Assessment of the Clinical Condition and Way of Nutrition Patients Before and After Sleeve Gastrectomy

Sponsor
Medical University of Bialystok (Other)
Overall Status
Completed
CT.gov ID
NCT05667558
Collaborator
(none)
30
1
13
2.3

Study Details

Study Description

Brief Summary

Conservative treatment of patients with morbid obesity is inefficient, which is why surgical treatment is necessary. Although bariatric treatment is associated with the occurrence of complications resulting from the procedure or from nutritional insufficiencies, it leads to significant body mass reduction and metabolic improvement of obese patients.

The aim of the study was to determine the clinical condition of obese patients after laparoscopic sleeve gastrectomy ( LSG) in terms of nutritional status, metabolic disorders and way of nutrition.

The study conduced 4 visits: preliminary visit (1 day before the surgery) and control visits (1, 3 and 6 months after the surgery). Based on the inclusion and exclusion criteria the observational study was conducted among 30 participants (15 women and 15 men).

Condition or Disease Intervention/Treatment Phase

    Study Design

    Study Type:
    Observational
    Actual Enrollment :
    30 participants
    Observational Model:
    Case-Only
    Time Perspective:
    Prospective
    Official Title:
    Assessment of Intake of Energy and Selected Nutrients, Nutritional Status, Body Composition and Biochemical Parameters of Obese Patients Before and After Bariatric Surgery
    Actual Study Start Date :
    Nov 30, 2017
    Actual Primary Completion Date :
    Dec 31, 2018
    Actual Study Completion Date :
    Dec 31, 2018

    Arms and Interventions

    Arm Intervention/Treatment
    Study grup

    Outcome Measures

    Primary Outcome Measures

    1. Changes in anthropometric measurements during the 6 months after surgery [before and 1,3 and 6 months after LSG]

      Body weight in kilograms was measured using a scale with stadiometer. Body height in meters was measured using a scale with stadiometer. Body weight and height were used to calculate BMI (Body Mass Index) in kilograms divided by square metres. Hip circumference in centimeters was measured at the greater trochanters at the widest part of the hips. Waist circumference in centimeters was measured at the uppermost lateral border of the hip crest.

    2. Changes in percentage of excess weight loss during the 6 months after surgery [1, 3 and 6 months after LSG]

      Percentage of excess weight loss (%EWL) was calculated using the formula: %EWL = (preoperative weight - current weight)/(preoperative weight - ideal weight) × 100. Ideal body weight was calculated using Lorentz formula.

    3. Changes in body composition during the 6 months after surgery [before and 1,3 and 6 months after LSG]

      Body composition was assessed four times (before and 1,3 and 6 months after LSG). Body composition parameters (fat mass in kilograms, percentage of body fat, fat free mass in kilograms, percentage of fat free mass, total body water in liters, percentage of total body water) was determined using the bioelectrical impedance method (BioScan 920-2 body composition analyzer, Maltron International Ltd., United Kingdom)

    4. Changes in energy and selected nutrients intake during the 6 months after surgery [before and 1,3 and 6 months after LSG]

      The intake of energy and selected nutrients was assessed four times (before and 1,3 and 6 months after LSG). A 3-day nutrition interview was collected. The supply of energy, protein, fat (including fatty acids), carbohydrates, dietary fibre, vitamins and minerals in the usual diet was assessed.

    5. Changes in blood biochemical parameters of patients during the 6 months after surgery. [before and 1,3 and 6 months after LSG]

      The biochemical parameters of the patient's blood were assessed four times (before and 1,3 and 6 months after LSG). Laboratory tests were performer to determine the following serum levels: fasting glucose, fasting insulin,total cholesterol, LDL cholesterol fraction, HDL cholesterol fraction, triglycerides and aminotransferases: alanine (ALT) and aspartate (AST), complete blood count. The HOMA-IR (homeostasis model assessment of insulin resistance) index was calculated according to the formula: [fasting insulin (mIU/l) x fasting glucose (mg/dl)] / 405

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    18 Years to 64 Years
    Sexes Eligible for Study:
    All
    Accepts Healthy Volunteers:
    No

    Inclusion criteria

    • women and men aged 18-64

    • BMI ≥ 40 kg/m2 or BMI ≥ 35 kg/m2 with comorbidities such as type II diabetes (T2DM), hypertension, sleep apnea and other respiratory disorders, non-alcoholic fatty liver disease, osteoarthritis, lipid abnormalities, gastrointestinal disorders, or heart disease

    Exclusion Criteria:
    • pregnancy

    • gastrointestinal cancers

    • cardiorespiratory failure

    Contacts and Locations

    Locations

    Site City State Country Postal Code
    1 Medical University of Bialystok Białystok Poland 15-089

    Sponsors and Collaborators

    • Medical University of Bialystok

    Investigators

    • Study Director: Lucyna Ostrowska, Professor, Department of Dietetics and Clinical Nutrition Medical University of Bialystok

    Study Documents (Full-Text)

    None provided.

    More Information

    Publications

    Responsible Party:
    Medical University of Bialystok
    ClinicalTrials.gov Identifier:
    NCT05667558
    Other Study ID Numbers:
    • N/ST/MN/18/001/3316
    First Posted:
    Dec 28, 2022
    Last Update Posted:
    Dec 28, 2022
    Last Verified:
    Nov 1, 2022
    Studies a U.S. FDA-regulated Drug Product:
    No
    Studies a U.S. FDA-regulated Device Product:
    No
    Keywords provided by Medical University of Bialystok
    Additional relevant MeSH terms:

    Study Results

    No Results Posted as of Dec 28, 2022