Association Between Overt and Sub-clinical Primary Hypothyroidism and Metabolic Dysfunction-Associated Steatoic Liver Disease in Non-Diabetic Patients
2026年5月30日 更新者：Islam Khaled Fathy、Sohag University
Association Between Overt and Sub-clinical Primary Hypothyroidism and Metabolic Dysfunction-Associated Steatoic Liver Disease (MASLD) in Non-Diabetic Patients
This study aims to estimate the prevalence of Metabolic dysfunction - associated Steatoic liver disease (MASLD) among adults with primary hypothyroidism (overt or sub-clinical 1ry hypothyroidism) and prevalence of MASLD in Hashimoto-thyroiditis vs Euthyroid controls in non-diabetic patients.
調査の概要
状態
募集
詳細な説明
Metabolic dysfunction - associated Steatoic liver disease (MASLD), previously known as non-alcoholic fatty liver disease (NAFLD), has become the leading cause of chronic liver disease globally.
Metabolic dysfunction -associated Steatoic liver disease (MASLD) is the prevailing chronic hepatic disorder, where it is characterized by hepatic steatosis affecting more than 5% of hepatocyte in absence of excessive alcohol consumption (> 30g/ day for men and >20g/day for women), or other underlying chronic liver diseases, and it is commonly associated metabolic risk factors such as obesity and type 2 diabetes.
Hypothyroidism is characterized by the reduction or absence of thyroid hormones.it can be manifest at birth as (congenital) or develop later (acquired). The most common cause of hypothyroidism is primary hypothyroidism due to dysfunction of the thyroid gland.
Overt hypothyroidism is a prevalent clinical thyroid disorder characterized by elevated serum thyrotropin (TSH) levels as well as reduced free thyroxine (FT4) levels.
研究の種類
観察的
入学 (推定)
200
連絡先と場所
このセクションには、調査を実施する担当者の連絡先の詳細と、この調査が実施されている場所に関する情報が記載されています。
研究連絡先
- 名前：Islam K Fathy, MSc
- 電話番号：00201011456295
- メール：islam.ali2@med.sohag.edu.eg
研究場所
-
-
Sohag Governorate
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Sohag、Sohag Governorate、エジプト、82511
- 募集
- Sohag University
-
コンタクト：
- Islam K Fathy, MSc
- 電話番号：00201011456295
- メール：islam.ali2@med.sohag.edu.eg
-
副調査官：
- Nayel A Zaki, MD
-
副調査官：
- Amal K Ahmed, MD
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副調査官：
- Ahmed N Nour Eldin, MD
-
-
参加基準
研究者は、適格基準と呼ばれる特定の説明に適合する人を探します。これらの基準のいくつかの例は、人の一般的な健康状態または以前の治療です。
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
いいえ
サンプリング方法
非確率サンプル
調査対象母集団
The patient population for the trial will be derived from Sohag University hospital/ Endocrine or Hepatology outpatient clinic.
The study protocol will be approved by the Ethics Committee of Sohag Faculty of Medicine.
説明
Inclusion Criteria:
- Patients aged ≥18years old who will be:
- Diagnosed with primary hypothyroidism (overt or sub clinical hypothyroidism) within 3 months with or without levothyroxine treatment.
- Patients with positive antibody (positive TPO antibody or positive Thyroglobin antibody) irrespective of thyroid status
- Metabolic dysfunction-associated steatotic liver disease (MASLD) assessment by ultrasound and Fibro-scan.
Exclusion Criteria:
- Diabetic patients according to American Diabetes Association (ADA) Criteria.
- Excessive Alcohol consumption (> 30 gm/ day in men, 20 gm /day in women.
- Body mass index (BMI) index >40 kg/m2
- Other causes of chronic hepatic steatosis [e.g., positive hepatitis B virus (HBV), positive hepatitis C virus (HCV)), autoimmune disease, Wilson disease, drugs].
- Patients use of drugs known to cause hepatic steatosis (e.g., amiodarone, valproate, tamoxifen, methotrexate, steroids).
- Treatment with drugs that influence liver fat, as thiazolidinediones, α-glucosidase inhibitors, sodium-glucose -transporter 2 (SGLT2) inhibitors or any glucagon-like peptide-1 receptor agonists during the previous 3 months.
- Detection of biliary duct obstruction based on imaging studies.
- Evidence of cirrhosis [on basis of ultrasonography and magnetic resonance imaging (MRI )] or hepatocellular carcinoma [evidence on triphasic Computed Tomography (CT) or MRI].
- Presence of any systemic disease that commonly cause liver disease.
- Severe hepatic injury and/or significant abnormal liver function defined as aspartate aminotransferase >5× upper limit of normal (ULN) and/or alanine aminotransferase >5× ULN or elevated total bilirubin > 2 mg/dl.
- Pregnant women.
- Patients with active malignancy.
- History of bariatric surgery or ongoing weight-loss diet (hypocaloric diet) or use of weight-loss agents unless the diet or treatment has been stopped at least 3 months before screening and that the patient has had a stable body weight (+/- 3 kg) during the 3 months before screening.
