Clinical trial NCT05690139: Evaluation of Bariatric Surgery Patients Before and After Sleeve Gastrectomy in Terms of Nutritional Status
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
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Obesity
Bariatric Surgery Candidate
Healthy Eating Index
Lead sponsor: Eastern Mediterranean University
Sponsor class: OTHER
First posted: 2023-01-19
Enrollment: 55
Sex: ALL
Minimum age (years): 18
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: OTHER
Time perspective: PROSPECTIVE
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).

Brief 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.

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.

Eligibility criteria: 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)

Primary outcomes:
measure: Comparing the 3-day food diaries (1 weekend day and 2 weekdays) taken during each intervention (pre-post operative 1,3,6 months)
timeFrame: 6 months
measure: Three Factor Eating Questionnaire Revised-21 (TFEQ-Tr21) scale
timeFrame: 6 months
measure: Healthy Eating Index (HEI-2010)
timeFrame: 6 months
Secondary outcomes:
measure: Comparing the waist circumference (cm) of all interventions
timeFrame: 6 months
measure: Comparing the body mass index (BMI) of all interventions
timeFrame: 6 months
measure: Comparing the body fat percentage (%) of all interventions
timeFrame: 6 months
measure: Comparing the fasting blood glucose levels of all interventions
timeFrame: 6 months
measure: Comparing the serum lipid levels of all interventions
timeFrame: 6 months
measure: Comparing the serum B12 levels of all interventions
timeFrame: 6 months
Other outcomes:
Locations:
city: Famagusta
country: Cyprus
facility: Eastern Mediterranean University
Study officials:
affiliation: Eastern Mediterranean University
name: Sema Erge, Asst. Prof.
role: STUDY_CHAIR
References: