Sleeve-gastrectomy Efficacy in Morbid Obese Patient With a Focus on the Role of Inflammation

Morbid Obesity Clinical Trial

Official title:

Sleeve-gastrectomy Efficacy in the Treatment of Metabolic and Vascular Dysfunction of Morbid Obese Patient With a Focus on the Role of Inflammation

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT03559842
• Other study ID #: 2017-15
• Status: Recruiting
• Start date: May 4, 2017
• Est. completion date: December 31, 2022

Study information

• Verified date: March 2020
• Source: University Of Perugia
• Contact: Graziana Lupattelli, Prof
• Phone: 00390755784023
• Email: graziana.lupattelli[@]unipg.it
• Is FDA regulated: No
• Study type: Observational

Clinical Trial Summary

Despite the wide range of studies concerning the positive effects of bariatric surgery on metabolic state of morbid obese patient, it is necessary to further investigate the specific role of the "sleeve-gastrectomy" intervention, going not only to research results in terms of safety or efficacy on the treatment of comorbidities, but also aimed to understand whether the improvement of metabolic and cardiovascular parameters is due to total weight loss or rather to visceral fat loss, and how much of this improvement is attributable to changes in inflammatory status. The primary endpoint of the study is to evaluate the effect of sleeve-gastrectomy on metabolic parameters (glyco-lipidic assessment, vitamins), bone-remodelling parameters (vitamin D, parathormone) and cardiovascular parameters (blood pressure, flow-mediated dilation, indexed left ventricular mass, inter-ventricular septum, carotid intima-media thickness) in a large obese population on the basis of total weight loss (TWL), variation of visceral fat area (VFA), variation of peri-renal fat thickness and insulin resistance index ("Homeostasis Model Assessment-insulin resistance" - HOMA). In addition the investigators set themselves the objective of assessing whether the presence of comorbidities (diabetes and hypertension) can influence the effects of the intervention on the above parameters, and whether the levels of the NETs and of adipokines such as chemerin in the pre- and post-intervention can correlate with the metabolic-vascular dysfunction, and play a role in its eventual improvement.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 400
• Est. completion date: December 31, 2022
• Est. primary completion date: December 31, 2022
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years to 65 Years

Eligibility

Inclusion Criteria:

• BMI = 40 kg / m2 (or = 35 kg / m2 with at least one comorbidity), aged between 18 and 65 years.

Exclusion Criteria:

• renal or hepatic impairment

• heart failure (New York Heart Association - NYHA II-IV)

• secondary causes of obesity

• major psychiatric disorders

Related Conditions & MeSH terms

• Inflammation
• Morbid Obesity
• Obesity, Morbid

Locations

Country	Name	City	State
Italy	Internal Medicine	Perugia

Sponsors (1)

Lead Sponsor	Collaborator
University Of Perugia

Country where clinical trial is conducted

Italy, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	flow-mediated dilation	ultrasound evaluation	One year
Primary	obesity-related cardiomyopathy	cardiac ultrasonography	One year
Primary	insulin resistance	HOMA index	One year
Primary	ectopic adiposity	ultrasound evaluation of visceral fat	One year
Primary	inflammation	high sensitivity C reactive protein, sclerostin, osteopontin, cathepsin K, IL-10	One year
Primary	blood pressure	systolic and diastolic blood pressure	One year
Primary	carotid intima-media thickness	ultrasound evaluation	One year
Primary	microcirculatory function	Laser-Doppler flowmetry	One year
Primary	aortic stiffness	tonometry	One year
Primary	cardiovascular assessment	anti-hypertensive therapy variation (number of drugs)	One year
Primary	dyslipidemia	total cholesterol, triglycerides, HDL, LDL	One year
Primary	liver function	Evaluation of "Non-alcoholic fatty liver disease" (NAFLD) fibrosis score according to the following formula: -1.675 + 0.037 × age (years) + 0.094 × BMI (kg/m2) + 1.13 × IFG/diabetes (yes = 1, no = 0) + 0.99 × AST/ALT ratio - 0.013 × platelet (×109/l) - 0.66 × albumin (g/dl).; Cutoffs: NAFLD Score < -1.455 = low grade fibrosis; NAFLD Score -1.455 - 0.675 = indeterminate score; NAFLD Score > 0.675 = high grade fibrosis.	One year
Primary	biliary acid and sterols assessment	laboratory analysis	One year
Primary	bone metabolism assessment	vitamin D, PTH	One year
Primary	nutritional assessment	sideremia, vitamin B12, folates	One year
Primary	adipose tissue quantification	bioimpedentiometry	One year
Primary	adipokines	chemerin, leptin and adiponectin plasmatic dosage	One year
Primary	NETs	"Neutrophil extracellular traps" dosage	One year
Secondary	inflammatory bone remodeling markers	sclerostin, osteopontin, cathepsin K	One year
Secondary	macrophages commitment markers	interleukin-10	One year