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Non-Invasive Hepatic and Metabolic Index Changes After Incretin Therapy in Overweight/Obesity (GLP-NIT)

2026年7月13日 更新者：Ayse N Erbakan、Goztepe Prof Dr Suleyman Yalcın City Hospital

Early Changes in Non-Invasive Hepatic and Metabolic Indices After Incretin-Based Therapy in Patients With Overweight or Obesity: Real-World Evidence From a Turkish Cohort

This single-center, retrospective observational cohort study evaluated early changes in non-invasive hepatic and metabolic indices (FIB-4, APRI, HSI, and the triglyceride-glucose [TyG] index) in adults with overweight or obesity who received once-weekly subcutaneous semaglutide or tirzepatide for metabolic risk reduction related to metabolic dysfunction-associated steatotic liver disease (MASLD). Baseline and follow-up (minimum 12 weeks) clinical, anthropometric, and laboratory data from 154 patients treated at a single tertiary-care center in Turkey were analyzed. The study assessed whether short-term incretin-based therapy was associated with changes in fibrosis-related indices (FIB-4, APRI) versus steatosis- and insulin resistance-related indices (HSI, TyG), and identified independent predictors of these changes using multivariable linear regression.

研究概览

地位

完全的

条件

干预/治疗

详细说明

Adults aged 18 years or older with overweight or obesity who were considered at increased metabolic risk for MASLD and who received continuous subcutaneous semaglutide or tirzepatide for at least 12 weeks were retrospectively identified at the internal medicine clinic of a tertiary-care state hospital in Istanbul, Turkey. Patients with significant alcohol consumption, other chronic liver disease etiologies, prior bariatric surgery, recent initiation/dose change of MASLD-relevant medications, concurrent hepatotoxic agent use, or missing baseline/follow-up data were excluded.

Baseline values were defined as the most recent measurements within 4 weeks before treatment initiation; follow-up values were the earliest measurements obtained after at least 12 continuous weeks of therapy. FIB-4, APRI, HSI, and TyG were calculated at both time points. Wilcoxon signed-rank tests compared baseline-to-follow-up changes. Kendall's tau assessed exploratory correlations among change scores; Spearman's rho assessed two prespecified correlations (percentage body-weight change vs. index changes; ΔHbA1c vs. index changes in the diabetic subgroup). Multivariable linear regression (enter method) identified independent predictors of ΔFIB-4, ΔAPRI, ΔHSI, and ΔTyG, adjusting for baseline index value, weight change, follow-up duration, baseline HbA1c, sex, and age.

Agent choice (semaglutide vs. tirzepatide) and dose titration were at the discretion of the treating physician; patients receiving either agent were analyzed together as a drug class, without dose-based stratification, since the study's aim was to characterize the class-level early index response rather than compare individual agents.

研究类型

观察性的

注册 (实际的)

154

联系人和位置

本节提供了进行研究的人员的详细联系信息，以及有关进行该研究的地点的信息。

学习地点

  • 土耳其（türkiye）
      • Istanbul、土耳其（türkiye）
        • Facility: Istanbul Medeniyet University, Göztepe Prof. Dr. Süleyman Yalçın City Hospital

参与标准

研究人员寻找符合特定描述的人，称为资格标准。这些标准的一些例子是一个人的一般健康状况或先前的治疗。

资格标准

适合学习的年龄

  • 成人
  • 年长者

接受健康志愿者

不

取样方法

非概率样本

研究人群

Adults with overweight or obesity at increased metabolic risk for MASLD, treated with subcutaneous semaglutide or tirzepatide for at least 12 weeks at a single tertiary-care internal medicine clinic in Turkey; both medications were self-funded (out-of-pocket), as they are not covered by the national health insurance system.

描述

Inclusion Criteria:

  • Adults aged 18 years or older
  • Overweight (BMI 25.0-29.9 kg/m²) or obesity (BMI ≥30.0 kg/m²)
  • Considered at increased metabolic risk for MASLD (overweight/obesity plus ≥1 additional cardiometabolic risk factor)
  • Continuous treatment with subcutaneous semaglutide or tirzepatide for at least 12 weeks

Exclusion Criteria:

  • Significant alcohol consumption (>30 g/day for men; >20 g/day for women)
  • Chronic liver disease of other etiology (viral hepatitis, autoimmune hepatitis, hemochromatosis, Wilson's disease)
  • Prior bariatric surgery
  • Initiation or dose modification of pioglitazone, SGLT-2 inhibitors, or high-dose vitamin E within 3 months before baseline
  • Concurrent use of known hepatotoxic agents (e.g., amiodarone, methotrexate)
  • Missing clinical, anthropometric, or laboratory data at baseline or follow-up

学习计划

本节提供研究计划的详细信息，包括研究的设计方式和研究的衡量标准。

研究是如何设计的？

设计细节

队列和干预

团体/队列
干预/治疗
Semaglutide
Adults with overweight or obesity at increased metabolic risk for MASLD who received continuous once-weekly subcutaneous semaglutide for at least 12 weeks (n=81). Dose titration was at the treating physician's discretion.
药品：Semaglutide
Once-weekly subcutaneous GLP-1 receptor agonist administered for at least 12 weeks; dose individualized and titrated at the treating physician's discretion according to routine clinical practice and patient tolerability.
其他名称：
  • Ozempic; Wegovy
Tirzepatide
Adults with overweight or obesity at increased metabolic risk for MASLD who received continuous once-weekly subcutaneous tirzepatide for at least 12 weeks (n=73). Dose titration was at the treating physician's discretion.
药品：Tirzepatide
Once-weekly subcutaneous dual GIP/GLP-1 receptor agonist administered for at least 12 weeks; dose individualized and titrated at the treating physician's discretion according to routine clinical practice and patient tolerability.
其他名称：
  • Mounjaro; Zepbound

