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.
연구 개요
상태
상세 설명
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).
연구 유형
등록 (추정된)
연락처 및 위치
연구 연락처
- 이름: Yaşar Bayındır, MD, Prof.
- 전화번호: +905323659909
- 이메일: yasar.bayindir@guven.com.tr
연구 장소
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Adana, 터키 (Türkiye)
- 모병
- Adana Acıbadem Hospital
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연락하다:
- Behice Kurtaran, MD, Prof.
- 전화번호: +905327393613
- 이메일: behicekurtaran@gmail.com
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수석 연구원:
- Behice Kurtaran, MD, Prof.
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Adana, 터키 (Türkiye)
- 모병
- Cukurova University, Faculty of Medicine
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연락하다:
- Yesim Tasova, MD, Prof.
- 전화번호: +905353088511
- 이메일: ytasova@gmail.com
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수석 연구원:
- Yesim Tasova, MD, Prof.
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Ankara, 터키 (Türkiye)
- 모병
- Hacettepe University, Faculty of Medicine
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연락하다:
- Ahmet Cagkan Inkaya, MD, Prof.
- 전화번호: +905326828702
- 이메일: inkaya@hacettepe.edu.tr
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수석 연구원:
- Ahmet Cagkan Inkaya, MD, Prof.
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부수사관:
- Nursel Calik Basaran, MD, Prof.
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부수사관:
- Meliha Cagla Sonmezer, MD, Assoc. Prof.
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Antalya, 터키 (Türkiye)
- 모병
- Akdeniz University, Faculty of Medicine
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연락하다:
- Dilara Inan, MD, Prof.
- 전화번호: +905323706725
- 이메일: inan@akdeniz.edu.tr
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수석 연구원:
- Dilara Inan, MD, Prof.
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Diyarbakır, 터키 (Türkiye), TR21280
- 모병
- Dicle University, Faculty of Medicine
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연락하다:
- Mustafa Kemal Celen, MD, Prof.
- 전화번호: +905336207022
- 이메일: mkcelen@hotmail.com
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수석 연구원:
- Mustafa Kemal Celen, MD, Prof.
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부수사관:
- Cigdem Mermutluoglu, MD, Assoc. Prof.
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Gaziantep, 터키 (Türkiye)
- 모병
- Gaziantep University, Faculty of Medicine
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연락하다:
- İlkay Karaoglan, MD, Prof.
- 전화번호: +905359266763
- 이메일: ilkayn.can@gmail.com
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수석 연구원:
- Ilkay Karaoglan, MD, Prof.
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부수사관:
- Ayse Ozlem Mete, MD, Assoc. Prof.
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Istanbul, 터키 (Türkiye)
- 모병
- Health Sciences University Hamidiye Faculty of Medicine
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연락하다:
- Funda Simsek, MD, Prof.
- 전화번호: +905325620953
- 이메일: fundasimsek67@gmail.com
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수석 연구원:
- Funda Simsek, MD, Prof.
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Izmir, 터키 (Türkiye)
- 모병
- Ege University, Faculty of Medicine
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연락하다:
- Husnu Pullukcu, MD, Prof.
- 전화번호: +905334231918
- 이메일: husnup@yahoo.com
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수석 연구원:
- Husnu Pullukcu, MD, Prof.
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Kocaeli, 터키 (Türkiye)
- 모병
- Kocaeli University, Faculty of Medicine
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연락하다:
- Sila Akhan, MD, Prof.
- 전화번호: +905322666535
- 이메일: sila.akhan@kocaeli.edu.tr
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수석 연구원:
- Sila Akhan, MD, Prof.
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Sanliurfa, 터키 (Türkiye)
- 모병
- Harran University, Faculty of Medicine
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연락하다:
- Tuba Damar Cakirca, MD, Assoc. Prof.
- 전화번호: +905444495379
- 이메일: dr.tubadamar@gmail.com
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수석 연구원:
- Tuba Damar Cakirca, MD, Assoc. Prof.
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Ankara
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Ankara, Ankara, 터키 (Türkiye), 06850
- 모병
- Guven Hospital
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연락하다:
- Yaşar Bayındır, MD, Prof.
- 전화번호: 05323659909
- 이메일: yasar.bayindir@guven.com.tr
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참여기준
자격 기준
공부할 수 있는 나이
- 성인
- 고령자
건강한 자원 봉사자를 받아들입니다
샘플링 방법
연구 인구
설명
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.
공부 계획
연구는 어떻게 설계됩니까?
디자인 세부사항
코호트 및 개입
그룹/코호트 |
개입 / 치료 |
|---|---|
|
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.
|
연구는 무엇을 측정합니까?
주요 결과 측정
결과 측정 |
측정값 설명 |
기간 |
|---|---|---|
|
Change in Hepatic Steatosis (CAP)
기간: 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)
기간: 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
|
공동 작업자 및 조사자
연구 기록 날짜
연구 주요 날짜
연구 시작 (실제)
기본 완료 (추정된)
연구 완료 (추정된)
연구 등록 날짜
최초 제출
QC 기준을 충족하는 최초 제출
처음 게시됨 (실제)
연구 기록 업데이트
마지막 업데이트 게시됨 (실제)
QC 기준을 충족하는 마지막 업데이트 제출
마지막으로 확인됨
추가 정보
이 연구와 관련된 용어
키워드
추가 관련 MeSH 약관
기타 연구 ID 번호
- CETA-2024-MASHIV-TR-001
개별 참가자 데이터(IPD) 계획
개별 참가자 데이터(IPD)를 공유할 계획입니까?
약물 및 장치 정보, 연구 문서
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