Metabolic Liver Disease in Newly Diagnosed People Living With HIV (MASHIV-TR) (MASHIV-TR)
Metabolic Liver Disease in Newly Diagnosed People Living With HIV: MASHIV-TR Cohort (MASHIV-TR)
This study aims to identify the risk factors that lead to the development of metabolic liver disease in people who have been newly diagnosed with HIV. The research will take place across 9 centers in Türkiye and plans to include 250 newly diagnosed individuals with HIV, alongside 161 healthy individuals without HIV as a control group.
Participants will have their liver health checked when they first join the study (baseline) and then once a year for up to 5 years (at 12, 24, 36, 48, and 60 months). The main goal of these visits is to monitor their metabolic health and understand who is at risk of developing a fatty liver condition known as MASLD (Metabolic dysfunction-Associated Steatotic Liver Disease).
During each visit, the research team will collect information about the participants' general health, including their height, weight, medical and family history, lifestyle habits, and sleep patterns. They will also record any medications being taken, including HIV treatments. To thoroughly check liver health, researchers will use routine blood tests (measuring things like cholesterol, blood sugar, and kidney function) and painless, non-invasive imaging tests, such as ultrasounds and FibroScans, to measure liver fat and stiffness.
調査の概要
状態
詳細な説明
Background and Rationale:
The prospective determination of risk factors associated with the development of metabolic liver disease is of critical clinical importance, particularly in newly diagnosed People Living with HIV (PLWH). This multi-center, prospective, observational cohort study aims to identify and monitor the risk factors contributing to the development of Metabolic dysfunction-Associated Steatotic Liver Disease (MASLD) in newly diagnosed PLWH, compared to an HIV-negative healthy control group.
Study Design and Population:
The study will be conducted across 9 centers in Turkey (Adana, Ankara, Antalya, Diyarbakır, Gaziantep, İstanbul, İzmir, Kocaeli, and Şanlıurfa). The targeted enrollment is a total of 411 participants, consisting of 250 newly diagnosed HIV-positive individuals and 161 HIV-negative healthy controls.
Methodology and Follow-up:
Participants in both the patient and control groups will undergo comprehensive clinical, laboratory, and radiological evaluations at the time of diagnosis (baseline) and subsequently every 12 months for a total follow-up period of 5 years (60 months). By longitudinally tracking metabolic, anthropometric, and hepatic parameters, the study will map the incidence of MASLD and stratify the metabolic risk factors over time.
Clinical Assessments (Conducted at Baseline, 12, 24, 36, 48, and 60 months):
To ensure standardization across all follow-up visits, the following parameters will be uniformly evaluated at every study time point:
Demographic and Clinical Characteristics: BMI (Height and Weight), comprehensive medical history, family history, presence of comorbidities, current medications, lifestyle habits, alcohol and substance use, and sleep patterns.
HIV-Specific Parameters: Details of the initiated Antiretroviral Therapy (ART) regimen.
Laboratory Parameters: Fasting glucose, HOMA-IR score, Lipid profile (Total Cholesterol, Triglycerides, LDL, HDL, LDL/HDL ratio, VLDL), Renal function tests (GFR, creatinine, urea, proteinuria), and systemic/hepatic markers (CRP, AFP, INR, FIB-4 index).
Radiological and Non-Invasive Hepatic Evaluations: Hepatobiliary ultrasonography (USG) and FibroScan measurements (recording both Controlled Attenuation Parameter (CAP) and Liver Stiffness Measurement (LSM) values).
研究の種類
入学 (推定)
連絡先と場所
研究連絡先
- 名前：Yaşar Bayındır, MD, Prof.
- 電話番号：+905323659909
- メール：yasar.bayindir@guven.com.tr
研究場所
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Adana、トルコ（Türkiye）
- 募集
- Adana Acıbadem Hospital
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コンタクト：
- Behice Kurtaran, MD, Prof.
- 電話番号：+905327393613
- メール：behicekurtaran@gmail.com
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主任研究者：
- Behice Kurtaran, MD, Prof.
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Adana、トルコ（Türkiye）
- 募集
- Cukurova University, Faculty of Medicine
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コンタクト：
- Yesim Tasova, MD, Prof.
- 電話番号：+905353088511
- メール：ytasova@gmail.com
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主任研究者：
- Yesim Tasova, MD, Prof.
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Ankara、トルコ（Türkiye）
- 募集
- Hacettepe University, Faculty of Medicine
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コンタクト：
- Ahmet Cagkan Inkaya, MD, Prof.
- 電話番号：+905326828702
- メール：inkaya@hacettepe.edu.tr
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主任研究者：
- Ahmet Cagkan Inkaya, MD, Prof.
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副調査官：
- Nursel Calik Basaran, MD, Prof.
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副調査官：
- Meliha Cagla Sonmezer, MD, Assoc. Prof.
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Antalya、トルコ（Türkiye）
- 募集
- Akdeniz University, Faculty of Medicine
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コンタクト：
- Dilara Inan, MD, Prof.
- 電話番号：+905323706725
- メール：inan@akdeniz.edu.tr
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主任研究者：
- Dilara Inan, MD, Prof.
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Diyarbakır、トルコ（Türkiye）、TR21280
- 募集
- Dicle University, Faculty of Medicine
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コンタクト：
- Mustafa Kemal Celen, MD, Prof.
- 電話番号：+905336207022
- メール：mkcelen@hotmail.com
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主任研究者：
- Mustafa Kemal Celen, MD, Prof.
