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

NCT03559842 | Unknown

• 1 other identifier: 2017-15
• Study Type: observational
• Target: 400
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Morbid Obesity

Outcome Measures

Primary Outcomes (18)

• flow-mediated dilation

  ultrasound evaluation

  One year

• obesity-related cardiomyopathy

  cardiac ultrasonography

  One year

• insulin resistance

  HOMA index

  One year

• ectopic adiposity

  ultrasound evaluation of visceral fat

  One year

• inflammation

  high sensitivity C reactive protein, sclerostin, osteopontin, cathepsin K, IL-10

  One year

• blood pressure

  systolic and diastolic blood pressure

  One year

• carotid intima-media thickness

  ultrasound evaluation

  One year

• microcirculatory function

  Laser-Doppler flowmetry

  One year

• aortic stiffness

  tonometry

  One year

• cardiovascular assessment

  anti-hypertensive therapy variation (number of drugs)

  One year

• dyslipidemia

  total cholesterol, triglycerides, HDL, LDL

  One year

• 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

• biliary acid and sterols assessment

  laboratory analysis

  One year

• bone metabolism assessment

  vitamin D, PTH

  One year

• nutritional assessment

  sideremia, vitamin B12, folates

  One year

• adipose tissue quantification

  bioimpedentiometry

  One year

• adipokines

  chemerin, leptin and adiponectin plasmatic dosage

  One year

• NETs

  "Neutrophil extracellular traps" dosage

  One year

Secondary Outcomes (2)

• inflammatory bone remodeling markers

  One year

• macrophages commitment markers

  One year

Study Arms (2)

Surgery patients

Obese patients undergoing laparoscopic sleeve gastrectomy

Non-surgery patients

Obese patients not undergoing laparoscopic sleeve gastrectomy (delayed or refused proposed treatment)

Eligibility Criteria

• Age: 18 Years - 65 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Probability Sample

Study Population

Morbid obese patients with BMI ≥ 40 kg / m2 (or ≥ 35 kg / m2 with at least one comorbidity)

You may qualify if:

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

You may not qualify if:

• renal or hepatic impairment
• heart failure (New York Heart Association - NYHA II-IV)
• secondary causes of obesity
• major psychiatric disorders

Sponsors & Collaborators

• University Of Perugia: lead

Study Sites (1)

Internal Medicine

Perugia, 06132, Italy

RECRUITING

Biospecimen

Retention: SAMPLES WITHOUT DNA

whole blood, serum, plasma

MeSH Terms

Conditions

Obesity, Morbid

Condition Hierarchy (Ancestors)

Obesity; Overweight; Overnutrition; Nutrition Disorders; Nutritional and Metabolic Diseases; Body Weight; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Central Study Contacts

Graziana Lupattelli, Prof

CONTACT

00390755784023; graziana.lupattelli@unipg.it

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Study Record Dates

• First Submitted: May 19, 2018
• First Posted: June 18, 2018
• Study Start: May 4, 2017
• Primary Completion: December 31, 2022
• Study Completion: December 31, 2022
• Last Updated: March 11, 2020

Record last verified: 2020-03

Locations

IT (1)