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

Sponsor
Eastern Mediterranean University (Other)
Overall Status
Completed
CT.gov ID
NCT05690139
Collaborator
(none)
55
1
29
1.9

Study Details

Study Description

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.

Condition or Disease Intervention/Treatment Phase
  • 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 Design

Study Type:
Observational
Actual Enrollment :
55 participants
Observational Model:
Other
Time Perspective:
Prospective
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
Actual Study Start Date :
Jul 6, 2020
Actual Primary Completion Date :
Jul 6, 2021
Actual Study Completion Date :
Dec 6, 2022

Arms and Interventions

Arm 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

Outcome Measures

Primary Outcome Measures

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

  1. Comparing the waist circumference (cm) of all interventions [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 [6 months]

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

  3. Comparing the body fat percentage (%) of all interventions [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 [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 [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 [6 months]

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

Eligibility Criteria

Criteria

Ages Eligible for Study:
18 Years to 65 Years
Sexes Eligible for Study:
All
Accepts Healthy Volunteers:
No
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)

Contacts and Locations

Locations

Site City State Country Postal Code
1 Eastern Mediterranean University Famagusta Cyprus 99450

Sponsors and Collaborators

  • Eastern Mediterranean University

Investigators

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

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.
Responsible Party:
Eastern Mediterranean University
ClinicalTrials.gov Identifier:
NCT05690139
Other Study ID Numbers:
  • ETK00-2020-0168
First Posted:
Jan 19, 2023
Last Update Posted:
Jan 19, 2023
Last Verified:
Jan 1, 2023
Individual Participant Data (IPD) Sharing Statement:
Undecided
Plan to Share IPD:
Undecided
Studies a U.S. FDA-regulated Drug Product:
No
Studies a U.S. FDA-regulated Device Product:
No

Study Results

No Results Posted as of Jan 19, 2023