess changes within each participant across three time points: while taking tirzepatide, after stopping it for 3-4 weeks, and after restarting it for 6-8 weeks. Participants will attend three in-person visits lasting approximately 3-4 hours each, during which they will complete interviews, questionnaires, and cognitive tasks; provide a urine sample (pregnancy screening for females); undergo a brain scan using magnetic resonance imaging (MRI) and MR spectroscopy (MRS); and receive a kit to provide a small stool sample. Participants will also complete two brief check-in phone calls between visits and the online BrainHealth Index between sessions, which includes surveys and cognitive tasks. All changes to tirzepatide use will occur under the supervision of a study physician to support participant safety and comfort, and the total study duration is approximately 13 weeks.

Подробное описание

This study specifically recruits individuals currently being prescribed for tirzepatide. The experimental design will consist of a brief discontinuation of the drug for roughly 3-4 weeks followed by a reinitiation of the medication. Prescription and administration of tirzepatide is done as part of normal patient care and is not a component of the study.

Вмешательства

• Другое Discontinuation and Reinitiation of Tirzepatide
  Participants will temporarily pause their tirzepatide medication for 3-4 weeks and then restart it for 6-8 weeks under the supervision of a study physician. The medication change is done only for research purposes to study how stopping and restarting tirzepatide affects brain activity, appetite, mood, and other health measures. During this period, participants will complete MRI scans, behavioral assessments, questionnaires, and provide stool samples across three study visits.

Первичные конечные точки

• Change From On-Treatment to Discontinuation and Re-Initiation in Food Cue-Evoked BOLD Response in Reward and Salience Brain Regions [Срок оценки: Baseline (on tirzepatide), 3-4 weeks of discontinuation, and 6-8 weeks of re-initiation]

Вторичные конечные точки (12)

• Change From Baseline in Resting-State Functional Connectivity Within Salience and Executive Control Networks [Срок оценки: Baseline (on tirzepatide), 3-4 weeks of discontinuation, and 6-8 weeks of re-initiation]
• Change From Baseline in Brain Glutamate Levels [Срок оценки: Baseline (on tirzepatide), 3-4 weeks of discontinuation, and 6-8 weeks of re-initiation]
• Change From Baseline in State Food Craving Severity [Срок оценки: Baseline (on tirzepatide), 3-4 weeks of discontinuation, and 6-8 weeks of re-initiation]
• Change From Baseline in Blood-Brain Permeability Levels [Срок оценки: Baseline (on tirzepatide), 3-4 weeks of discontinuation, and 6-8 weeks of re-initiation]
• Change From Baseline in Trait Food Craving Severity. [Срок оценки: Baseline (on tirzepatide), 3-4 weeks of discontinuation, and 6-8 weeks of re-initiation]
• Change From Baseline in Addictive-Like Eating Symptoms. [Срок оценки: Baseline (on tirzepatide), 3-4 weeks of discontinuation, and 6-8 weeks of re-initiation]
• Change From Baseline in Intrusive Food-Related Thoughts. [Срок оценки: Baseline (on tirzepatide), 3-4 weeks of discontinuation, and 6-8 weeks of re-initiation]
• Change From Baseline in Dietary Pattern Quality. [Срок оценки: Baseline (on tirzepatide), 3-4 weeks of discontinuation, and 6-8 weeks of re-initiation]
• Change From Baseline in Perceived Loss of Control Over Eating. [Срок оценки: Baseline (on tirzepatide), 3-4 weeks of discontinuation, and 6-8 weeks of re-initiation]
• Change From Baseline in Psychological Responsiveness to Food Availability. [Срок оценки: Baseline (on tirzepatide), 3-4 weeks of discontinuation, and 6-8 weeks of re-initiation]
• Change From Baseline in Uncontrolled Eating Behavior. [Срок оценки: Baseline (on tirzepatide), 3-4 weeks of discontinuation, and 6-8 weeks of re-initiation]
• Change From Baseline in Mood Disturbance. [Срок оценки: Baseline (on tirzepatide), 3-4 weeks of discontinuation, and 6-8 weeks of re-initiation]

Критерии участия

Критерии включения

• Aged 18-70 years.
• Currently on tirzepatide.
• Currently receiving care from University of Texas- Southwestern (UTSW) Weight Wellness Clinic.
• Cognitively capable of understanding and signing informed consent.
• Be proficient in English.

Критерии исключения

• History of major neurological or psychiatric disorders, including substance use disorders that might confound brain imaging results (e.g., stroke, epilepsy, multiple sclerosis, schizophrenia, major depression requiring hospitalization).
• Diagnosis of Type 2 Diabetes.
• Current diagnosis of an eating disorder.
• Use of medications affecting weight other than tirzepatide.
• Pregnancy or breastfeeding.
• MR contraindications:
• Heart pacemaker, heart valve replacement, or aortic clips
• Metal fragments in the eyes, skin, or elsewhere in the body
• Brain clips or pieces of metal used in aneurysm surgery or intercranial bypass
• Venous umbrella
• Pieces of metal in the body resulting from work as a sheet-metal worker or welder
• Clips placed in an internal organ
• Prosthetic devices, such as middle ear, eye, joint, or penile implants
• Joint replacement
• Hearing aid that cannot be removed
• Neurostimulator
• Insulin pump
• Shunts or stents
• Metal mesh or coil implants
• Metal plate, pin, screws, or wires, or any other metal implants

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

Здоровые добровольцы: Нет

Дизайн исследования

Распределение

Не применимо

Модель

Одна группа

Маскирование

Открытое

Основная цель

Фундаментальное исследование

Центры проведения

США · 1 центр

• Center for BrainHealth — Dallas

Публикации

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• Baker F, Denniston M, Zabora J, Polland A, Dudley WN. A POMS short form for cancer patients: psychometric and structural evaluation. Psychooncology. 2002 Jul-Aug;11(4):273-81. doi: 10.1002/pon.564. PMID 12203741

Идентификаторы

NCT: NCT07387796 · IRB-26-3

Первоисточники (государственные реестры)

• ClinicalTrials.gov (NIH, США)

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