Clinical and Neurobehavioral Changes With GLP-1 (Glucagon-like Peptide-1) Discontinuation
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 40
- 试验地点
- 1
- 主要终点
- Change From On-Treatment to Discontinuation and Re-Initiation in Food Cue-Evoked BOLD Response in Reward and Salience Brain Regions
研究概览
简要总结
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.
详细描述
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.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Basic Science
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 70 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •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.
排除标准
- •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
研究组 & 干预措施
Tirzepatide Discontinuation and Re-Initiation Arm
Participants in this single-group arm will complete three study visits that occur while they are taking tirzepatide, during a 3-4 week pause from the medication, and after they restart tirzepatide for 6-8 weeks. All medication changes are supervised by a study physician. At each visit, participants will complete interviews, questionnaires, cognitive tasks, magnetic resonance imaging (MRI) brain scans, and provide stool samples. They will also complete two short check-in phone calls and an online BrainHealth Index assessment between visits.
干预措施: Discontinuation and Reinitiation of Tirzepatide (Other)
结局指标
主要结局
Change From On-Treatment to Discontinuation and Re-Initiation in Food Cue-Evoked BOLD Response in Reward and Salience Brain Regions
时间窗: Baseline (on tirzepatide), 3-4 weeks of discontinuation, and 6-8 weeks of re-initiation
This outcome measures within-participant change in blood-oxygen-level-dependent (BOLD) signal during a food cue reactivity task, assessed using functional magnetic resonance imaging (fMRI). BOLD response will be quantified as the mean percent signal change in predefined reward- and salience-related regions of interest (including the ventral striatum and insula) during food image presentation relative to non-food control images. Higher BOLD values indicate greater neural responsivity to food cues.
次要结局
- Change From Baseline in Perceived Loss of Control Over Eating.(Baseline (on tirzepatide), 3-4 weeks of discontinuation, and 6-8 weeks of re-initiation)
- Change From Baseline in Mood Disturbance.(Baseline (on tirzepatide), 3-4 weeks of discontinuation, and 6-8 weeks of re-initiation)
- Change From Baseline in Resting-State Functional Connectivity Within Salience and Executive Control Networks(Baseline (on tirzepatide), 3-4 weeks of discontinuation, and 6-8 weeks of re-initiation)
- Change From Baseline in Brain Neuromelanin Signal(Baseline (on tirzepatide), 3-4 weeks of discontinuation, and 6-8 weeks of re-initiation)
- Change From Baseline in Brain Glutamate Levels(Baseline (on tirzepatide), 3-4 weeks of discontinuation, and 6-8 weeks of re-initiation)
- Change From Baseline in Trait Food Craving Severity.(Baseline (on tirzepatide), 3-4 weeks of discontinuation, and 6-8 weeks of re-initiation)
- Change From Baseline in State Food Craving Severity(Baseline (on tirzepatide), 3-4 weeks of discontinuation, and 6-8 weeks of re-initiation)
- Change From Baseline in Addictive-Like Eating Symptoms.(Baseline (on tirzepatide), 3-4 weeks of discontinuation, and 6-8 weeks of re-initiation)
- Change From Baseline in Intrusive Food-Related Thoughts.(Baseline (on tirzepatide), 3-4 weeks of discontinuation, and 6-8 weeks of re-initiation)
- Change From Baseline in Dietary Pattern Quality.(Baseline (on tirzepatide), 3-4 weeks of discontinuation, and 6-8 weeks of re-initiation)
- Change From Baseline in Attentional Bias Toward Food Cues.(Baseline (on tirzepatide), 3-4 weeks of discontinuation, and 6-8 weeks of re-initiation)
- Change From Baseline in Psychological Responsiveness to Food Availability.(Baseline (on tirzepatide), 3-4 weeks of discontinuation, and 6-8 weeks of re-initiation)
- Change From Baseline in Uncontrolled Eating Behavior.(Baseline (on tirzepatide), 3-4 weeks of discontinuation, and 6-8 weeks of re-initiation)
- Change From Baseline in Perceived Stress.(Baseline (on tirzepatide), 3-4 weeks of discontinuation, and 6-8 weeks of re-initiation)
- Change From Baseline in Emotional Health and Psychological Well-Being.(Baseline (on tirzepatide), 3-4 weeks of discontinuation, and 6-8 weeks of re-initiation)
- Change From Baseline in Quality of Life.(Baseline (on tirzepatide), 3-4 weeks of discontinuation, and 6-8 weeks of re-initiation)
- Change From Baseline in Withdrawal-Related Psychological Symptoms.(Baseline (on tirzepatide), 3-4 weeks of discontinuation, and 6-8 weeks of re-initiation)
- Change From Baseline in Sleep Quality as Measured by the Pittsburgh Sleep Quality Index(Baseline (on tirzepatide), 3-4 weeks of discontinuation, and 6-8 weeks of re-initiation)
- Change From Baseline in Addiction-Related Problem Severity(Baseline (on tirzepatide), 3-4 weeks of discontinuation, and 6-8 weeks of re-initiation)
- Change From Baseline in Substance Use Frequency and Quantity.(Baseline (on tirzepatide), 3-4 weeks of discontinuation, and 6-8 weeks of re-initiation)
- Change From Baseline in Risky and Impulsive Behavior.(Baseline (on tirzepatide), 3-4 weeks of discontinuation, and 6-8 weeks of re-initiation)
研究者
Dr. Francesca Filbey
Professor
The University of Texas at Dallas