NCT06368232

Brief Summary

This study aims to evaluate the nutritional status of morbidly obese patients following gastric bypass surgery. Data from 76 patients aged 19-64, who will be monitored by a dietitian for at least six months, will be analyzed. Preoperative and postoperative biochemical parameters along with anthropometric measurements will assess.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
76

participants targeted

Target at P50-P75 for all trials

Timeline
Completed

Started Feb 2022

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

February 15, 2022

Completed
1.2 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

April 15, 2023

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

April 15, 2023

Completed
12 months until next milestone

First Submitted

Initial submission to the registry

March 26, 2024

Completed
21 days until next milestone

First Posted

Study publicly available on registry

April 16, 2024

Completed
Last Updated

April 16, 2024

Status Verified

April 1, 2024

Enrollment Period

1.2 years

First QC Date

March 26, 2024

Last Update Submit

April 11, 2024

Conditions

Keywords

GastrectomyBariatric SurgeryNutritional Status

Outcome Measures

Primary Outcomes (9)

  • Body Weight

    Kilograms (kg)

    Preoperative period, postoperative months 1 and 6

  • BMI (Body Mass Index)

    Kilograms per square meter (kg/m2)

    Preoperative period, postoperative months 1 and 6

  • Lean Mass

    Kilograms (kg)

    Preoperative period, postoperative months 1 and 6

  • Fat Mass

    Kilograms (kg)

    Preoperative period, postoperative months 1 and 6

  • Fasting Blood Glucose

    Milligrams per deciliter (mg/dL)

    Preoperative period, postoperative months 1 and 6

  • HbA1c

    Percentage (%)

    Preoperative period, postoperative months 1 and 6

  • Iron levels

    Micrograms per deciliter (µg/dL)

    Preoperative period, postoperative months 1 and 6

  • Vitamin D level

    Nanograms per milliliter (ng/mL)

    Preoperative period, postoperative months 1 and 6

  • Lipid Profile (Triglycerides, LDL, HDL)

    Milligrams per deciliter (mg/dL)

    Preoperative period, postoperative months 1 and 6

Interventions

Patients will not be intervened. Only nutritional status after bariatric surgery will be evaluated.The data of 76 patients aged 19-64 years who had undergone bariatric surgery and were followed by a dietitian dietitian for at least 6 months were included.

Eligibility Criteria

Age19 Years - 64 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64)
Sampling MethodProbability Sample
Study Population

Data from 76 patients aged 19-64 years who applied to the General Surgery Obesity and Metabolic Surgery clinic and were followed up for six months were included.

You may qualify if:

  • Data of patients aged 19-64 years
  • Data of patients with BMI ≥ 40 kg/m2 or BMI ≥ 35 kg/m2 and at least one comorbidity such as obesity-related hypertension, dyslipidemia, type 2 diabetes mellitus, and sleep apnea
  • Data of patients who underwent sleeve gastrectomy
  • Volunteering

You may not qualify if:

  • Data of patients who were not deemed suitable for surgery by the physician and to whom a surgical technique different from sleeve gastrectomy was applied
  • Data of patients who were not followed up by a dietitian for six months after surgery
  • Data of patients with gastrointestinal inflammatory bowel disease
  • Data of patients with psychiatric disorders diagnosed by a physician
  • Data of patients with cancer, pregnant and lactating women, alcohol or drug addiction

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Ankara Yıldırım Beyazıt University

Ankara, 06760, Turkey (Türkiye)

Location

MeSH Terms

Conditions

Obesity

Condition Hierarchy (Ancestors)

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

Study Officials

  • Yahya Özdoğan, Assoc. Prof

    Ankara Yıldırım Beyazıt Üniversity

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
observational
Observational Model
CASE ONLY
Time Perspective
RETROSPECTIVE
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Assistant Professor

Study Record Dates

First Submitted

March 26, 2024

First Posted

April 16, 2024

Study Start

February 15, 2022

Primary Completion

April 15, 2023

Study Completion

April 15, 2023

Last Updated

April 16, 2024

Record last verified: 2024-04

Data Sharing

IPD Sharing
Will not share

individual participant data (IPD) don't be available to other researchers

Locations