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副調査官：
- Cigdem Mermutluoglu, MD, Assoc. Prof.
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Gaziantep、トルコ（Türkiye）
- 募集
- Gaziantep University, Faculty of Medicine
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コンタクト：
- İlkay Karaoglan, MD, Prof.
- 電話番号：+905359266763
- メール：ilkayn.can@gmail.com
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主任研究者：
- Ilkay Karaoglan, MD, Prof.
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副調査官：
- Ayse Ozlem Mete, MD, Assoc. Prof.
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Istanbul、トルコ（Türkiye）
- 募集
- Health Sciences University Hamidiye Faculty of Medicine
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コンタクト：
- Funda Simsek, MD, Prof.
- 電話番号：+905325620953
- メール：fundasimsek67@gmail.com
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主任研究者：
- Funda Simsek, MD, Prof.
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Izmir、トルコ（Türkiye）
- 募集
- Ege University, Faculty of Medicine
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コンタクト：
- Husnu Pullukcu, MD, Prof.
- 電話番号：+905334231918
- メール：husnup@yahoo.com
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主任研究者：
- Husnu Pullukcu, MD, Prof.
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Kocaeli、トルコ（Türkiye）
- 募集
- Kocaeli University, Faculty of Medicine
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コンタクト：
- Sila Akhan, MD, Prof.
- 電話番号：+905322666535
- メール：sila.akhan@kocaeli.edu.tr
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主任研究者：
- Sila Akhan, MD, Prof.
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Sanliurfa、トルコ（Türkiye）
- 募集
- Harran University, Faculty of Medicine
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コンタクト：
- Tuba Damar Cakirca, MD, Assoc. Prof.
- 電話番号：+905444495379
- メール：dr.tubadamar@gmail.com
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主任研究者：
- Tuba Damar Cakirca, MD, Assoc. Prof.
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Ankara
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Ankara、Ankara、トルコ（Türkiye）、06850
- 募集
- Guven Hospital
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コンタクト：
- Yaşar Bayındır, MD, Prof.
- 電話番号：05323659909
- メール：yasar.bayindir@guven.com.tr
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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 (For the Patient Group / Newly Diagnosed HIV+):
- Citizens of the Republic of Türkiye
- Adults (≥ 18 years of age)
- Confirmed Anti-HIV positive (Newly diagnosed)
- Patients who are initiating Antiretroviral Therapy (ART)
Inclusion Criteria (For the Healthy Control Group / HIV-):
- Citizens of the Republic of Türkiye
- Adults (≥ 18 years of age)
- Confirmed Anti-HIV negative
Exclusion Criteria:
- There are no specified exclusion criteria for this study.
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 |
|---|---|
|
Newly Diagnosed HIV Patients
250 individuals newly diagnosed with HIV who are initiating Antiretroviral Therapy (ART).
This group will be prospectively monitored for the development of metabolic liver disease and MASLD risk factors over 60 months.
|
Non-invasive measurement of liver stiffness (LSM) and controlled attenuation parameter (CAP) to evaluate liver fibrosis and steatosis.
Measurements are taken at baseline and annually up to 60 months.
Routine ultrasound imaging of the liver and biliary tract to evaluate signs of metabolic liver disease and fatty liver.
Assessed at baseline and annually up to 60 months.
Annual monitoring including anthropometric measurements (BMI), lipid profile, fasting glucose, HOMA-IR score, renal and liver function tests, and calculation of the FIB-4 index.
For the patient group, details of the initiated Antiretroviral Therapy (ART) will also be recorded.
|
|
Healthy Controls
161 healthy individuals without an HIV diagnosis.
This group will serve as the comparative control group and will undergo the same prospective metabolic and hepatic evaluations over 60 months.
|
Non-invasive measurement of liver stiffness (LSM) and controlled attenuation parameter (CAP) to evaluate liver fibrosis and steatosis.
Measurements are taken at baseline and annually up to 60 months.
Routine ultrasound imaging of the liver and biliary tract to evaluate signs of metabolic liver disease and fatty liver.
Assessed at baseline and annually up to 60 months.
Annual monitoring including anthropometric measurements (BMI), lipid profile, fasting glucose, HOMA-IR score, renal and liver function tests, and calculation of the FIB-4 index.
For the patient group, details of the initiated Antiretroviral Therapy (ART) will also be recorded.
|
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 |
|---|---|---|
|
Change in Hepatic Steatosis (CAP)
時間枠：Baseline, 12, 24, 36, 48, and 60 months
|
The development and progression of hepatic steatosis will be quantitatively assessed using FibroScan to record the Controlled Attenuation Parameter (CAP, measured in dB/m).
Changes in CAP values will be compared between newly diagnosed HIV patients and healthy controls.
|
Baseline, 12, 24, 36, 48, and 60 months
|
|
Change in Liver Fibrosis (LSM)
時間枠：Baseline, 12, 24, 36, 48, and 60 months
|
The development and progression of liver fibrosis will be quantitatively assessed using FibroScan to record the Liver Stiffness Measurement (LSM, measured in kPa).
Changes in LSM values will be compared between newly diagnosed HIV patients and healthy controls.
|
Baseline, 12, 24, 36, 48, and 60 months
|
協力者と研究者
研究記録日
主要日程の研究
研究開始 (実際)
一次修了 (推定)
研究の完了 (推定)
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
- CETA-2024-MASHIV-TR-001
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?
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