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临床试验/NCT07343726
NCT07343726尚未招募不适用

Impact of Obesity on Response to Therapy and Clinical Outcom in Patients With Inflammatory Bowel Disease

Assiut University0 个研究点目标入组 120 人开始时间: 2026年2月1日最近更新:

试验速览

阶段
不适用
状态
尚未招募
入组人数
120
主要终点
improvement rate of patients

研究概览

简要总结

Inflammatory Bowel Disease (IBD), which includes ulcerative colitis (UC) and Crohn's disease (CD), is a group of chronic relapsing inflammatory disorders of the gastrointestinal tract. Its pathogenesis is multifactorial, involving genetic predisposition, environmental triggers, immune dysregulation, and microbial imbalance. IBD has significant morbidity and a major impact on quality of life, with varied clinical presentations and disease behavior (1,2).

Obesity, defined as excessive body fat accumulation, is increasingly prevalent worldwide. It is now recognized as a state of chronic low-grade systemic inflammation due to adipose tissue secreting pro-inflammatory cytokines such as TNF-α and IL-6 (3,4). These cytokines may interact with pathways relevant to IBD, particularly in altering the immune response and intestinal inflammation (5).

recent studies suggest that obese IBD patients may experience a different disease phenotype, increased complications, and lower response rates to certain biologics, especially anti-TNF agents (6,7). In addition, obesity can alter drug pharmacokinetics, leading to reduced drug efficacy (8,9).

Despite increasing evidence of this association, there is limited local data evaluating the prevalence of obesity in IBD and its impact on treatment response and disease outcome (10,11). Understanding this link could help improve personalized treatment approaches and predict treatment outcomes in IBD patients (12,13).

Obesity has emerged as a modifiable factor that may influence the clinical response to therapy in patients with inflammatory bowel disease (IBD). Recent studies have shown that higher body mass index (BMI) is associated with reduced steroid-free clinical remission rates in patients treated with advanced biologic and small molecule therapies. The inflammatory nature of adipose tissue, altered pharmacokinetics, and increased drug clearance in obese individuals might explain the suboptimal therapeutic outcomes observed in this population

研究设计

研究类型
Observational
观察模型
Cohort
时间视角
Prospective

入排标准

年龄范围
18 Years 至 —(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • Adults (>18 years) diagnosed with IBD
  • Currently receiving standard treatment (including biologics)

排除标准

  • Patients with other causes of colitis (e.g. infectious, ischemic)
  • Pregnant females
  • Incomplete clinical or follow-up data

研究组 & 干预措施

obese patients

obese patients who have BMI ≥ 30

non-obese patients

non-obese patients who have BMI < 30

结局指标

主要结局

improvement rate of patients

时间窗: 3 months

Clinical response to treatment

次要结局

未报告次要终点

研究者

申办方类型
Other
责任方
Principal Investigator
主要研究者

Aya Ahmed Mahmoud Abdelmohsen

residant doctor at Assiut university hospital

Assiut University

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