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

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

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.

Study Overview

• Status: Completed
• Conditions: Obesity; Bariatric Surgery Candidate; Healthy Eating Index
• Intervention / Treatment: Procedure: Pre-operative LSG patients; Procedure: Post-operative patients 1st month; Procedure: Post-operative patients 3rd month; Procedure: Post-operative patients 6th month

Detailed Description

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.

• Study Type: Observational
• Enrollment (Actual): 55

Contacts and Locations

Study Locations

• Cyprus
  • Famagusta, Cyprus, 99450
    • Eastern Mediterranean University

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 65 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

• Sampling Method: Non-Probability Sample

Study Population

The population of the study consists of patients who received LSG surgery approval which was conducted in a special obesity clinic, Obezite Cerrahi Ankara Merkezi in Ankara, Turkey.

The decision for surgery was taken after a multidisciplinary meeting, following recommendations of international consensus conferences or expert panels American Society for Metabolic and Bariatric Surgery (ASMBS).

Description

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)

Study Plan

How is the study designed?

Design Details

• Observational Models: Other
• Time Perspectives: Prospective

Number of groups / cohorts

1

Cohorts and Interventions

Group / Cohort	Intervention / Treatment
Obese patients; Obese patients received LSG surgery approval	Procedure: Pre-operative LSG patients; Baseline; Procedure: Post-operative patients 1st month; 1 month after surgery; Procedure: Post-operative patients 3rd month; 3 months after surgery; Procedure: Post-operative patients 6th month; 6 months after surgery

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Comparing the 3-day food diaries (1 weekend day and 2 weekdays) taken during each intervention (pre-post operative 1,3,6 months)	Daily nutrient intake was calculated by using computer software (Stuttgart, Germany; Turkish version: BeBiS, Vers. 9)	6 months
Three Factor Eating Questionnaire Revised-21 (TFEQ-Tr21) scale	Dietary Behavior: A modification of the Three Factor Eating Questionnaire (TFEQ-TR21) was used to assess cognitive restraint of eating, disinhibition, and hunger.	6 months
Healthy Eating Index (HEI-2010)	Diet Quality: was assessed using the HEI-2010, a measure of diet quality that assesses how well dietary intake aligns with key recommendations.	6 months

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Comparing the waist circumference (cm) of all interventions	after the pre and post operative intervention waist circumferences (midway between the rib cage and the iliac crest) were measured using a flexible tape.	6 months
Comparing the body mass index (BMI) of all interventions	BMI was calculated (weight/height squared; in kilograms per square meter)	6 months
Comparing the body fat percentage (%) of all interventions	the percentage of body fat and fat free mass (FFM) was measured by Tanita Segmental Body Composition Analyzer MC-780MA-N.	6 months
Comparing the fasting blood glucose levels of all interventions	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.	6 months
Comparing the serum lipid levels of all interventions	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 months
Comparing the serum B12 levels of all interventions	baseline, 1,3,6, months after surgery B12 blood measurements taken from patients medical files.	6 months

Collaborators and Investigators

• Sponsor: Eastern Mediterranean University
• Investigators: Study Chair: Sema Erge, Asst. Prof., Eastern Mediterranean University

Study record dates

Study Major Dates

• Study Start (Actual): July 6, 2020
• Primary Completion (Actual): July 6, 2021
• Study Completion (Actual): December 6, 2022

Study Registration Dates

• First Submitted: January 10, 2023
• First Submitted That Met QC Criteria: January 10, 2023
• First Posted (Estimate): January 19, 2023

Study Record Updates

• Last Update Posted (Estimate): January 19, 2023
• Last Update Submitted That Met QC Criteria: January 10, 2023
• Last Verified: January 1, 2023

More Information

Terms related to this study

• Other Study ID Numbers: ETK00-2020-0168

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: Undecided

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No