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

Study Overview
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Brief Summary
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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.

Detailed Description
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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.

Official Title
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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

Conditions
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Obesity, Bariatric Surgery Candidate, Healthy Eating Index

Intervention / Treatment
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* Procedure: Pre-operative LSG patients
* Procedure: Post-operative patients 1st month
* Procedure: Post-operative patients 3rd month
* Procedure: Post-operative patients 6th month


Participation Criteria
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Eligibility Criteria
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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)

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 65 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Obese patients<br>Obese patients received LSG surgery approval | Procedure: Pre-operative LSG patients<br>* Baseline<br>Procedure: Post-operative patients 1st month<br>* 1 month after surgery<br>Procedure: Post-operative patients 3rd month<br>* 3 months after surgery<br>Procedure: Post-operative patients 6th month<br>* 6 months after surgery<br>|

What is the study measuring?
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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 |