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Completed

NCT Number: NCT05667558

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

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).

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Key information

Conditions

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

Age range

18 year–64 year

Sex eligibility

All sexes

Study type

Observational

Primary location

Medical University of Bialystok

Bialystok, 15-089, Poland

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Primary outcomes

  1. Changes in anthropometric measurements during the 6 months after surgery

    Time frame: 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

    Time frame: 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

    Time frame: 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

    Time frame: 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.

    Time frame: 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

Sponsors and collaborators

Lead sponsor

Medical University of Bialystok

Other

Registry information

Official study title

Assessment of Intake of Energy and Selected Nutrients, Nutritional Status, Body Composition and Biochemical Parameters of Obese Patients Before and After Bariatric Surgery

Important dates

Study start
2017
Primary completion
2018
Study completion
2018
First posted
Dec 28, 2022
Registry last updated
Dec 28, 2022

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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