AR, IGF-IR, IR and Peripheral Artery Disease (ANIMALPAD)
The Influence of Androgen Receptor, Insulin Like Growth Factor 1 Receptor, and Insulin Receptor in Male Patients With Peripheral Artery Disease
調査の概要
状態
詳細な説明
Peripheral artery disease (PAD) of lower limbs is one of the most common clinical manifestation of atherosclerosis and can be considered a major cardiovascular disease with important morbidity and mortality, affecting also quality of life (QoL), thus representing an important public health concern. From a clinical point of view, PAD may be initially symptomatic with intermittent claudication (IC), and in critical limb ischemia (CLI), an advanced stage of PAD, with rest pain, and also with leg skin ulceration, a complication that may even lead to limb loss for amputation. From a pathophysiological point of view, in the presence of atherosclerosis, endothelial activation and dysfunction lead to hemodynamic alterations such as turbulent flow, abnormal shear stress, loss of potential energy, anomalies of vascular tone with functional impairment during leg exercise in early stages, with IC onset, and in advanced stages, during CLI stage, also with rest pain as a result of an important demand/perfusion mismatch. Endothelial dysfunction, and vascular tone are also regulated by sex hormones, and incidence and prevalence of PAD have usually been found to be higher in men than in women, and, more in general, males have a higher risk of developing cardiovascular disease during the reproductive period in comparison with females of the same age. This sex related difference in developing the disease was hypothesized to be related to the protective role of estrogens in female subjects, and harmful effects of androgens in male individuals. Furthermore, the androgen receptor (AR) seems to have a role in neointima formation, in influencing the size and the composition of atherosclerotic plaques, and also vascular smooth muscle cells (VSMCs) activity. Moreover, sex-specific effects on the metabolic system are well-known and associated with different risk profiles for cardiovascular disease and they have been also related to differences in sex hormones activities. In fact, the insulin and IGF-I signaling is mediated by hormone interaction with the insulin receptor (IR) and the IGF-I receptor (IGF-IR) which are members of subclass II of the tyrosine kinase receptor super-family and they, on one hand, participate to the metabolic homeostasis, and on the other hand, they have a direct role on VMMCs, and also in some stages of the atherosclerotic process..
The aim of this study is to evaluate the role of AR, IGF-IR, and IR on the arterial wall of male patients with PAD undergoing open revascularization surgery.
研究の種類
入学 (予想される)
連絡先と場所
研究場所
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Catanzaro、イタリア、88100
- 募集
- University Magna Graecia of Catanzaro
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参加基準
適格基準
就学可能な年齢
健康ボランティアの受け入れ
受講資格のある性別
サンプリング方法
調査対象母集団
説明
Inclusion Criteria:
- Male patients with peripheral artery disease (PAD) eligible to receive arterial reconstructive open surgery.
Exclusion Criteria:
- active malignancy
- advanced liver disease
- advanced heart disease
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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Male patients with PAD
The cohort was built to collect information about the role of androgen receptor, insulin receptor and Insulin-like Growth Factor 1 Receptor (IGF-IR) expression in patients with peripheral artery disease referred to Vascular Surgeon Specialist.
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Patients with peripheral artery disease (PAD) will undergo arterial reconstructive open surgery.
Samples obtained from diseased arteries of lower limbs of patients undergoing arterial reconstructive open surgery will be collected and immediately preserved at -80°.
Briefly, arterial tissues were excised, homogenized using a motor driven homogenizer and total RNA was isolated using Trizol reagent (Invitrogen, Milan, Italy), in accordance with the manufacturer's instructions.
The expression of Androgen Receptor (AR), insulin receptor (IR) and the IGF-I receptor (IGF-IR) will be quantified by real-time PCR using platform Quant Studio7 Flex Real-Time PCR System (Thermo Fisher Scientific, Milan, Italy), following the manufacturer's instructions.
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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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Expression of AR, IGF-IR, IR
時間枠:at 1year
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The expression of IR, IGF-IR and AR was quantified by real-time PCR using platform Quant Studio7 Flex Real-Time PCR System (Thermo Fisher Scientific, Milan, Italy), following the manufacturer's instructions
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at 1year
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協力者と研究者
スポンサー
捜査官
- スタディチェア:Marcello Maggiolini, M.D.、UNICAL - University of Calabria
出版物と役立つリンク
一般刊行物
- Song P, Rudan D, Zhu Y, Fowkes FJI, Rahimi K, Fowkes FGR, Rudan I. Global, regional, and national prevalence and risk factors for peripheral artery disease in 2015: an updated systematic review and analysis. Lancet Glob Health. 2019 Aug;7(8):e1020-e1030. doi: 10.1016/S2214-109X(19)30255-4.
- Ielapi N, Licastro N, Catana M, Bracale UM, Serra R. Vascular Nursing and Vascular Surgery. Ann Vasc Surg. 2020 Oct;68:522-526. doi: 10.1016/j.avsg.2020.05.038. Epub 2020 May 29.
- Orshal JM, Khalil RA. Gender, sex hormones, and vascular tone. Am J Physiol Regul Integr Comp Physiol. 2004 Feb;286(2):R233-49. doi: 10.1152/ajpregu.00338.2003.
- Chistiakov DA, Myasoedova VA, Melnichenko AA, Grechko AV, Orekhov AN. Role of androgens in cardiovascular pathology. Vasc Health Risk Manag. 2018 Oct 15;14:283-290. doi: 10.2147/VHRM.S173259. eCollection 2018.
- Baars A, Oosting A, Lohuis M, Koehorst M, El Aidy S, Hugenholtz F, Smidt H, Mischke M, Boekschoten MV, Verkade HJ, Garssen J, van der Beek EM, Knol J, de Vos P, van Bergenhenegouwen J, Fransen F. Sex differences in lipid metabolism are affected by presence of the gut microbiota. Sci Rep. 2018 Sep 7;8(1):13426. doi: 10.1038/s41598-018-31695-w.
- Beneit N, Fernandez-Garcia CE, Martin-Ventura JL, Perdomo L, Escribano O, Michel JB, Garcia-Gomez G, Fernandez S, Diaz-Castroverde S, Egido J, Gomez-Hernandez A, Benito M. Expression of insulin receptor (IR) A and B isoforms, IGF-IR, and IR/IGF-IR hybrid receptors in vascular smooth muscle cells and their role in cell migration in atherosclerosis. Cardiovasc Diabetol. 2016 Dec 1;15(1):161. doi: 10.1186/s12933-016-0477-3.
研究記録日
主要日程の研究
研究開始 (実際)
一次修了 (予想される)
研究の完了 (予想される)
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
その他の研究ID番号
- ER.ALL.2018.39
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?
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
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アンドロゲン受容体異常の臨床試験
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Sun Yat-sen Universityまだ募集していません子宮頸癌 | 化学療法効果 | ネオアジュバント療法 | Programmed Cell Death 1 Receptor / アンタゴニストと阻害剤