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Trial record 72 of 123 for:    hypertension "vitamin d"

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

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ClinicalTrials.gov Identifier: NCT03559842
Recruitment Status : Recruiting
First Posted : June 18, 2018
Last Update Posted : June 21, 2018
Sponsor:
Information provided by (Responsible Party):
Maria Anastasia Ricci, University Of Perugia

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.

Condition or disease
Morbid Obesity

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Study Type : Observational
Estimated Enrollment : 200 participants
Observational Model: Case-Only
Time Perspective: Prospective
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
Actual Study Start Date : May 4, 2017
Actual Primary Completion Date : May 19, 2018
Estimated Study Completion Date : May 4, 2020

Group/Cohort
Obese patients
Lean patients



Primary Outcome Measures :
  1. flow-mediated dilation [ Time Frame: One year ]
    ultrasound evaluation

  2. obesity-related cardiomyopathy [ Time Frame: One year ]
    cardiac ultrasonography

  3. insulin resistance [ Time Frame: One year ]
    HOMA index

  4. ectopic adiposity [ Time Frame: One year ]
    ultrasound evaluation of visceral fat

  5. inflammation [ Time Frame: One year ]
    laboratory evaluation of flogosis indexes (CRP)

  6. cardiovascular assessment [ Time Frame: One year ]
    systolic and diastolic blood pressure

  7. carotid intima-media thickness [ Time Frame: One year ]
    ultrasound evaluation

  8. microcirculatory function [ Time Frame: One year ]
    Laser-Doppler flowmetry

  9. aortic stiffness [ Time Frame: One year ]
    tonometry

  10. cardiovascular assessment [ Time Frame: One year ]
    anti-hypertensive therapy variation (number of drugs)

  11. dyslipidemia [ Time Frame: One year ]
    total cholesterol, triglycerides, HDL, LDL

  12. liver function [ Time Frame: One year ]

    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.


  13. biliary acid and sterols assessment [ Time Frame: One year ]
    laboratory analysis

  14. bone metabolism assessment [ Time Frame: One year ]
    vitamin D, PTH

  15. nutritional assessment [ Time Frame: One year ]
    sideremia, vitamin B12, folates

  16. adipose tissue quantification [ Time Frame: One year ]
    bioimpedenziometry

  17. adipokines [ Time Frame: One year ]
    chemerin plasmatic dosage

  18. NETs [ Time Frame: One year ]
    "Neutrophil extracellular traps" dosage


Biospecimen Retention:   Samples Without DNA
whole blood, serum, plasma


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Ages Eligible for Study:   18 Years to 65 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Sampling Method:   Probability Sample
Study Population
Morbid obese patients with BMI ≥ 40 kg / m2 (or ≥ 35 kg / m2 with at least one comorbidity)
Criteria

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03559842


Contacts
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Contact: Graziana Lupattelli, Prof 00390755784023 graziana.lupattelli@unipg.it

Locations
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Italy
Internal Medicine Recruiting
Perugia, Italy, 06132
Contact: Graziana Lupattelli, Prof    00390755784023    graziana.lupattelli@unipg.it   
Sponsors and Collaborators
University Of Perugia

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Responsible Party: Maria Anastasia Ricci, Principal Investigator, University Of Perugia
ClinicalTrials.gov Identifier: NCT03559842     History of Changes
Other Study ID Numbers: 2017-15
First Posted: June 18, 2018    Key Record Dates
Last Update Posted: June 21, 2018
Last Verified: June 2018

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No

Additional relevant MeSH terms:
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Inflammation
Obesity, Morbid
Pathologic Processes
Obesity
Overnutrition
Nutrition Disorders
Overweight
Body Weight
Signs and Symptoms