AR, IGF-IR, IR and Peripheral Artery Disease

NCT04710186 | Unknown DMC

• 1 other identifier: ER.ALL.2018.39
• Study Type: observational
• Target: 30
• Locations: 1 country
• Sites: 1

Brief Summary

Peripheral artery Disease (PAD) is a major cardiovascular disease that can impair quality of life (QoL). It affects more often male patients and its pathophysiology is not completely known. Probably androgen receptors and metabolism alteration may play an important role in the onset and in the progression of PAD towards its dreadful complications. The aim of this study is to evaluate the role of Androgen Recetpr , IGF-I receptor, and Insulin Receptor on the arterial wall of male patients with PAD undergoing open revascularization surgery.

Conditions

Androgen Receptor Abnormal; Insulin-Like Growth Factor I Deficiency; Insulin Receptor, Defect in

Keywords

peripheral artery disease; androgen receptor; Insulin-Like Growth Factor I; Insulin Receptor; Male

Outcome Measures

Primary Outcomes (1)

• Expression of AR, IGF-IR, IR

  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

  at 1year

Study Arms (1)

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.

Procedure: arterial reconstructive open surgery

Interventions

arterial reconstructive open surgery PROCEDURE

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.

Male patients with PAD

Eligibility Criteria

• Age: 18 Years+
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Inclusion criteria were patients with age \>18 years, severe peripheral artery disease that needs surgical repair. Patients with life expectancy \<6 months, advanced liver or heart disease and active malignancies were excluded. At the moment of hospital admission, clinicians collected the medical history including previous cardiovascular disease (CVD: stroke, coronary heart disease, heart failure, peripheral vascular disease), presence of dysmetabolism, history of arterial hypertension and diabetes, previous amputation, history of chronic kidney disease (CKD). Therapies practiced at home, encompassing hypoglycemic oral agents, insulin, blood pressure lowering drugs, statins, antiplatelet and anticoagulants were also collected.

You may qualify if:

• Male patients with peripheral artery disease (PAD) eligible to receive arterial reconstructive open surgery.

You may not qualify if:

• active malignancy
• advanced liver disease
• advanced heart disease

Sponsors & Collaborators

• University of Catanzaro: lead

Study Sites (1)

University Magna Graecia of Catanzaro

Catanzaro, 88100, Italy

RECRUITING

Related Publications (6)

• 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.

  PMID: 31303293 BACKGROUND

• 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.

  PMID: 32479881 BACKGROUND

• 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.

  PMID: 14707008 BACKGROUND

• 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.

  PMID: 30410343 BACKGROUND

• 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.

  PMID: 30194317 BACKGROUND

• 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.

  PMID: 27905925 BACKGROUND

MeSH Terms

Conditions

Insulin-Like Growth Factor I Deficiency; Insulin Receptor, Defect in; Peripheral Arterial Disease; Bulbo-Spinal Atrophy, X-Linked

Condition Hierarchy (Ancestors)

Atherosclerosis; Arteriosclerosis; Arterial Occlusive Diseases; Vascular Diseases; Cardiovascular Diseases; Peripheral Vascular Diseases; Muscular Atrophy, Spinal; Spinal Cord Diseases; Central Nervous System Diseases; Nervous System Diseases; Heredodegenerative Disorders, Nervous System; Neurodegenerative Diseases; Motor Neuron Disease; Neuromuscular Diseases; Genetic Diseases, X-Linked; Genetic Diseases, Inborn; Congenital, Hereditary, and Neonatal Diseases and Abnormalities

Study Officials

• Raffaele Serra, M.D., Ph.D.

  University Magna Graecia of Catanzaro

  PRINCIPAL INVESTIGATOR

• Marcello Maggiolini, M.D.

  UNICAL - University of Calabria

  STUDY CHAIR

Central Study Contacts

Raffaele Serra, M.D., Ph.D.

CONTACT

+3909613647380; rserra@unicz.it

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Associate Professor of Vascular Surgery

Study Record Dates

• First Submitted: January 11, 2021
• First Posted: January 14, 2021
• Study Start: August 1, 2018
• Primary Completion: February 1, 2021
• Study Completion: March 1, 2021
• Last Updated: January 14, 2021

Record last verified: 2021-01

Data Sharing

• IPD Sharing: Will not share

Locations

IT (1)