Non-Invasive Hepatic and Metabolic Index Changes After Incretin Therapy in Overweight/Obesity (GLP-NIT)
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
調査の概要
詳細な説明
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.
研究の種類
入学 (実際)
連絡先と場所
研究場所
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Istanbul、トルコ（Türkiye）
- Facility: Istanbul Medeniyet University, Göztepe Prof. Dr. Süleyman Yalçın City Hospital
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参加基準
適格基準
就学可能な年齢
- 大人
- 高齢者
健康ボランティアの受け入れ
サンプリング方法
調査対象母集団
説明
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
研究計画
研究はどのように設計されていますか？
デザインの詳細
コホートと介入
グループ/コホート |
介入・治療 |
|---|---|
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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.
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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.
他の名前：
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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.
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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.
他の名前：
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この研究は何を測定していますか？
主要な結果の測定
結果測定 |
メジャーの説明 |
時間枠 |
|---|---|---|
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Change in Fibrosis-4 Index (FIB-4)
時間枠：Baseline and follow-up (median 23.7 weeks; minimum 12 weeks)
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FIB-4 = (Age × AST) / (Platelet count × √ALT), calculated at baseline and after ≥12 weeks of therapy.
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Baseline and follow-up (median 23.7 weeks; minimum 12 weeks)
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Change in AST-to-Platelet Ratio Index (APRI)
時間枠：Baseline and follow-up (median 23.7 weeks; minimum 12 weeks)
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APRI = (AST / 40 U/L ULN) / Platelet count × 100, calculated at baseline and after ≥12 weeks of therapy.
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Baseline and follow-up (median 23.7 weeks; minimum 12 weeks)
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Change in Hepatic Steatosis Index (HSI)
時間枠：Baseline and follow-up (median 23.7 weeks; minimum 12 weeks)
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HSI = 8 × (ALT/AST) + BMI + 2 (if type 2 diabetes) + 2 (if female), calculated at baseline and after ≥12 weeks of therapy.
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Baseline and follow-up (median 23.7 weeks; minimum 12 weeks)
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Change in Triglyceride-Glucose (TyG) Index
時間枠：Baseline and follow-up (median 23.7 weeks; minimum 12 weeks)
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yG = ln[fasting triglycerides (mg/dL) × fasting plasma glucose (mg/dL) / 2], calculated at baseline and after ≥12 weeks of therapy.
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Baseline and follow-up (median 23.7 weeks; minimum 12 weeks)
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二次結果の測定
結果測定 |
メジャーの説明 |
時間枠 |
|---|---|---|
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Change in Liver Enzymes
時間枠：Baseline and follow-up (median 23.7 weeks)
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AST, ALT, and GGT levels (U/L).
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Baseline and follow-up (median 23.7 weeks)
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Change in Lipid Profile
時間枠：Baseline and follow-up (median 23.7 weeks)
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Total cholesterol, HDL-C, LDL-C, and triglycerides (mg/dL)
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Baseline and follow-up (median 23.7 weeks)
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Change in Fasting Plasma Glucose
時間枠：Baseline and follow-up (median 23.7 weeks)
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Fasting plasma glucose (mg/dL)
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Baseline and follow-up (median 23.7 weeks)
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Change in Body Weight
時間枠：Baseline and follow-up (median 23.7 weeks)
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Body weight (kilograms).
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Baseline and follow-up (median 23.7 weeks)
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Change in Glycated Hemoglobin (HbA1c)
時間枠：Baseline and follow-up (median 23.7 weeks)
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HbA1c (percentage of total hemoglobin, %).
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Baseline and follow-up (median 23.7 weeks)
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Change in Body Mass Index (BMI)
時間枠：Baseline and follow-up (median 23.7 weeks)
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BMI (kg/m^2), calculated from body weight and height.
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Baseline and follow-up (median 23.7 weeks)
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Change in Waist-to-Height Ratio
時間枠：Baseline and follow-up (median 23.7 weeks)
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Waist-to-height ratio (unitless ratio: waist circumference [cm] / height [cm]).
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Baseline and follow-up (median 23.7 weeks)
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協力者と研究者
捜査官
- 主任研究者：Ozgur Bahadir, MD、Istanbul Medeniyet University, Faculty of Medicine, Department of Gastroenterology
- スタディディレクター：Ayse N Erbakan, MD,PhD、Istanbul Medeniyet University, Faculty of Medicine, Department of Internal Medicine
研究記録日
主要日程の研究
研究開始 (実際)
一次修了 (実際)
研究の完了 (実際)
試験登録日
最初に提出
QC基準を満たした最初の提出物
最初の投稿 (実際)
学習記録の更新
投稿された最後の更新 (実際)
QC基準を満たした最後の更新が送信されました
最終確認日
詳しくは
本研究に関する用語
キーワード
追加の関連 MeSH 用語
その他の研究ID番号
- GLP-NIT
個々の参加者データ (IPD) の計画
個々の参加者データ (IPD) を共有する予定はありますか?
IPD プランの説明
医薬品およびデバイス情報、研究文書
米国FDA規制医薬品の研究
米国FDA規制機器製品の研究
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