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

Completed

• Conditions: Obesity

• Registration Number: NCT05667558
• Lead Sponsor: Medical University of Bialystok

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).

Detailed Description

Not available

Study Timeline

• Study Start: 2017-11-30
• Primary Completion: 2018-12-31
• Study Completion: 2018-12-31
• Status Verified: 2022-11
• Study First Submitted: 2022-12-01
• Study First Submitted QC: 2022-12-19
• Last Update Submitted: 2022-12-19
• Study First Posted: 2022-12-28
• Last Update Posted: 2022-12-28

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 30

Inclusion Criteria

Not provided

Exclusion Criteria

• pregnancy
• gastrointestinal cancers
• cardiorespiratory failure

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
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.
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.
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.
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)
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

Trial Locations

Locations (1)

Medical University of Bialystok; 🇵🇱 Białystok, Poland