NCT05690139

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
55

participants targeted

Target at P25-P50 for all trials

Timeline
Completed

Started Jul 2020

Typical duration for all trials

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

July 6, 2020

Completed
1 year until next milestone

Primary Completion

Last participant's last visit for primary outcome

July 6, 2021

Completed
1.4 years until next milestone

Study Completion

Last participant's last visit for all outcomes

December 6, 2022

Completed
1 month until next milestone

First Submitted

Initial submission to the registry

January 10, 2023

Completed
9 days until next milestone

First Posted

Study publicly available on registry

January 19, 2023

Completed
Last Updated

January 19, 2023

Status Verified

January 1, 2023

Enrollment Period

1 year

First QC Date

January 10, 2023

Last Update Submit

January 10, 2023

Conditions

ObesityBariatric Surgery CandidateHealthy Eating Index

Outcome Measures

Primary Outcomes (3)

  • 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 Outcomes (6)

  • Comparing the waist circumference (cm) of all interventions

    6 months

  • Comparing the body mass index (BMI) of all interventions

    6 months

  • Comparing the body fat percentage (%) of all interventions

    6 months

  • Comparing the fasting blood glucose levels of all interventions

    6 months

  • Comparing the serum lipid levels of all interventions

    6 months

  • +1 more secondary outcomes

Study Arms (1)

Obese patients

Obese patients received LSG surgery approval

Procedure: Pre-operative LSG patientsProcedure: Post-operative patients 1st monthProcedure: Post-operative patients 3rd monthProcedure: Post-operative patients 6th month

Interventions

Pre-operative LSG patientsPROCEDURE

Baseline

Obese patients
Post-operative patients 1st monthPROCEDURE

1 month after surgery

Obese patients
Post-operative patients 3rd monthPROCEDURE

3 months after surgery

Obese patients
Post-operative patients 6th monthPROCEDURE

6 months after surgery

Obese patients

Eligibility Criteria

Age18 Years - 65 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-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).

You may qualify if:

  • 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

You may not qualify if:

  • Ages \<18 or \>65 years old
  • Having a pacemaker (implantation) or any prosthesis (inconvenient for segmental body analysis)

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Eastern Mediterranean University

Famagusta, 99450, Cyprus

Location

MeSH Terms

Conditions

Obesity

Condition Hierarchy (Ancestors)

OverweightOvernutritionNutrition DisordersNutritional and Metabolic DiseasesBody WeightSigns and SymptomsPathological Conditions, Signs and Symptoms

Study Officials

  • Sema Erge, Asst. Prof.

    Eastern Mediterranean University

    STUDY CHAIR

Study Design

Study Type
observational
Observational Model
OTHER
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

January 10, 2023

First Posted

January 19, 2023

Study Start

July 6, 2020

Primary Completion

July 6, 2021

Study Completion

December 6, 2022

Last Updated

January 19, 2023

Record last verified: 2023-01

Locations

CY(1)