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

December 19, 2022 updated by: Medical University of Bialystok

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

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).

Study Overview

Status

Completed

Conditions

Study Type

Observational

Enrollment (Actual)

30

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Poland
      • Białystok, Poland, 15-089
        • Medical University of Bialystok

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 64 years (Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Sampling Method

Non-Probability Sample

Study Population

The study included 30 obese patients (15 women and 15 man) who met the criteria for beaing included in the study and who did not possess excusion criteria.inclusion criteria

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Observational Models: Case-Only
  • Time Perspectives: Prospective

Cohorts and Interventions

Group / Cohort
Study grup

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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.
before and 1,3 and 6 months after LSG
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.
1, 3 and 6 months after LSG
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)
before and 1,3 and 6 months after LSG
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.
before and 1,3 and 6 months after LSG
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
before and 1,3 and 6 months after LSG

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Medical University of Bialystok

Investigators

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

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

November 30, 2017

Primary Completion (Actual)

December 31, 2018

Study Completion (Actual)

December 31, 2018

Study Registration Dates

First Submitted

December 1, 2022

First Submitted That Met QC Criteria

December 19, 2022

First Posted (Actual)

December 28, 2022

Study Record Updates

Last Update Posted (Actual)

December 28, 2022

Last Update Submitted That Met QC Criteria

December 19, 2022

Last Verified

November 1, 2022

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • N/ST/MN/18/001/3316

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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