Nutritional Status After Sleeve Gastrectomy in Morbid Obesity: 6-Month Study

Obesity Clinical Trial

Official title:

Evaluation Of Nutritional Status Of Morbid Obesity Patients In The First Six Months After Sleeve Gastrectomy

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT06368232
• Other study ID #: 19.036.123.125
• Status: Completed
• Start date: February 15, 2022
• Est. completion date: April 15, 2023

Study information

• Verified date: April 2024
• Source: Ankara Yildirim Beyazit University
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

Description:

Objective: This retrospective study aims to evaluate the nutritional status of morbidly obese patients in the first six months following sleeve gastrectomy. Methods: The study is planned as a retrospective analysis. The data of 76 patients aged 19-64 years who underwent bariatric surgery and were monitored by a dietitian for at least six months will be included in the study. Preoperative and postoperative biochemical parameters and anthropometric measurements of the patients will be collected and analyzed. Detailed Description: The study will assess the changes in nutritional status, including body weight, BMI, fasting blood glucose, HbA1c, Homa-IR, iron levels, vitamin D levels, and lipid profile (triglycerides, LDL, HDL) among morbidly obese patients in the first six months following sleeve gastrectomy. Preoperative and postoperative measurements will be compared to evaluate the impact of surgery on these parameters. Conclusion: Results will be analyzed and interpreted after data collection is completed, and conclusions will be drawn accordingly.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 76
• Est. completion date: April 15, 2023
• Est. primary completion date: April 15, 2023
• Accepts healthy volunteers: No
• Gender: All
• Age group: 19 Years to 64 Years

Eligibility

Inclusion Criteria:

• 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

Exclusion Criteria:

• 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

Related Conditions & MeSH terms

• Bariatric Surgery Candidate
• Gastrostomy
• Obesity
• Obesity, Morbid

Intervention

Other:
• püPatients undergoing bariatric surgery
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.

Locations

Country	Name	City	State
Turkey	Ankara Yildirim Beyazit University	Ankara

Sponsors (1)

Lead Sponsor	Collaborator
Ankara Yildirim Beyazit University

Country where clinical trial is conducted

Turkey, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Body Weight	Kilograms (kg)	Preoperative period, postoperative months 1 and 6
Primary	BMI (Body Mass Index)	Kilograms per square meter (kg/m2)	Preoperative period, postoperative months 1 and 6
Primary	Lean Mass	Kilograms (kg)	Preoperative period, postoperative months 1 and 6
Primary	Fat Mass	Kilograms (kg)	Preoperative period, postoperative months 1 and 6
Primary	Fasting Blood Glucose	Milligrams per deciliter (mg/dL)	Preoperative period, postoperative months 1 and 6
Primary	HbA1c	Percentage (%)	Preoperative period, postoperative months 1 and 6
Primary	Iron levels	Micrograms per deciliter (µg/dL)	Preoperative period, postoperative months 1 and 6
Primary	Vitamin D level	Nanograms per milliliter (ng/mL)	Preoperative period, postoperative months 1 and 6
Primary	Lipid Profile (Triglycerides, LDL, HDL)	Milligrams per deciliter (mg/dL)	Preoperative period, postoperative months 1 and 6