A Randomized Clinical Trial to Determine the Effect of Dual Glucose-dependent Insulinotropic Polypeptide (GIP)/GLP-1 Receptor Agonist-mediated Weight Loss and Diet on Crohn's Disease Clinical Response: a Pilot Study
试验速览
- 阶段
- 4 期
- 状态
- 招募中
- 入组人数
- 24
- 试验地点
- 1
- 主要终点
- Change in percentage of participants retained
研究概览
简要总结
The purpose of this study is to use diet and an injectable medication called tirzepatide (Zepbound) glucose-dependent insulinotropic polypeptide and glucagon-like peptide-1 receptor agonist (GIP-GLP-1 RA) medication as adjunctive therapy (another treatment used together with the primary treatment) for Crohn's disease patients with mild disease who are on stable doses of biologic medication (infliximab or adalimumab) and who have a body mass index (BMI) of at least 27.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Supportive Care
- 盲法
- Single (Participant)
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
- •Adult patients (≥18 years old)
- •Confirmed diagnosis of Crohn's disease
- •Mildly active disease, defined by clinical symptoms using the Harvey Bradshaw Index (HBI) score between 5 and 7 (the HBI is a continuous score ranging from 0-16 where <4 is considered remission)
- •BMI ≥ 27 kg/m2
- •Patients will be on stable doses of medical therapy (anti-tumor necrosis factor (TNF) alpha blockers)
排除标准
- •Patients under 18 years of age
- •Patients with ulcerative colitis
- •Patients with infectious colitis
- •BMI<27 kg/m2
- •Patients with type 1 or type 2 diabetes
- •Contraindications to a GIP/GLP-1 RA, including patients with a personal or family history of medullary thyroid cancer or in patients with Multiple Endocrine Neoplasia syndrome type 2
- •Patients already on GIP/GLP-1 RA therapy
- •Patients with the following chronic symptoms: severe constipation, nausea, and/or vomiting
- •Patients with the following medical history: small bowel obstruction in the last year, intestinal stricture, known or suspected diagnosis of gastroparesis
- •Adults unable to consent
- •Pregnant patients (will be confirmed via a pregnancy test)
- •Prisoners
研究组 & 干预措施
Tirzepatide group
Participants will be in this group for up to 12 weeks.
干预措施: Tirzepatide (Drug)
Tirzepatide group
Participants will be in this group for up to 12 weeks.
干预措施: Mediterranean diet (Behavioral)
Mediterranean diet group
Participants will be in this group for up to 12 weeks.
干预措施: Mediterranean diet (Behavioral)
结局指标
主要结局
Change in percentage of participants retained
时间窗: Baseline, 12 weeks
The percentage of participants retained will be measured
Number of patients who adhere to diet measured by 24 hour dietary recall
时间窗: Up to 12 weeks
Number of patients who adhere to diet measured by 24 hour dietary recall
Number of patients who adhere to medications measured by self report
时间窗: Up to 12 weeks
Number of patients who adhere to medications measured by self report
次要结局
- Number of calls completed(Up to 12 weeks)
- Number of dietary recall (ASA24) surveys completed(Up to 12 weeks)
- Number of clinical symptom (HBI/CDAI) surveys completed(Up to 12 weeks)
- Number of blood samples completed(Up to 12 weeks)
- Number of stool samples completed(Up to 12 weeks)
研究者
Oriana Mazorra Damas
Associate Professor of Clinical Medicine
University of Miami