研究衡量的是什么？

主要结果指标

结果测量
措施说明
大体时间
Change in Fibrosis-4 Index (FIB-4)
大体时间：Baseline and follow-up (median 23.7 weeks; minimum 12 weeks)
FIB-4 = (Age × AST) / (Platelet count × √ALT), calculated at baseline and after ≥12 weeks of therapy.
Baseline and follow-up (median 23.7 weeks; minimum 12 weeks)
Change in AST-to-Platelet Ratio Index (APRI)
大体时间：Baseline and follow-up (median 23.7 weeks; minimum 12 weeks)
APRI = (AST / 40 U/L ULN) / Platelet count × 100, calculated at baseline and after ≥12 weeks of therapy.
Baseline and follow-up (median 23.7 weeks; minimum 12 weeks)
Change in Hepatic Steatosis Index (HSI)
大体时间：Baseline and follow-up (median 23.7 weeks; minimum 12 weeks)
HSI = 8 × (ALT/AST) + BMI + 2 (if type 2 diabetes) + 2 (if female), calculated at baseline and after ≥12 weeks of therapy.
Baseline and follow-up (median 23.7 weeks; minimum 12 weeks)
Change in Triglyceride-Glucose (TyG) Index
大体时间：Baseline and follow-up (median 23.7 weeks; minimum 12 weeks)
yG = ln[fasting triglycerides (mg/dL) × fasting plasma glucose (mg/dL) / 2], calculated at baseline and after ≥12 weeks of therapy.
Baseline and follow-up (median 23.7 weeks; minimum 12 weeks)

次要结果测量

结果测量
措施说明
大体时间
Change in Liver Enzymes
大体时间：Baseline and follow-up (median 23.7 weeks)
AST, ALT, and GGT levels (U/L).
Baseline and follow-up (median 23.7 weeks)
Change in Lipid Profile
大体时间：Baseline and follow-up (median 23.7 weeks)
Total cholesterol, HDL-C, LDL-C, and triglycerides (mg/dL)
Baseline and follow-up (median 23.7 weeks)
Change in Fasting Plasma Glucose
大体时间：Baseline and follow-up (median 23.7 weeks)
Fasting plasma glucose (mg/dL)
Baseline and follow-up (median 23.7 weeks)
Change in Body Weight
大体时间：Baseline and follow-up (median 23.7 weeks)
Body weight (kilograms).
Baseline and follow-up (median 23.7 weeks)
Change in Glycated Hemoglobin (HbA1c)
大体时间：Baseline and follow-up (median 23.7 weeks)
HbA1c (percentage of total hemoglobin, %).
Baseline and follow-up (median 23.7 weeks)
Change in Body Mass Index (BMI)
大体时间：Baseline and follow-up (median 23.7 weeks)
BMI (kg/m^2), calculated from body weight and height.
Baseline and follow-up (median 23.7 weeks)
Change in Waist-to-Height Ratio
大体时间：Baseline and follow-up (median 23.7 weeks)
Waist-to-height ratio (unitless ratio: waist circumference [cm] / height [cm]).
Baseline and follow-up (median 23.7 weeks)

合作者和调查者

在这里您可以找到参与这项研究的人员和组织。

赞助

Goztepe Prof Dr Suleyman Yalcın City Hospital

调查人员

  • 首席研究员：Ozgur Bahadir, MD、Istanbul Medeniyet University, Faculty of Medicine, Department of Gastroenterology
  • 研究主任：Ayse N Erbakan, MD,PhD、Istanbul Medeniyet University, Faculty of Medicine, Department of Internal Medicine

研究记录日期

这些日期跟踪向 ClinicalTrials.gov 提交研究记录和摘要结果的进度。研究记录和报告的结果由国家医学图书馆 (NLM) 审查，以确保它们在发布到公共网站之前符合特定的质量控制标准。

研究主要日期

学习开始 (实际的)

2024年1月1日

初级完成 (实际的)

2026年3月30日

研究完成 (实际的)

2026年4月15日

研究注册日期

首次提交

2026年7月7日

首先提交符合 QC 标准的

2026年7月7日

首次发布 (实际的)

2026年7月14日

研究记录更新

最后更新发布 (实际的)

2026年7月15日

上次提交的符合 QC 标准的更新

2026年7月13日

最后验证

2026年7月1日

更多信息

与本研究相关的术语

关键字

其他相关的 MeSH 术语

其他研究编号

  • GLP-NIT

计划个人参与者数据 (IPD)

计划共享个人参与者数据 (IPD)？

不

IPD 计划说明

Data available from the corresponding author upon reasonable request

药物和器械信息、研究文件

研究美国 FDA 监管的药品

不

研究美国 FDA 监管的设备产品

不

此信息直接从 clinicaltrials.gov 网站检索，没有任何更改。如果您有任何更改、删除或更新研究详细信息的请求，请联系 register@clinicaltrials.gov. clinicaltrials.gov 上实施更改，我们的网站上也会自动更新.

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