Hemodynamic and Functional Characteristics of the Cerebral Circulation in Obesity

NCT06067113 | Unknown

• 1 other identifier: PIC044-23_HRJC
• Study Type: observational
• Target: 40
• Locations: 1 country
• Sites: 1

Brief Summary

This prospective study is intended to explore differences in the cerebral hemodynamics and vascular functional characteristics between obese and normo-constituted patients; as well as the changes in the hemodynamic and functional characteristics in those same obese patients following the intense weight-loss that happens after bariatric surgery.

Conditions

Cerebral Arterial Diseases

Keywords

Brain arteries; Brain hemodynamics; Obesity; Flow velocity; Vasoreactivity

Outcome Measures

Primary Outcomes (1)

• Mean flow velocity in middle cerebral artery

  Mean flow velocity in middle cerebral artery

  through study completion, an average of 1 year

Secondary Outcomes (3)

• Ankle-brachial index

  through study completion, an average of 1 year

• Intima-media thickness in distal CCA

  through study completion, an average of 1 year

• Endothelium-dependent brachial artery vasodilation

  through study completion, an average of 1 year

Study Arms (2)

Obese

Obese patients with an indication for bariatric surgery

Procedure: Supraaortic and transcranial duplex

Controls

Age and sex-matched controls

Procedure: Supraaortic and transcranial duplex

Interventions

Supraaortic and transcranial duplex PROCEDURE

Ecographic evaluation of supraaortic and transcranial arteries, including presence of plaques, flow velocities and pulsatility index

Also known as: Brachial-ankle index, Brachial artery endothelium-dependent vasodilation

Controls; Obese

Eligibility Criteria

• Age: 18 Years - 59 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)
• Sampling Method: Non-Probability Sample

Study Population

Patients between 18 and 59 years with morbid obesity and an indication for bariatric surgery after evaluation by the hospital's interdisciplinary commission, who are included on the surgical waiting list.

You may qualify if:

• Morbid obesity (BMI above 40) or a BMI of 35 and obesity-related health conditions
• Indication for bariatric surgery as losing weight treatment
• Sign informed consent

You may not qualify if:

• Age under 18 years or over 59 years
• Pregnancy
• Patients with acute heart disease
• Denial or withdrawal of the informed consent
• Absence of acoustic window despite the use of eco-enhancers.
• Inability to channel a peripheral line.
• The subject fails to achieve, after surgery, a weight loss of at least 25% of the initial weight

Sponsors & Collaborators

• Instituto de Investigación Sanitaria de la Fundación Jiménez Díaz: lead

Study Sites (1)

Hospital Universitario Rey Juan Carlos

Móstoles, Madrid, 28933, Spain

RECRUITING

Related Publications (8)

• Frosen J, Joutel A. Smooth muscle cells of intracranial vessels: from development to disease. Cardiovasc Res. 2018 Mar 15;114(4):501-512. doi: 10.1093/cvr/cvy002.

  PMID: 29351598 BACKGROUND

• Hubert HB, Feinleib M, McNamara PM, Castelli WP. Obesity as an independent risk factor for cardiovascular disease: a 26-year follow-up of participants in the Framingham Heart Study. Circulation. 1983 May;67(5):968-77. doi: 10.1161/01.cir.67.5.968.

  PMID: 6219830 RESULT

• Fantuzzi G, Mazzone T. Adipose tissue and atherosclerosis: exploring the connection. Arterioscler Thromb Vasc Biol. 2007 May;27(5):996-1003. doi: 10.1161/ATVBAHA.106.131755. Epub 2007 Feb 15.

  PMID: 17303782 RESULT

• Kidwell CS, el-Saden S, Livshits Z, Martin NA, Glenn TC, Saver JL. Transcranial Doppler pulsatility indices as a measure of diffuse small-vessel disease. J Neuroimaging. 2001 Jul;11(3):229-35. doi: 10.1111/j.1552-6569.2001.tb00039.x.

  PMID: 11462287 RESULT

• Ghorbani A, Ahmadi MJ, Shemshaki H. The value of transcranial Doppler derived pulsatility index for diagnosing cerebral small-vessel disease. Adv Biomed Res. 2015 Feb 17;4:54. doi: 10.4103/2277-9175.151574. eCollection 2015.

  PMID: 25802823 RESULT

• Mok V, Ding D, Fu J, Xiong Y, Chu WW, Wang D, Abrigo JM, Yang J, Wong A, Zhao Q, Guo Q, Hong Z, Wong KS. Transcranial Doppler ultrasound for screening cerebral small vessel disease: a community study. Stroke. 2012 Oct;43(10):2791-3. doi: 10.1161/STROKEAHA.112.665711. Epub 2012 Sep 4.

  PMID: 22949475 RESULT

• Foerstl H, Biedert S, Hewer W. Multiinfarct and Alzheimer-type dementia investigated by transcranial Doppler sonography. Biol Psychiatry. 1989 Oct;26(6):590-4. doi: 10.1016/0006-3223(89)90084-x.

  PMID: 2790097 RESULT

• Harris S, Reyhan T, Ramli Y, Prihartono J, Kurniawan M. Middle Cerebral Artery Pulsatility Index as Predictor of Cognitive Impairment in Hypertensive Patients. Front Neurol. 2018 Jul 20;9:538. doi: 10.3389/fneur.2018.00538. eCollection 2018.

  PMID: 30083126 RESULT

Related Links

• WHO \| 10 facts on obesity.

MeSH Terms

Conditions

Cerebral Arterial Diseases; Obesity

Condition Hierarchy (Ancestors)

Intracranial Arterial Diseases; Cerebrovascular Disorders; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Vascular Diseases; Cardiovascular Diseases; Overweight; Overnutrition; Nutrition Disorders; Nutritional and Metabolic Diseases; Body Weight; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Central Study Contacts

Jose Fernandez-Ferro, MD MSc

CONTACT

659136245; jose.fferro@hospitalreyjuancarlos.es

Teresa Montalvo Moraleda, MD

CONTACT

maria.montalvom@quironsalud.es

Study Design

• Study Type: observational
• Observational Model: CASE CONTROL
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: August 18, 2023
• First Posted: October 4, 2023
• Study Start: May 15, 2023
• Primary Completion: February 28, 2024
• Study Completion: February 28, 2024
• Last Updated: October 6, 2023

Record last verified: 2023-06

Data Sharing

• IPD Sharing: Will not share

Locations

ES (1)