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

Obesity Clinical Trial

Official 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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT05690139
• Other study ID #: ETK00-2020-0168
• Status: Completed
• Start date: July 6, 2020
• Est. completion date: December 6, 2022

Study information

• Verified date: January 2023
• Source: Eastern Mediterranean University
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial Summary

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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 55
• Est. completion date: December 6, 2022
• Est. primary completion date: July 6, 2021
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 65 Years

Eligibility

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)

Related Conditions & MeSH terms

• Bariatric Surgery Candidate
• Obesity

Intervention

Procedure:
• Pre-operative LSG patients
Baseline
• Post-operative patients 1st month
1 month after surgery
• Post-operative patients 3rd month
3 months after surgery
• Post-operative patients 6th month
6 months after surgery

Locations

Country	Name	City	State
Cyprus	Eastern Mediterranean University	Famagusta

Sponsors (1)

Lead Sponsor	Collaborator
Eastern Mediterranean University

Country where clinical trial is conducted

Cyprus, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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
Primary	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
Primary	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	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
Secondary	Comparing the body mass index (BMI) of all interventions	BMI was calculated (weight/height squared; in kilograms per square meter)	6 months
Secondary	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
Secondary	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
Secondary	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
Secondary	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