Skip to main content
OpenTrials
Completed

NCT Number: NCT05690139

Evaluation of Bariatric Surgery Patients Before and After Sleeve Gastrectomy in Terms of Nutritional Status

Background/purpose: Laparoscopic sleeve gastrectomy (LSG) has been defined as an innovative surgical method for the treatment of obesity and is progressively applied worldwide. However, data on result of sleeve gastrectomy regarding energy-protein status, nutrient deficiencies and body composition are limited. The purpose of this study is to search nutritional status, body composition and biochemical parameters following LSG.

Methods: Obese subjects (N:55) scheduled for sleeve gastrectomy were included. Macro-micronutrient intake analysis, biochemical blood parameters, and anthropometric measures were performed before and 1, 3 and 6 months after LSG.

Completed

Looking for future studies?

Notify Me

Key information

Conditions

Obesity Bariatric Surgery Candidate Body Weight Healthy Eating Index Nutrition Disorders Nutritional and Metabolic Diseases Overnutrition Overweight Pathological Conditions, Signs and Symptoms Signs and Symptoms

Age range

18 year–65 year

Sex eligibility

All sexes

Study type

Observational

Primary location

Eastern Mediterranean University

Famagusta, 99450, Cyprus

About this study

Background/purpose: Laparoscopic sleeve gastrectomy (LSG) has been defined as an innovative surgical method for the treatment of obesity and is progressively applied worldwide. Nutritional deficiencies are identified as the possible complications of bariatric surgery. However, data on result of sleeve gastrectomy regarding energy-protein status, nutrient deficiencies and body composition are limited. The purpose of this study is to search nutritional status, body composition and biochemical parameters following LSG.

Methods: Obese subjects (N:55) scheduled for sleeve gastrectomy were included in this study. Preoperative and postoperative (1, 3 and 6th months) protein-energy and other nutrient consumptions, eating habits, food consumption diversity were evaluated with food frequency questionnaire, 3-days food diary record, three-factor eating scale and healthy eating index. Also in the pre- and postoperative period; anthropometric (weight, height, waist, hip, fat free mass) values measured and biochemical blood parameters were collected.

Who can participate

Healthy volunteers accepted: No

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

Inclusion criteria

  • Volunteering to participate in the research,
  • To have sleeve gastrectomy surgery,
  • To be over 18 and under 65 years old
  • Not having a perception disorder and communication problems

Exclusion criteria

  • Ages <18 or >65 years old
  • Having a pacemaker (implantation) or any prosthesis (inconvenient for segmental body analysis)

Treatment and study plan

Pre-operative LSG patients

Procedure

Baseline

Post-operative patients 1st month

Procedure

1 month after surgery

Post-operative patients 3rd month

Procedure

3 months after surgery

Post-operative patients 6th month

Procedure

6 months after surgery

Primary outcomes

  1. Comparing the 3-day food diaries (1 weekend day and 2 weekdays) taken during each intervention (pre-post operative 1,3,6 months)

    Time frame: 6 months

    Daily nutrient intake was calculated by using computer software (Stuttgart, Germany; Turkish version: BeBiS, Vers. 9)

  2. Three Factor Eating Questionnaire Revised-21 (TFEQ-Tr21) scale

    Time frame: 6 months

    Dietary Behavior: A modification of the Three Factor Eating Questionnaire (TFEQ-TR21) was used to assess cognitive restraint of eating, disinhibition, and hunger.

  3. Healthy Eating Index (HEI-2010)

    Time frame: 6 months

    Diet Quality: was assessed using the HEI-2010, a measure of diet quality that assesses how well dietary intake aligns with key recommendations.

Secondary outcomes

  1. Comparing the waist circumference (cm) of all interventions

    Time frame: 6 months

    after the pre and post operative intervention waist circumferences (midway between the rib cage and the iliac crest) were measured using a flexible tape.

  2. Comparing the body mass index (BMI) of all interventions

    Time frame: 6 months

    BMI was calculated (weight/height squared; in kilograms per square meter)

  3. Comparing the body fat percentage (%) of all interventions

    Time frame: 6 months

    the percentage of body fat and fat free mass (FFM) was measured by Tanita Segmental Body Composition Analyzer MC-780MA-N.

  4. Comparing the fasting blood glucose levels of all interventions

    Time frame: 6 months

    Concentration of fasting blood glucose levels baseline and changes after 1,3 and 6 months after surgery were compared. Blood samples were obtained from medical files before surgery and after 1,3,6 months of surgery period, and sera were stored at -30∘ C, until analytical measurements were performed.

  5. Comparing the serum lipid levels of all interventions

    Time frame: 6 months

    Differences in concentration of serum lipid levels of participants in baseline period and after post-operation were measured.

    Blood samples were obtained from medical files at baseline period (pre-operation) and after each intervention period (post-operation 1.3.6 months), and sera were stored at -30∘ C, until analytical measurements were performed. The levels of serum lipids: Triglycerides (mg/dL), Total cholesterol (mg/dL), and HDL cholesterol (mg/dL) were determined using a Dimension Xpand Plus integrated clinical chemistry autoanalyzer (Siemens Healthcare Diagnostics, USA).

  6. Comparing the serum B12 levels of all interventions

    Time frame: 6 months

    baseline, 1,3,6, months after surgery B12 blood measurements taken from patients medical files.

Sponsors and collaborators

Lead sponsor

Eastern Mediterranean University

Other

Registry information

Official study title

Evaluation of Bariatric Surgery Patients Before and After Sleeve Gastrectomy in Terms of Protein-energy and Food Groups Consumption by Three Factors Eating Scale and Healthy Eating Index

Important dates

Study start
2020
Primary completion
2021
Study completion
2022
First posted
Jan 19, 2023
Registry last updated
Jan 19, 2023

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.

Related clinical trials

Published trials that share one or more normalized conditions with this study.