研究計画
このセクションでは、研究がどのように設計され、研究が何を測定しているかなど、研究計画の詳細を提供します。
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 |
|---|---|
|
Control Euthyroid group
Participants whom thyroid function tests are normal and screened for Metabolic dysfunction - associated Steatoic liver disease (MASLD).
|
Participants will undergo assessment of thyroid function status and evaluation for metabolic dysfunction-associated steatotic liver disease (MASLD) using laboratory investigations, abdominal ultrasonography, and vibration-controlled transient elastography (FibroScan).
Participants will undergo assessment of thyroid function status and evaluation for metabolic dysfunction-associated steatotic liver disease (MASLD) using laboratory investigations, abdominal ultrasonography, and vibration-controlled transient elastography (FibroScan).
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Case group-1
Patients with overt primary hypothyroidism (High TSH and low FT4, FT3) that screening for Metabolic dysfunction - associated Steatoic liver disease (MASLD).
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Participants will undergo assessment of thyroid function status and evaluation for metabolic dysfunction-associated steatotic liver disease (MASLD) using laboratory investigations, abdominal ultrasonography, and vibration-controlled transient elastography (FibroScan).
Participants will undergo assessment of thyroid function status and evaluation for metabolic dysfunction-associated steatotic liver disease (MASLD) using laboratory investigations, abdominal ultrasonography, and vibration-controlled transient elastography (FibroScan).
|
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Case group-2
Patients with sub clinical hypothyroidism (High TSH and normal FT4, FT3) and screened for Metabolic dysfunction - associated Steatoic liver disease (MASLD).
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Participants will undergo assessment of thyroid function status and evaluation for metabolic dysfunction-associated steatotic liver disease (MASLD) using laboratory investigations, abdominal ultrasonography, and vibration-controlled transient elastography (FibroScan).
Participants will undergo assessment of thyroid function status and evaluation for metabolic dysfunction-associated steatotic liver disease (MASLD) using laboratory investigations, abdominal ultrasonography, and vibration-controlled transient elastography (FibroScan).
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Case group-3
Patients with positive thyroid auto-antibodies (normal TSH, normal FT4, normal FT3, Positive TPo antibody or positive thyroglobin antibody) screened for Metabolic dysfunction - associated Steatoic liver disease (MASLD).
|
Participants will undergo assessment of thyroid function status and evaluation for metabolic dysfunction-associated steatotic liver disease (MASLD) using laboratory investigations, abdominal ultrasonography, and vibration-controlled transient elastography (FibroScan).
Participants will undergo assessment of thyroid function status and evaluation for metabolic dysfunction-associated steatotic liver disease (MASLD) using laboratory investigations, abdominal ultrasonography, and vibration-controlled transient elastography (FibroScan).
|
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 |
|---|---|---|
|
Assessment of the prevalence of metabolic dysfunction-associated steatotic liver disease
時間枠：3 months after the procedure
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Prevalence of metabolic dysfunction-associated steatotic liver disease (MASLD) diagnosed by abdominal ultrasonography/FibroScan among adults with primary hypothyroidism will be assessed.
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3 months after the procedure
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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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Correlation between severity of primary hypothyroidism and the degree of hepatic steatosis
時間枠：3 months after the procedure
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Correlation between severity of primary hypothyroidism [measured by Thyroid-stimulating hormone (TSH) levels] and the degree of hepatic steatosis [measured by Controlled Attenuation Parameter (CAP) score] will be recorded.
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3 months after the procedure
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Correlation between Hashimoto thyroiditis and metabolic dysfunction-associated steatotic liver disease
時間枠：3 months after the procedure
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Correlation between Hashimoto thyroiditis and metabolic dysfunction-associated steatotic liver disease will be recorded.
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3 months after the procedure
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協力者と研究者
ここでは、この調査に関係する人々や組織を見つけることができます。
スポンサー
研究記録日
これらの日付は、ClinicalTrials.gov への研究記録と要約結果の提出の進捗状況を追跡します。研究記録と報告された結果は、国立医学図書館 (NLM) によって審査され、公開 Web サイトに掲載される前に、特定の品質管理基準を満たしていることが確認されます。
主要日程の研究
研究開始 (実際)
2026年3月1日
一次修了 (推定)
2027年3月1日
研究の完了 (推定)
2027年3月1日
試験登録日
最初に提出
2026年5月16日
QC基準を満たした最初の提出物
2026年5月21日
最初の投稿 (実際)
2026年5月22日
学習記録の更新
投稿された最後の更新 (実際)
2026年6月2日
QC基準を満たした最後の更新が送信されました
2026年5月30日
最終確認日
2026年5月1日
詳しくは
本研究に関する用語
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?
はい
IPD プランの説明
The data will be available upon a reasonable request from the corresponding author after the end of study for one year.
IPD 共有時間枠
After the end of study for one year.
IPD 共有アクセス基準
The data will be available upon a reasonable request from the corresponding author.
IPD 共有サポート情報タイプ
- STUDY_PROTOCOL
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
いいえ
米国FDA規制機器製品の研究
いいえ
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