NCT07650149招募中不适用
OPTIMIZE GEN - Outcomes of Persistence and Treatment With tIrzepatide deterMined by Genetic, mIcrobiological & bEhavioral Factors in obEsity
Jan Kochanowski University2 个研究点 分布在 1 个国家目标入组 200 人开始时间: 2026年5月23日最近更新:
适应症
干预措施
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 发起方
- 入组人数
- 200
- 试验地点
- 2
- 主要终点
- weight change
研究概览
简要总结
This study will assess the impact of genetic markers, microbiological (microbiome) and behavioral factors on tolerance, adherence and effectiveness of dual GLP1/GIP RA in the treatment of obesity.
200 consecutive patients who meet all inclusion and none of the exclusion criteria will be enrolled.
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 60 Years（Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Age 18-60 years
- •Consent to participate in the study and providing informed written consent
- •Overweight or obese with a BMI >27
排除标准
- •Contraindications to tirzepatide use:
- •Type 1 or type 2 diabetes
- •Pregnancy or breastfeeding
- •Heart failure
- •Expected lack of patient compliance
- •Taking immunosuppressive medications, steroids, NSAIDs, antibiotics (within 2 weeks prior to sample collection),
- •Autoimmune and inflammatory diseases, acute infectious diseases, AIDS, tuberculosis
- •Mental illness
- •Alcohol dependence syndrome
- •Liver cirrhosis
- •Post-myocardial infarction or stroke
研究组 & 干预措施
patients with BMI>27
tirzepatide treatment
干预措施: gut microbiome (Diagnostic Test)
patients with BMI>27
tirzepatide treatment
干预措施: genetic polymorphism (Diagnostic Test)
结局指标
主要结局
weight change
时间窗: 1 and 6 months
weight change measured in kg and as BMI
次要结局
- treatment discontinuation(up to 6 months)
- adverse reactions(up to 6 months)
研究者
Zbigniew Siudak
Principal Investigator
Jan Kochanowski University
研究点 (2)
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